Thursday, September 29, 2011

Pre Op Appointment with Orthopedic Surgeon tomorrow

Hi guys, I have kept you informed on the topics I discuss with any of my orthopedic surgeons/consults or other medical professionals with whom I have appointments.

As I have mentioned previously, my surgery is scheduled for Monday Nov 7th.  These are the remaining items on my agenda for the meeting tomorrow (hopefully my last meeting prior to surgery):

(1) Review the order for the test to detect  t (14:18) translocations in peripheral  blood lymphocytes  from my current hip. (some studies suggest there is is an increase risk of lymphoma and leukemia in patients with total hip replacements in patients with  the hip in situe for more than 10 years.  I want to know at this point whether there is an increase in the frequency of mark of mutagens  t (14:18) translocations in my blood.) While I have not had the hip for 10 years, I would like to start a baseline.  Preliminary data suggests that  t (14:18) translocation frequency is 37.5% higher in frequency than those undergoing primary hip replacement which has a frequency of 22.2%. Wear debris including the potential carcinogens of Cr and Co accumulate at highest concentration in the bone marrow and the lymph nodes.

In genetics, a chromosome translocation is a chromosome abnormality caused by rearrangement of parts between nonhomologous chromosomes. A gene fusion may be created when the translocation joins two otherwise separated genes, the occurrence of which is common in cancer

(2) My MRI showed that I have some elevated bone resorption at the top outer portion of my femur.  Given the surgeon has no plans at the moment of removing my femur (pretty extensive surgery), I would like to know what he knows now of the condition of my stem and how he knows it.  If he thinks it might be possible he discovers wear on the stem during surgery, then what?  What's the plan?

(3)   He had suggested that we look at the Pinnacle as a replacement for the ASR (both manufactured by Depuy.)  Likely one of the reasons he selected Pinnacle is that it is compatible with the stem I have now.  The stem would have to removed if we switched to another manufacturer  which I will confirm.

I would like some assurance that the recent surge in hip complaints re the Pinnacle to the FDA are based on the Metal on metal Pinnacle and not the ceramic or poly component.  I then want to know specifically, which components he intends to replace and then insert.  Also would like to know what the composition of the liner is he intends to use if there is one.  I would like to stay away from the ultra high molecular weight  stuff (associated with high wear rates).

While the overall performance of the Pinnacles are good, I only care about the performance of the exact items/materials he intends to use as a replacement.

(4) Some surgeons believe that a majority of chromium debris comes from the corrosion between the femur and head and not between the head and acetablum (rubbing of bearing surfaces.)  If this is true, why do we need to place a poly liner between two things that are not really causing the problem?

(5)  Curious about the percent of patients in his practice with MoM hips?

(6) Since my ortho surgeon has a genetics background, I would like his take on the observation that  although there is  good evidence that suggests Cr 6 is the ion responsible for most of the toxic actions,  much of the underlying molecular damge may be due to its intracellular reduction to the even more highly reactive and short lived chromium 3 and chromium 5.

Depuy maintains that the chromium found in the ASR is chromium 3.  My question:  Is the chromium 3 (known to be less toxic....NOT NON TOXIC) actually oxidized chromium 6?
Well, hope to get through these questions so I can have this surgery in peace!

Wednesday, September 28, 2011

Discovery Moves Forward In Federal DePuy ASR Hip Replacement Lawsuits

 Excerpts reprinted from Bernstein Liebhard LLP Press release

MDL is multi district litigation that enables all of the cases to be considered under one judge.

The Firm reports that on September 26, 2011, the Honorable David A. Katz, who is overseeing the DePuy ASR MDL, issued several Case Management Orders,* which will require plaintiffs' counsel to submit a Plaintiff Fact Sheet and Medical Records Authorization on behalf of their clients who have undergone revision surgery or are scheduled to undergo revision surgery.

In a mass tort case, such as the DePuy ASR MDL, Plaintiff Fact Sheets are discovery tools used by defendants (Depuy)  to obtain basic information about the plaintiff as well as specific information about the nature of plaintiff's injuries. According to the Orders, cases currently pending before the Court involving plaintiffs who have already undergone revision surgery must have Plaintiff Fact Sheets and accompanying Medical Records Authorizations submitted by December 26, 2011. Cases filed in the DePuy ASR MDL after September 26, 2011, involving plaintiffs who have already undergone revision surgery have 90 days from the date of filing to submit Plaintiff Fact Sheets and Medical Records Authorizations. Finally, plaintiffs who undergo revision surgery after their cases have been filed will have 120 days from the date of the surgery to submit the required forms. Plaintiffs must also produce documents that support their claims against defendants.  

( comments from connie: At least this litigation seems to moving along!  Likely, Depuy will review the cases and then assess the extent of the damages they feel was likely their fault.  I would guess that if, after the review, they feel that they (depuy) have a good case to refute the claims, they will be tough negotiators re settlements.  I would bet they might push to settle early if they find the cases to be a clear cut case of wrong doing on their part.)

Tuesday, September 27, 2011

Three years to recall problem implants

Reprint of an article posted in the Sydney (Australia) Morning Herald earilier today.

Mark Metherell September 28, 2011   

AFTER evidence emerged of the high failure rate of an artificial hip, it took three years for the recall of the product. This resulted in an estimated 5000 Australian patients having to undergo repeat operations.

An orthopaedic expert, Stephen Graves, told a Senate committee yesterday of his concerns about the time it took for the Therapeutic Goods Administration to act on national evidence of the high failure rate of the device, which first surfaced in 2006. Solicitors acting on behalf of people affected by the allegedly faulty hip implants filed an action against the orthopaedics manufacturer DePuy in the Federal Court yesterday seeking compensation for harm.

The claimants are also seeking punitive damages on the basis that the company, owned by the medical giant Johnson & Johnson, allowed the products to remain on the market despite sufficient evidence showing the devices were causing harm.

As many as one in eight people who received the implant required it to be replaced within five years, a number much higher than other hip replacements, the solicitors said.

Anthony Bishop, the Australian head of Johnson & Johnson, appeared before the Senate committee yesterday and offered the company's regrets.

He said the company had reimbursed more than $21 million in claims to more than 3500 patients in Australia who had registered with the company's claim processor.

Mr Bishop said on legal grounds the company would not answer questions about its response to earlier advice of the product's failure and why it took so long to withdraw it.

