Sunday, February 9, 2014

HRT reduces need for arthroplasty

Edocronology Update

Hormone replacement therapy (HRT) taken regularly after knee or hip arthroplasty dramatically cuts the risk of repeat surgery, according to new UK research.

Women who took HRT for at least six months after their joint replacement surgery were almost 40% less likely to need a revision within three years, data from nearly 11,000 joint surgery patients showed.

And for those on HRT for a year or more following surgery, risk of revision was halved, the study authors from the University of Oxford found.

“Higher adherence to HRT, as well as longer duration of the treatment, appeared directly related to improved effects on implant survival,” the authors wrote in Annals of the Rheumatic Diseases

Cobalt Levels association with early failure of MoM devices

BMJ Open

The clinical implications of elevated blood metal ion concentrations in asymptomatic patients with MoM hip resurfacings: a cohort study

David J Langton, Raghavendra P Sidaginamale, Thomas J Joyce, Shonali Natu, Peter Blain, Robert Drysdale Jefferson, Stephen Rushton, Antoni V F Nargol
Langton DJ, Sidaginamale RP, Joyce TJ, et al. BMJ Open 2013;3:e001541. doi:10.1136/bmjopen-2012-001541


To determine whether elevated blood cobalt (Co) concentrations are associated with early failure of metal-on-metal (MoM) hip resurfacings secondary to adverse reaction to metal debris (ARMD). Design: Cohort study. Setting: Single centre orthopaedic unit.


Following the identification of complications potentially related to metal wear debris, a blood metal ion screening programme was instigated at our unit in 2007 for all patients with Articular Surface Replacement (ASR) and Birmingham MoM hip resurfacings. Patients were followed annually unless symptoms presented earlier. Symptomatic patients were investigated with ultrasound scan and joint aspiration. The clinical course of all 278 patients with ‘no pain’ or ‘slight/occasional’ pain and a Harris Hip Score greater than or equal to 95 at the time of venesection were documented. A retrospective analysis was subsequently conducted using mixed effect modelling to investigate the temporal pattern of blood Co levels in the patients and survival analysis to investigate the potential role of case demographics and blood Co levels as risk factors for subsequent failure secondary to ARMD.


Blood Co concentration was a positive and significant risk factor (z=8.44, p=2×10–16) for joint failure, as was the device, where the Birmingham Hip Resurfacing posed a significantly reduced risk for revision by 89% (z=−3.445, p=0.00005 (95% CI on risk 62 to 97)). Analysis using Cox-proportional hazards models indicated that men had a 66% lower risk of joint failure than women (z=−2.29419, p=0.0218, (95% CI on risk reduction 23 to 89)).


The results suggest that elevated blood metal ion concentrations are associated with early failure of MoM devices secondary to adverse reactions to metal debris. Co concentrations greater than 20 μg/l are frequently associated with metal staining of tissues and the development of osteolysis. Development of soft tissue damage appears to be more complex with females and patients with ASR devices seemingly more at risk when exposed to equivalent doses of metal debris.

As Seen on TV, a medical mystery involving hip implants is solved...cobalt Poisoning

New York Times
Feb 6th, 2014

By a strange coincidence, two leading medical journals on Thursday published case studies of the same arcane medical mystery. In one, doctors solved the riddle only after the patient, a middle-aged woman, got so sick she had to have a heart transplant. But in the other, a physician who teaches at the University of Marburg in Germany found the clues in Season 7, Episode 11, of the Fox television show “House.”

It turned out that Dr. Gregory House, the cantankerous, fictional diagnostician modeled on Sherlock Holmes, had used his powers of deduction to diagnose the very same ailment in a woman played by the actress Candice Bergen on an episode that first aired in 2011.

In this case of life imitating art — or at least television — a paper in The Lancet, a London-based medical publication, described how an ailing man in Germany had gone from doctor to doctor, seeking a diagnosis as his condition worsened.

His problems began about three years ago. He had low thyroid hormone levels, inflammation of his esophagus and fever of unknown origin. His loss of vision was so profound he was almost blind, and his loss of hearing so severe he was almost deaf. Most perilous of all, his heart had weakened so much it could not pump hard enough to supply blood to his body.
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Two case studies published on Thursday traced high levels of cobalt in patients in Colorado and Germany to metal-on-metal hip implants. Joshua Borough for The New York Times
Heart failure usually follows coronary artery disease, but this man’s arteries were fine. Doctor after doctor was stumped.