Australia was the first country to withdraw two DePuy hip implants in December 2009. Europe followed last August. Professor Graves, who heads the National Joint Replacement Registry, told the Herald yesterday outside the hearing that about 5000 patients with the implants had undergone repeat surgery.

He told the committee that the registry first picked up a 50 per cent higher rate in repeat surgery involving the DePuy product in 2006 and while not sure it reflected faults in the product, mentioned it to the TGA.

In 2007 the higher failure rates were confirmed and again related to the TGA, which established an expert advisory group, which after a series of further reviews recommended withdrawal in December 2009.

Rohan Hammett, the national manager of the TGA, later told the hearing that between 2006 and 2008 the orthopaedic expert advisory group - established to advise the TGA on the issue - had recommended more training of surgeons using the product because of its technical complexity.

Dr Hammett said the matter had been further complicated when a second but technically different DePuy hip implant was also found to have problems.

The Consumer Health Forum chief executive, Carol Bennett, said: ''In many cases it is not until devices are on the market that failures become apparent. Consumers want to know that when a device is failing at unacceptable levels, action will be taken promptly to contact and assist those who are already using the device and to prevent the use of the device where necessary.''

Monday, September 26, 2011

Former DePuy President Lands New Job as Orthopaedics Industry Trade Association CEO

 (exerpts from an article posted on Rottenstein's site combined with the OrthoWorx press release.)

DePuy hip replacement recall watchers may remember last March when David Floyd announced that he was resigning as president of DePuy Orthopaedics, Johnson & Johnson’s artificial orthopedic implant subsidiary. At the time DePuy’s spokesperson said that he was “pursuing outside interests.” On September 4, 2011, the Fort Wayne Journal Gazette reported that he has now been named the CEO of OrthoWorx, a trade organization for the orthopedic implant industry.

Floyd co-founded OrthoWorx, which is also located in Warsaw, Indiana, which it describes as the “orthopedics capital of the world.” Floyd’s career is filled with other top positions at orthopedic companies.

“We are delighted that David has agreed to join our organization,” chairwoman Cheryl Blanchard said in prepared remarks. “David’s industry experience as the global head of a multi-billion dollar orthopedic enterprise, his leadership in the creation and launch of OrthoWorx, and his deep connections to the Warsaw community make him ideally suited for this position.”

Floyd was a founding member of the OrthoWorx board, where he served until shortly after leaving DePuy. Named president of division in Sept. 2007, after coming over from Abbott’s (NYSE:ABT) spine division, his arrival was accompanied by some fanfare due to his connections to Warsaw – he was an executive at Warsaw-based Zimmer Holdings (NYSE:ZMH) and went to college in the area, according to a 2007 article in the Journal Gazette.

“I am delighted to join OrthoWorx and to be able to draw on my experiences in leadership and in the orthopedic industry in a different way – to help the Warsaw region continue to thrive as the orthopedic capital of the world,” he said in prepared remarks. “The orthopedic industry has been a great Indiana success story and I believe it can continue to be a powerful driver of our region’s overall economy.”
OrthoWorx was established “to advance and support growth and innovation within the region’s uniquely concentrated, globally significant orthopedics device sector,” according to its website. It’s funded in part by the Lilly Endowment and was founded in 2009.

Sunday, September 25, 2011

J&J Metal Hips Failed in More Than 25% of Cases, U.K. Says



A metal-on-metal hip implant made by Johnson & Johnson (JNJ) failed in more than a quarter of cases by the sixth year after the devices were installed, according to a U.K. medical registry.

The ASR Acetabular implant from J&J’s DePuy Orthopaedics Inc. unit was removed or replaced 29 percent of the time after six years, compared with a 9.5 percent failure rate for all metal-on-metal implants, the National Joint Registry of England and Wales said in its 2011 annual report.

Findings by the registry last year led New Brunswick, New Jersey-based J&J to recall the ASR devices. The world’s biggest hip maker faces more than 2,000 lawsuits related to its implants. Regardless of manufacturer, metal-on-metal implants need replacing more often than other types, according to the U.K. registry.

“There appears to be a sharp increase in the risk of revision at around six years after primary surgery for the metal-on-metal group although more data is needed to confirm this finding,” the registry report said.

The revised figures should be viewed in a broader context,Lorie Gawreluk, a spokeswoman for DePuy.

Evaluate ‘With Caution’

“The six-year revision rate should be interpreted with caution because it is based on a small number of cases,” she said in an e-mail. “The five-year data is more statistically robust given the much larger patient population from which it is drawn.”

The report found 17 percent of the ASR Acetabular implants were removed or replaced after five years, Gawreluk said. In the seventh year after implantation, overall removal rates for hip implants were 4.7 percent, according to the registry. The rate for metal-on-metal implants, which consist of metal balls and sockets, was 14 percent compared with 3 percent for cemented devices.

Use of metal-on-metal devices in England and Wales has declined to 5 percent of procedures in 2010 from 15 percent in 2007, the registry said.

The registry says it has the world’s largest joint database with 1.1 million records covering hip, knee and ankle joint procedures in England and Wales.

To contact the reporter on this story: Allison Connolly in Frankfurt at aconnolly4@bloomberg.net

Saturday, September 24, 2011

DePuy Argues That Hip Implant Recall Victims Missed Deadlines

I thought this was an interesting article from Brian Devine's site.  I wonder if anyone else has had this same experience?

by Brian Devine on January 31, 2011
In response to claims for injuries caused by its hip replacement recall, Johnson & Johnson subsidiary DePuy Orthopaedics argues that victims waited too long to bring their claim and are not allowed to recover any compensation. The 93,000 victims of DePuy’s hip implant recall should be aware that deadlines apply to their case and should take measures to protect their legal rights.

One victim of DePuy’s hip replacement recall filed his lawsuit just 15 days after he underwent the revision surgery to remove and replace his recalled ASR hip implant. Even though he waited only 15 days to file his lawsuit, DePuy filed court documents arguing that he waited too long to file his claim. DePuy argues that the statute of limitations bars the victim from obtaining any compensation, and DePuy asks that the Court dismiss the claim and to make the victim pay money to DePuy for its trouble.

Each state has laws that set strict deadlines by which victims must file a lawsuit. If victims who are injured by DePuy’s hip implant recall do not file their claim by this deadline, they could be forever barred from being compensated. The application of these laws, which are commonly referred to as the “statute of limitations,” is very complex. Consequently, victims of DePuy’s hip implant recall should consult with an attorney to ensure that they do not waive their legal rights.

Brian Devine, an attorney who represents several victims of DePuy’s hip implant recall said: “In every single case we have filed, DePuy argues that the victim waited too long and is not entitled to recover any compensation. It doesn’t matter if the victim filed a lawsuit as soon as they woke up from the revision surgery, DePuy claims that all of these victims waited too long and none of them should be allowed to recover compensation.”

Friday, September 23, 2011

Other Hip Recalls: In 2008-Stryker implant (6 of 6)

Stryker Hip Implant Replacement  Recall


On January 22, 2008, Stryker announced that it was recalling two products within the company’s Trident line. The Stryker Hip Implant component recall involves two hip replacement cups – the Trident Acetabular PSL Cup and the Trident Hemispherical Cups – made at the Stryker facility in Cork, Ireland. Neither of these recalls is directly related to the issues discovered at the New Jersey plant, which could result in even more investigation into this problem

Trident PSL and Hemispherical Acetabular Cups were recalled by Stryker as it had failed to maintain manufacturing procedures conforming to the FDA guidelines. The FDA warned Stryker that its product was not worth use of patients requiring hip implant surgery.


Stryker Howmedica Corporation is one of the leading manufacturers of hip implant products, and for a period of more than three years, the company has been receiving complaints in regards to its implants. As is almost always the case, these complaints began with those who used the products, and ultimately the FDA got involved with the situation as these complaints continued to be generated.

Stryker Hip Implant Problems and Recall:

The first sign of trouble for these Stryker products surfaced in January of 2005, when reports of multiple complaints by consumers using the product began to hit the news. These complaints consisted of several serious problems, including extreme pain in the surgical area, squeaky joints, the tendency for parts of the implant to break off and/or wear down unevenly, creating extreme pain and discomfort, and finally and perhaps most seriously, improper fittings of these implants that ultimately led to bone fractures in the patients’ bodies.

FDA Investigation of Stryker Hip Implants


During the summer of 2007, the FDA spent six weeks inspecting Stryker’s manufacturing facility in Mahwah, New Jersey, and as a result compiled a list of problems. Included among them were deficiencies in the quality control stages of manufacturing and the presence of disease-causing germs, including "clumps and clusters" of a form of Staphylococcus bacteria.

As a result, the FDA sent a stern warning to Stryker in November of 2007 warning them that if these problems were not corrected immediately, the FDA would begin to seize property, file injunctions and warn government agencies not to award contracts to Stryker based on the problems discovered.  The hips were recalled in 2008

Timeline Of Events And FDA Warnings To Stryker
February 3, 2003: FDA approves Stryker’s Trident hip replacement system.
January 2005 to April 2007: Stryker receives a large number of complaints from patients about their Trident hip implants, yet takes no significant action.
March 15, 2007: FDA sends a warning letter to Stryker over defecting practices in its Ireland manufacturing facility. “This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation.”
November 28, 2007: FDA sends a second warning letter to Stryker. “[C]ustomer complaints have been received for squeaking/noisy ceramic on ceramic hip joints.”
January 22, 2008: Under pressure from the FDA, Stryker initiates a voluntary recall. “As a result of the deviation from internal specifications, the Company is initiating a voluntary recall of Trident PSL and Hemispherical Acetabular Cups manufactured in its Cork facility.”

What Is The Status Of The Hip Implant Litigation?

 Numerous Stryker Hip Implant cases have been filed in New Jersey state courts because Stryker’s manufacturing facility is located there (and, Stryker is based out of Michigan, which is oftentimes a terrible place to file a lawsuit). The Supreme Court of New Jersey ordered on March 31, 2009 that those cases, and any future Stryker Hip Implant cases filed in New Jersey state courts, are to be transferred and centralized to the Superior Court, Law Division, Atlantic County before Judge Carol Higbee. For more information, please see the Court’s website. As mentioned above, plaintiffs' lawyers handling Stryker hip implant lawsuits are now optimistic settlement talks to resolve these cases may bear fruit in the near future.
Additionally, patients are filing lawsuits in their home states, as well.

Stryker’s Trident line of hip implants uses ceramic-on-ceramic components rather than metal-on-metal or metal-on-plastic components. Patients have complained about pain, difficulty in walking, pieces of the ceramic materials breaking off and wearing unevenly and perpetual squeaking. Nearly 11 percent of patients experience squeaking. 

Wednesday, September 21, 2011

Other Hip Recalls: In 2008-Zimmer Durom Implant (5 of x)

2008 hip recall:

    Zimmer Durom Hip Replacement Implant

In 2008, Zimmer Holdings suspended sale of Durom Acetabular Cup following numerous complaints of a high implant failure rate. Since 2006, when Durom Cup came to be used in the United States, numerous complaints and lawsuits have been filed against Zimemr Holdings. Most of the lawsuits filed against Zimmer allege that the defendant did not disclose the risks associated with the hip implant cup when it marketed the product. However, Zimmer continues to deny the allegations, precisely blaming the surgeons for the high hip implant failure rate. Many patients have complained that the Durom Cup failed within two years of implantation, as a result of which, they had to bear severe pain and undergo a revision surgery.

Zimmer Durom Cup Dangers

The Durom Cup had been implanted in more than 12,000 patients in the country from 2006 to 2008. According to reports, about 11 percent of the Durom Cup implants failed in the first two years. However, Zimmer claims that the product can last for 15 years, saying that the metal hip replacement system is far more durable than traditional implants.

In fact, the Durom Cup is a metal-on-metal hip replacement system, with multiple metal components designed to fit into a “ball and socket” formation. As the ball rotates and rubs against the cup-like socket, it sometimes presses against the edge of the cup, thus generating a large volume of microscopic metal shavings into the patient’s bloodstream. The metallic debris can be absorbed by the soft tissue, resulting in

Zimmer Durom Cup Design and Failure

The Durom Cup is designed to fit into the cup-shaped depression of the hip joint so that it holds the femoral head. However, reports suggest the Durom Cup does not fuse properly with the hip joint due to failure of necessary bond.  Many surgeons complain that the problem lies with the fixation surface of the Durom Cup, having a plasma-sprayed titanium coating, which is actually meant to facilitate natural growth of the hip bone on the surface of the device. Zimmer Durom Cup does not have any attachment device that would hold the implant and only relies on the bony ingrowth to hold the implant and secure cup positioning. However, lack of bony ingrowth in many patients resulted in cup loosening, causing hip implant failure.

In February 2011, the FDA warned that some "unique risks" were associated with metal-on-metal artificial hips due to the wear and tear of tiny metal ions, which can damage the nearby tissue.  A number of individuals who received the Durom Cup between 2006 and 2008 have sued Zimmer Holdings for their device failure, pain and suffering, physical and emotional distress, injury, shame and humiliation, medical expenses, disability, mental anguish, memory impairment, punitive damages, loss of enjoyment in life, and inability to lead a normal life.

From Zimmer Hip Law Suit Center:
http://zimmerhiprecall-info.com/2011/08/zimmer-hip-multidistrict-litigation-lawsuit-settlements/

Zimmer hip litigation and  settlement fund

Since the Zimmer hip was voluntarily recalled by Zimmer Inc. in July 2008, almost $150 million has been set aside as compensation for those who were fitted with the Durom Cup. Because a number of settlement agreements have not been made, many speculate that what remains of the fund may not be enough to cover the remaining settlements when the rest of the cases are resolved. The exact dollar amount needed to cover the remaining unresolved cases will not be known until the cases are resolved. It is also possible that no other settlements will be paid out of the fund if Zimmer hip lawyers fail to prove their cases in court. The remaining cases will not go to court until later this year or early next year.

Earlier in 2011, all cases involved in the Zimmer hip multidistrict litigation cases were ordered to go to mediation. A number of Zimmer hip lawyers have successfully negotiated settlements for their clients. However, seven cases failed to agree on a settlement and will move further into the litigation process. Depositions were scheduled to begin on June 15th. Zimmer hip lawyers were scheduled to provide updates on the status of their cases at a conference scheduled for June 29th. No newsworthy information came from the conference.


In order to understand the latest news associated with Zimmer hip multidistrict litigation, those affected by the lawsuit should understand what multidistrict litigation is and how it affects the Zimmer hip settlement. Multidistrict litigation is a process that the federal court system uses to transfer all open/pending civil cases of a similar nature filed in the United States to one federal judge. The decision to transfer cases to one federal judge is made by a panel of seven federal judges that are selected by the Chief Justice of the U.S. Supreme Court.

Judge Susan D. Wigenton of the New Jersey federal court was assigned the Zimmer hip multidistrict litigation.

Zimmer Hip Lawsuit Class Action Approved by Canadian Judge

Ryan Green | September 13th, 2011 | Posted in Zimmer Hip Lawsuit News
A Canadian Supreme Court judge has approved a class action Zimmer hip implant lawsuit against the artificial joint manufacturer. Any Canadian citizen who has experienced Zimmer hip problems with their Durom Cup acetabular device is technically eligible to join the Zimmer hip class action lawsuit.

Zimmer hip problems lead to class action Zimmer hip implant lawsuit

Zimmer Hip Lawsuit Class Action Approved by Canadian Judge
Ryan Green | September 13th, 2011 | Posted in Zimmer Hip Lawsuit News

A Canadian Supreme Court judge has approved a class action Zimmer hip implant lawsuit against the artificial joint manufacturer. Any Canadian citizen who has experienced Zimmer hip problems with their Durom Cup acetabular device is technically eligible to join the Zimmer hip class action lawsuit.
A class action lawsuit is one in which multiple plaintiffs join together to bring a single complaint of wrongdoing against a shared defendant. In the case of the Canadian Zimmer hip class action lawsuit, patients who allege problems with a specific hip implant known as the Durom Cup have joined together to file a single legal action.

Zimmer hip litigation consolidated in New Jersey

When Durom Cup litigation was consolidated in a New Jersey court last year, more than 50 plaintiffs were involved. The litigation grew from there to include many more plaintiffs, and the litigation continues to grow today. Theoretically, more than 12,000 plaintiffs could join the litigation as there were that many Americans fitted with the Durom Cup when the device was temporarily pulled from the market in 2008.

In June of 2011, pretrial litigation is proceeding in a New Jersey court, where a Zimmer hip lawyer may soon begin taking depositions, as per an order issued by presiding Judge Madeline Cox Arleo. On June 29, defendants and plaintiffs will meet before Judge Arleo in a Durom Cup litigation status conference. The first Durom Cup trial could begin later this year or in 2012.


[Comments by Connie:  Do you see how long this kind of litigation takes?  Amazing.  This hip was recalled in 2008.  It seems to be going to trail in 2012!  They went the route of multidistrict litigation which is the same route taken in the Depuy case.]

Tuesday, September 20, 2011

Other Hip Recalls: In 2007-Smith and Nephew Brimingham Hip (4 of x)

  Smith & Nephew Birmingham Hip Replacement Recall

In 2007, Smith & Nephew recalled about 185 Birmingham hip resurfacing system implants over improper packaging by a subcontractor. As a result of the packaging error, it was reported that different sizes of acetabular cups were mixed and mislabeled. A number of patients have complained of having received wrong-sized hips, which has forced them to undergo a revision surgery to remove and replace the improperly fitting hip that has been wearing out quickly and causing extreme complications for them.

Smith & Nephew blamed the error on a subcontractor that mislabeled thedevices, which caused a mismatch between the two hip implants. This meant that patients requiring a hip device of a different size received a mislabeled hip implant, which resulted in their hip implant failure.

The mismatched pieces result in loosely fitting implants. Patients that have undergone hip replacement surgery using Smith & Nephew Birmingham hip device are advised to consult their doctors and go for a post-operation X-ray to confirm whether they have properly fitting implants.

In case they are found to have the improperly fitting hip device, revision surgery is the only solution.

Recently, the Federal Drug Administration warned Smith & Nephew PLC about the quality control problems at one of the company’s plants in Germany, which manufactures hip replacement implants.  The warning letter calls for corrective action at Smith & Nephew’s Tuttlingen, Germany, production unit, where R3 Ceramic Acetabular System is manufactured.  Before issuing the warning, FDA inspection teams visited the plant in July 2010 and raised a few serious concerns, including failure of the company to confirm validity of the Germany plant’s maximum and minimum settings for equipment used to press titanium rings. The company’s response to the concerns was deemed insufficient by the FDA.

The inspection team also found that the Germany plant did not verify that corrective actions to fix a problem with radiation-sterilized plants were actually working. The FDA inspectors found that no procedure was in place at the plant facility to ensure that the fixes were working.  However, the plant put the entire blame on its employees’ failure to follow the new procedure. The FDA inspection report found that the company’s processes to validate the quality of its products lacked in numerous areas.

The metal-on-metal Birmingham Hip Resurfacing System is surgically implanted to replace a hip joint damaged due to degenerative diseases, including rheumatoid arthritis, osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia; improve hip function; and relieve hip pain.

However, this metal-on-metal hip device has proved troublesome for many patients, who have experienced metallosis and extreme pain due to deposition of fluid and debris around the hip joint as a result of the wearing off of the metal particles. In such a case, the hip cup impinges or rubs on surrounding muscle, which eventually causes the joint to wear off, resulting in metal ion poisoning and generating immense pain.

Many patients have experienced flu-like symptoms, including lethargy, headaches, aching joints, and a feeling of malaise. So far, more than 50,000 patients have received Birmingham Hip Resurfacing implants, and that the number of affected patients is on the rise.
Smith and Nephew Implant Recalls
Earlier, Smith & Nephew recalled their Oxinium Profix II and Oxinium Genesis knee replacement systems over reports that the knee replacement devices did not bond properly, thus putting patients at an increased risk of infection, extreme pain, and joint and muscular damage. The patients even had to undergo a revision surgery for the removal and replacement of their defective knee devices, which was also not devoid of other complications. At the time of the recall, the manufacturer reported a one percent revision rate. But the number of secondary surgeries increased many-fold thereafter, with more than 765 patients having to undergo revision surgery.
(from Law suit news alerts)

Monday, September 19, 2011

Other Hip Recalls: In 2001-St. Gobain Desmarquest Case (3 of x)

2001 Recall.

The U.S. Food and Drug Administration had announced the second major recall of hip implants within the past year. On August 14,  2001, French manufacturer St. Gobain Desmarquest voluntarily recalled nine batches of zirconia ceramic femoral heads, the "ball" portion of the hip prosthesis. The potentially defective components were manufactured since early 1998 when St. Gobain Desmarquest changed part of its manufacturing process. One report suggests that the ceramic was left more fragile following a change in the heating process during manufacturing.

The recall of the zirconia ceramic femoral heads occurred following a higher than expected fracture rate in some patients, 13 to 27 months post-op. The FDA reported 14 cases of Americans who experienced fracture of the recalled hip implant.

Companies Affected


The zirconia ceramic components were distributed by more than 51 companies worldwide. Eight U.S. companies used St. Gobain Desmarquest zirconia ceramic femoral heads and participated  in the recall:

  • Apex Surgical, LLC (Lakeville, Massachusetts)
  • Biomet, Inc., (Warsaw, Indiana)
  • DePuy Orthopaedics, Inc. (Warsaw, Indiana)
  • Encore Orthopaedics, Inc. (Austin, Texas)
  • Osteoimplant Technology Inc. (Hunt Valley, Maryland)
  • Smith & Nephew, Inc. (Memphis, Tennessee)
  • Stryker Howmedica Osteonics (Allendale, NJ)
  • Zimmer, Inc. (Warsaw, Indiana)

Key Points

It was estimated that between 150,000 and 200,000 hip implants were performed each year in the United States int he early 2000's. Hip implants with zirconia ceramic femoral heads were used in less than 6 percent of hip replacement surgeries performed in the United States.

·  Not all zirconia ceramic femoral heads were expected to fail. The recall only applies to unimplanted zirconia ceramic femoral heads.

·  The FDA did not recommending surgery to replace hip implants that have not fractured or are not causing problems.

·  Sudden pain in the implanted hip joint often preceded by an audible "pop" often signal fracture of the defective component. Surgical correction is necessary if fracture does occur.

·  No test could  be performed to predict which patients will experience fracture of their zirconia ceramic femoral head component.

·  Patients with the potentially defective implant should be monitored more closely by their physician. Patients were being advised to contact their surgeons with any questions or concerns.

The issue raised in the manufacturing  Process
Change in manufacturing procedure Up until 1997, sintering was performed by SGCA-Desmarquest in a batch furnace, where an array of materials are placed at room temperature, then gradually heated, held at a higher temperature, and finally cooled back to room temperature. In early 1998, the company installed and began using a tunnel furnace, which operates by using a conveyor belt to move the items through multiple heating chambers. As it turned out, the first batches produced were the ones exhibiting the high rates of cracking. In a study of the failure mechanisms, Masonis et al found that the tunnel furnace and batch furnace exhibited the same temperature profiles upon heating to a maximum temperature of 1450 C, but differed in their cooling stage. Masonis found that the time for the materials to reach room temperature was three times shorter for the tunnel furnace than for the batch furnace. Upon examination of explanted, failed heads in the recalled batches, significantly elevated levels of monoclinic phases were found. In fact, a 100% transformation from the tetragonal phase to the monoclinic phase was found near the bore surface in a failed head from the tunnel furnace.
Saint-Gobain Desmarquest reported that using its batch furnace from 1990-1997, of 280,000 heads used, there were only 6 reported fractures equivalent ot about 1 fracture in every 46,000. [11] But once the tunnel furnace was employed, Masonis et al reported a 2.2% overall fracture rate in the 13 batches involved in the recall. This amounts to a 1 in 50 failure rate. Reported failure rates varied from batch to batch. Within the group of 13 recalled batches, the highest failure rate exhibited was 24% or 154 fractures in 655 hips (Batch TH 93038). In America, 39 zirconia heads from this batch were implanted, and by May 2002, 44% had fractured, while another batch, TH 9205 had 68 fractures in 611 patients worldwide.
Litigation:
It seeem that there were a number of suits filed but they seemed to have been filed against each company that used the materials and distributed the ceramic hip which are listed above.  I can't find any evidence of class action or a multi disctrict litigation effort.  This was 10 years ago so perhaps those proceedures weren't employed then?

Sunday, September 18, 2011

Other Hip Recalls: Sulzer in 2001 (2 of x)

In 2001, Sulzer voluntarily recalled a lot of  its acetabular shell (aka, socket.)  This was a manufacturing defect whereby  during the manufacturing process, a small amount of mineral oil-based lubricant leaked into the machine coolant, and even after the cleaning process, the lubricant remained as residue on the shell.

Sulzer Hip Implant Recall


Sulzer Orthopedics, a subsidiary of Sulzer Medica, has recalled certain lot numbers of its Inter-Op acetabular shells. Most of the recalled hip replacement products were manufactured during or after October 1999 but a limited number were produced as early as June 1997. The affected lot numbers of the Inter-Op acetabular shell included approximately 25,000 units of which 17,500 were implanted.
In September 2000, Sulzer Orthopedics of Austin, Texas, the manufacturer of the defective implant, began receiving adverse reports from doctors. Following an 8-week investigation of patient records, surgical techniques, and the product itself, the recall was ordered. It was ultimately found that during the manufacturing process a small amount of mineral oil-based lubricant leaked into the machine coolant, and even after the cleaning process, the lubricant remained as residue on the shell. No other implant manufactured by Sulzer, other than the Inter-Op acetabular shell, was affected. Since the problem was identified, steps in the manufacturing process have been either eliminated or modified to prevent a recurrence of the problem.

Designed so that the acetabular component snaps into place and bone grows into it, the oily residue interfered with the bonding. Some people who have received the defective implant have reported loosening and have required further surgery to revise the failed hip replacement. Patients who had the acetabular component cemented in place are unaffected by the recall.

Sulzer Recommendations at the time


Although the FDA has not required it, Sulzer Orthopedics has recommended that surgeons contact patients who received the Inter-Op shells from the affected lots. To recognize if there is a problem with an Inter-Op shell implant, Sulzer recommends patients and surgeons be aware of the following symptoms:

  • Sedimentation rate, C-reactive protein, and aspiration show no evidence of infection preoperatively.
  • All cultures at surgery are negative and an arthrogram does not show dye around the shell.

Up to 6 weeks post-op

  • The patient may be progressing well, or may be reporting pain in the groin or anterior trochanteric area.
  • Patient may have increased thigh pain.
  • Patient may have significant pain when starting to walk, or buttock pain after rising from seated position.
  • X-ray may show possible migration of the component

Hip Implant Class and Sulzer Will Settle Case for $1 Billion

The revised settlement, approved by the Court in May 2002, provided patients with defective implants almost twice the cash payment as under an initial settlement.

by Jahna Berry
THE RECORDER

The settlement checks are in the mail.

On Friday, Sulzer Orthopedics Inc., the company that was mired in national litigation over thousands of recalled hip and knee implants, approved a $1 billion settlement. The announcement means that many patients and lawyers will begin to get payments from Sulzer some time before the end of the year, a lawyer said.

Typically, a person who had one surgery to replace a bad implant would get $260,000, plus medical expenses. His or her attorney would get more than $40,000 in fees out of the patients’ gross award.
As the litigation neared its conclusion there was widespread fear that the deal would fall apart if many of the rank and file plaintiffs decided to try their luck in trial. Lead plaintiff attorneys warned that too many opt-outs would force the company under — narrowing the chance that all patients would be compensated.

“It was a real nail-biter,” said Orinda attorney Luke Ellis (Gillin, Jacobson, Ellis & Larsen), who represented 35 plaintiffs. “It went down to the wire.”

In fact, at one point 132 plaintiffs opted out; 35 were patients with serious claims who could have waged deal-busting legal battles. Lawyers from the plaintiffs team worked the phones and whittled that number from 35 to 16.

A little more than 3,000 people so far have had surgery to replace the defective hip and knee implants. Sulzer has said that about 4,000 people will be covered by the agreement. Not all patients who got the implants will develop problems, and some implant recipients are medically unable to undergo surgery.
In the upcoming months, U.S. District Judge Kathleen O’Malley also will decide which plaintiffs lawyers will share in the $50 million fee award for lawyers who played a big role in the settlement.

xxx

Sulzer  also established a $100,000,000 Extraordinary Injury Fund, that will provide compensation for serious complications arising from the defective implants.

Ellis said that because the average age is over 60 in these cases, there were some pretty serious complications: dislocations or fractures as a result of the defective part, stroke, heart attack -all those things happened, which isn't surprising, given the age group. People with these extraordinary injuries are eligible for up to one million.

Sulzer, he added, estimates that maybe a quarter of the 3,800 [who required additional surgery] might be eligible for the fund."

xxx

[ from connie:  there are several things I noted from this case:
  1. The "injuries" seemed to be one time issues with no residual potential of long term impairment such as cancer as a result of the injury as there clearly is in the Depuy case.
  2. There seemed to be nothing to study in terms of the potential long term effects of this lubricant on the future health of the patients.
  3. There seemed to have been no potential for organ damage such as exists with the Depuy case in the Kidneys and other areas.
These are big issues which MUST  be addressed in the settlement with the Depuy case.  That is:
  • Funds must be allocated by Depuy to study the long term affects of the metal on the patient population
  • a extraordinary injury fund needs to be established to cover the potential cancer issues that have been studied and linked to this metal effect long term on the organs of patients who will inevitably affected.
As patients who might have long term complications from this metal issue, it is imperative that any settlement MANDATE that Depuy fund longer term studies on this issue.  What good will be served by paying out patients a few hundred thousand dollars if no one clearly understands the long term effects of cancer work that has been done to date on this issue?

The lawyers on this case need to be cleaver and utilize other options to look at the long term affects of this problem.  If I see any law firms who have put the long term systemic issues front and center along with the idea of mandating long term funding to study the issues further, I will let you know.

I have not engaged a law firm yet.  I have up to two years in NY since I was made aware of this problem until the statue of limitations runs out.  BE CAREFUL GUYS THAT YOU CHECK WITH A LAWYER TO ENSURE THAT IF YOU CHOOSE TO FILE A CASE, YOU DO SO PRIOR TO THE STATUE OF LIMITATIONS EXPIRE FOR YOUR STATE OR PARTICULAR SITUATION.  the statues seem to vary from state to state.

 Once I have some kind of assurance that these two issues will  be key issues ADDRESSED in a settlement, I would sign up.

If Depuy wants to settle this case, they should provide some assurances that these issues will be addressed. If the lawyers don't ask for these to be a part of the settlement, shame on them.   No patients should settle for anything less.]

Thursday, September 15, 2011

Other Hip recalls (1 of x)

Thought it might be interesting to look at some of the other hip recalls to get a sense of what happened with those recalls so I will do that over  the next 6 or 7 posts.   I didn't realize there were so many.  Not sure this is a complete list but I'll look at each one.

There is an FDA site which lists all of the medical device recalls since 2000:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153189.htm


Some additional companies of the artificial hip manufacturers that have been forced to recall their defective products include:
  • Apex Surgical
  • Encore Orthopedics
  • Stryker Howmedica
  • Sulzer Inter-Op Acetabular Shell
  • Zimmer
  • Biomet, and DePuy Orthopedic
should be interesting..  I will dig up some of this information and report on it.

Wednesday, September 14, 2011

Reviewing the historical Journal literature for publications discussing Cancer risk associated with joint/hip implants (9 of 9)

I would like to close this series with a NEW publication in 2011.  I found it fascinating.

Some definitions are in order as usual before plunging into this abstract:

What the heck is  drosophila melansogaster? Fruit fly!

Drosophila melanogaster (Greek for dark-bellied dew lover : δρόσος = dew, φίλος = intimate friend, lover, μέλας = dark-coloured, γαστήρ = belly[2]) is a species of Diptera, or the order of flies, in the family Drosophilidae. The species is commonly known as the common fruit fly or vinegar fly. Starting from Charles W. Woodworth, this species is one of the most commonly used model organisms in biology, including studies in genetics, physiology, microbial pathogenesis and life history evolution because they are easy to take care of, breed quickly, and lay many  eggs.

You might ask why I reprinted this after reading it so let me tell you why up front.  As you know from previous work and studies that have been reprinted here, there have been nore than enough questions raised about whether in fact the current alleged non toxic chromium 3 is nothing more than chromium 6 (Toxic form) oxidized to chromium 3. One example of this can be found in its entirety at this link:  http://www.mydepuyhiprecall.com/2011/03/mechanisms-of-chromium-toxicity.html

There is good evidence from the clinic and the laboratory that Cr[VI] is the ion responsible for most of the toxic actions, although much of the underlying molecular damage may be due to its intracellular reduction to the even more highly reactive and short-lived chemical species Cr[III] and Cr[V]. Exposure to Cr[VI] can result in various point mutations in DNA and to chromosomal damage, as well as to oxidative changes in proteins and to adduct formation. The relative importance of these effects of chromium ions and of the free oxidising radicals they may generate in the body in causing tumours and allergic sensitisation remain to be demonstrated. Biochemical studies of the DNA-damaging effects and of the pathogenesis of the allergic reactions to chromium ions have not kept up with advances in understanding of the molecular basis of the effects of other carcinogens and allergens.

Another definition is in order as well prior to reading this doc:

DNA repair refers to a collection of processes by which a cell identifies and corrects damage to the DNA molecules that encode its genome. In human cells, both normal metabolic activities and environmental factors such as UV light and radiation can cause DNA damage, resulting in as many as 1 million individual molecular lesions per cell per day.[1] Many of these lesions cause structural damage to the DNA molecule and can alter or eliminate the cell's ability to transcribe the gene that the affected DNA encodes. Other lesions induce potentially harmful mutations in the cell's genome, which affect the survival of its daughter cells after it undergoes mitosis. As a consequence, the DNA repair process is constantly active as it responds to damage in the DNA structure. When normal repair processes fail, and when cellular apoptosis does not occur, irreparable DNA damage may occur, including double-strand breaks and DNA crosslinkages.[2][3]
The rate of DNA repair is dependent on many factors, including the cell type, the age of the cell, and the extracellular environment. A cell that has accumulated a large amount of DNA damage, or one that no longer effectively repairs damage incurred to its DNA, can enter one of three possible states:
  1. an irreversible state of dormancy, known as senescence
  2. cell suicide, also known as apoptosis or programmed cell death
  3. unregulated cell division, which can lead to the formation of a tumor that is cancerous

ok here you go!

Mutat Res. 2011 May 18;722(1):44-51. Epub 2011 Mar 5.

Tracing the tracks of genotoxicity by trivalent and hexavalent chromium in Drosophila melanogaster.


Source

Embryotoxicology Section, Indian Institute of Toxicology Research, Lucknow 226 001, India.

Abstract

Mutagen sensitive strains (mus) in Drosophila are known for their hypersensitivity to mutagens and environmental carcinogens. Accordingly, these mutants were grouped in pre- and post-replication repair pathways. However, studying mutants belonging to one particular repair pathway may not be adequate for examining chemical-induced genotoxicity when other repair pathways may neutralize its effect. To test whether both pre-and post-replication pathways are involved and effect of Cr(III)- and Cr(VI)-induced genotoxicity in absence or presence of others, we used double mutant approach in D. melanogaster. We observed DNA damage as evident by changes in Comet assay DNA migration in cells of larvae of Oregon R(+) and single mutants of pre- (mei-9, mus201 and mus210) and post- (mei-41, mus209 and mus309) replication repair pathways and also in double mutants of different combinations (pre-pre, pre-post and post-post replication repair) exposed to increasing concentrations of Cr(VI) (0.0, 5.0, 10.0 and 20.0 μg/ml) for 48 h. The damage was greater in pre-replication repair mutants after exposure to 5.0 μg/ml Cr(VI), while effects on Oregon R(+) and post replication repair mutants were insignificant. Post-replication repair mutants revealed significant DNA damage after exposure to 20.0 μg/ml Cr(VI). Further, double mutants generated in the above repair categories were examined for DNA damage following Cr(VI) exposure and a comparison of damage was studied between single and double mutants. Combinations of double mutants generated in the pre-pre replication repair pathways showed an indifferent interaction between the two mutants after Cr(VI) exposure while a synergistic interaction was evident in exposed post-post replication repair double mutants. Cr(III) (20.0 μg/ml) exposure to these strains did not induce any significant DNA damage in their cells. The study suggests that both pre- and post-replication pathways are affected in Drosophila by Cr(VI) leading to genotoxicity, which may have consequences for metal-induced carcinogenesis.

Tuesday, September 13, 2011

Reviewing the historical Journal literature for publications discussing Cancer risk associated with joint/hip implants (8 of x)

(this series is looking at articles that began suspecting the relationship between cancer risk and metal on metal hips since 1995.)
 
Couple of definitions might be in order before you read this abstract:
 
In genetics, a chromosome translocation is a chromosome abnormality caused by rearrangement of parts between nonhomologous chromosomes. A gene fusion may be created when the translocation joins two otherwise separated genes, the occurrence of which is common in cancer.
 
Aneuploidy is an abnormal number of chromosomes, and is a type of chromosome abnormality. An extra or missing chromosome is a common cause of genetic disorders (birth defects). Some cancer cells also have abnormal numbers of chromosomes.
 
Senescence or biological aging is the change in the biology of an organism as it ages after its maturity. Such changes range from those affecting its cells and their function to that of the whole organism. There are a number of theories as to why senescence occurs, including ones that claim it is programmed by gene expression changes and that it is the accumulative damage of biological proces
 
In mitosis, one cell divides to produce two genetically identical cells
 
 In genetics, genotoxicity describes a deleterious action on a cell's genetic material affecting its integrity. Genotoxic substances are known to be potentially mutagenic or carcinogenic, specifically those capable of causing genetic mutation and of contributing to the development of tumors
 
Remember, this study is looking at effects from metal on metal in vitro (isolated lab type experiment) vs in vivo whereby the test is done on the organism in its normal intact state.
xxxxxxx
Mutat Res. 2007 Jun 1;619(1-2):45-58. Epub 2007 Jan 25.

Genotoxic effects of particles of surgical cobalt chrome alloy on human cells of different age in vitro.

Source

Bristol Implant Research Centre, Avon Orthopaedic Centre, Southmead Hospital, Bristol BS10 5NB, United Kingdom.

Abstract

Humans are exposed to metals from industry, the environment and from wear debris from worn orthopaedic joint replacements. Patients exposed to worn cobalt chrome hip replacements show an increase of chromosome aberrations in the bone marrow adjacent to the implant and an increase of chromosome translocations and aneuploidy in the peripheral blood. This study has tested whether particles of surgical cobalt chrome alloy are able to induce similar DNA damage and chromosome aberrations in human cells in vitro. Because increasingly young patients are receiving hip replacements it has also tested whether the response is altered at different cellular age in vitro. Primary human fibroblasts, were tested at different pre senescent population doublings (PD10 (young) and PD35 (older)) to particles of cobalt chrome alloy for up to 15 days. As in patients there was an increase of aneuploidy, chromosome translocations and DNA damage after exposure to the cobalt chrome particles in vitro. The overall level of DNA damage and numerical and structural aberrations was approximately the same in young and older cells. However, the cellular reaction to the DNA damage was different. Older cells showed a greater loss of viability and induction of senescence and a lesser rate of mitosis and cell growth than young cells. They showed less change in transcription, particularly of p38 and caspase 10 mRNA levels, than young cells. They showed more complex aneuploidy in association with unseparated or prematurely separated chromatids. This study suggests that at least part of the chromosome changes in patients with worn implants may be due to direct effects of the metal wear particles from the implant. It would be of interest to test whether the altered reaction of the human cells at different in vitro age might correspond with a different incidence of chromosome aberrations in patients at different ages.

Monday, September 12, 2011

Reviewing the historical Journal literature for publications discussing Cancer risk associated with joint/hip implants (7 of x)

(this series is looking at articles that began suspecting the relationship between cancer risk and metal on metal hips since 1995.)
J Bone Joint Surg Br. 2005 May;87(5):628-31.
Metal ion levels after metal-on-metal proximal femoral replacements: a 30-year follow-up.

Dunstan E, Sanghrajka AP, Tilley S, Unwin P, Blunn G, Cannon SR, Briggs TW.

Source

Royal National Orthopaedic Hospital, Brockley Hill, Stanmore, Middlesex HA7 4LP, UK. erdunstan@aol.com

Abstract

Metal-on-metal hip bearings are being implanted into younger patients. The consequence of elevated levels of potentially carcinogenic metal ions is therefore a cause for concern. We have determined the levels of cobalt (Co), chromium (Cr), titanium (Ti) and vanadium (Va) in the urine and whole blood of patients who had had metal-on-metal and metal-on-polyethylene articulations in situ for more than 30 years. We compared these with each other and with the levels for a control group of subjects. We found significantly elevated levels of whole blood Ti, Va and urinary Cr in all arthroplasty groups. The whole blood and urine levels of Co were grossly elevated, by a factor of 50 and 300 times respectively in patients with loose metal-on-metal articulations when compared with the control group. Stable metal-on-metal articulations showed much lower levels. Elevated levels of whole blood or urinary Co may be useful in identifying metal-on-metal articulations which are loose.


Sunday, September 11, 2011

Reviewing the historical Journal literature for publications discussing Cancer risk associated with joint/hip implants (6 of x)

(this series is looking at articles that began suspecting the relationship between cancer risk and metal on metal hips since 1995.)

Clin Orthop Relat Res. 2004 Dec;(429):86-93.

Metal-on-metal total hip arthroplasty: the concerns.


Source

Division of Orthopaedic Surgery, University of Western Ontario & London Health Sciences Centre, University Campus, 339 Windermere Rd., London, Ontario N6A 5A5, Canada. steven.macdonald@lhsc.on.ca

Abstract

The metal-on-metal bearing couple is having a resurgence in clinical applications seen in total hip and hip resurfacing technologies. The most noteworthy advantage of a metal-on-metal implant is the improved wear characteristics seen in vitro on wear simulators and in vivo with retrieved implants. All bearings have disadvantages, and a metal-on-metal bearing is no exception. Concerns exist regarding the generation of metal ions seen in the blood and urine of patients with metal-on-metal implants. These elevated metal ions have theoretical, although not proven, risks related to carcinogenic and biologic concerns. Additionally, concerns exist regarding hypersensitivity, increased incidence of instability and increased costs. Specific patient selection issues arise with metal-on-metal implants. The current generation of implants has only early and mid-term results available, with no long-term series yet published. Therefore, although a metal-on-metal bearing may be considered a viable alternative to either polyethylene or ceramic implants, outstanding and unresolved issues continue to exist with this bearing, as they do with the alternative