Finally, in May 2012, the man, then 55, arrived at a University of Marburg clinic run by Dr. Juergen R. Schaefer, who specializes in puzzling cases and happens to be a major fan of “House.” In fact, Dr. Schaefer uses “House” in teaching medicine, and he realized his patient’s symptoms were eerily similar to those of Ms. Bergen’s character on the show. In that episode, she, too, had heart failure. Dr. House’s diagnosis: cobalt poisoning from her artificial metal hip.

Dr. Schaefer’s patient had had an artificial ceramic hip that failed, and it was replaced with a metal one in November 2010, shortly before his symptoms began. So Dr. Schaefer tested the man’s cobalt level and discovered it was a thousand times the level considered normal.

A scan showed the metal in his hip was eroded. The reason, Dr. Schaefer speculated, was that when the man’s doctor removed the broken ceramic hip, he inadvertently left behind tiny particles of ceramic. Those particles, Dr. Schaefer said, acted like sandpaper: “You destroy the metal part with each movement.”

The man had his metal hip replaced with another ceramic one, after which his cobalt level plunged. His heart function improved, but he still needed a defibrillator implanted. His fever and esophagus problems went away. But his hearing and eyesight barely got any better.

Needless to say, the doctors in the other case, published in The New England Journal of Medicine, had not seen that episode of “House.”

The patient, a woman in Denver who asked not to be named to protect her privacy, said she began feeling ill on a vacation in Hawaii a few years ago.

“I was tired all the time,” she said. When she returned from her travels, she discovered she had gained 10 pounds on her 4-foot-10, 95-pound frame, for no apparent reason. Her abdomen was swollen, as were her arms and legs.

Her doctor ordered a CT scan, which showed fluid accumulating around her heart. He drained the fluid, but she still felt ill. Normally, someone with such a condition, cardiomyopathy, has an enlarged heart, but hers was a normal size.

“It was kind of a puzzle to my first cardiologist,” she said.
By 2011, her heart was failing. She went to the Anschutz Medical Campus of the University of Colorado, Denver, where her doctor, Larry A. Allen, a heart failure and transplant specialist, confessed he was baffled.

“We did a work-up looking at possible causes and even rare causes,” he said. “Nothing showed up.”
On Sept. 10, 2011, she underwent a heart transplant.
Sometime later, the orthopedist who had replaced her hips with metal implants took some routine blood tests and found something curious. Her cobalt level was more than 300 times normal. Cobalt poisoning can seriously damage organs, particularly the heart. The cause of her problems was suddenly clear.

About a year after her heart transplant, she had both artificial hips replaced with ones that had a polyethylene liner. Her postoperative course was rocky, but her cobalt level declined.
“I have much of my old energy back,” she said in an interview.

In their article describing the case, Dr. Allen and his colleagues wrote that cobalt poisoning was first described in the 1960s in people who had been drinking beer that had foam stabilizers that contained cobalt.

But its link to metal-on-metal hip implants leaves questions, they said. Their patient had nothing obviously wrong with her prosthetic hips. And, Dr. Allen said, “literally tens of thousands of people had these hips without her problems.”

But Dr. Allen said the patient’s case was a good reminder. However rare cobalt poisoning might be, it is something to consider when people with metal-on-metal hip implants have symptoms suggestive of it.

And, yes, he said, maybe if he had just seen Dr. House in action he would have considered it.
“Unfortunately,” he said, “I have seen about two half-episodes of ‘House.’ ”

Judge Approves $56 Million Biomet Metal Hip Settlement

Walter Eisner • Wed, February 5th, 2014

Orthopedics This Week

A federal judge approved settlement of Biomet, Inc.’s metal-on-metal hip lawsuits on February 3, 2014. The company now joins Johnson & Johnson’s (J&J) DePuy Synthes Companies and Stryker Corporation in announcing some settlements of consolidated lawsuits.

M2a Magnum System
The cases in Biomet’s litigation primarily involved alleged defects in Biomet’s M2a Magnum system of hip implant products. Plaintiffs’ claims focused upon the metal-on-metal design of the system and the alleged propensity of the devices to generate high levels of metal ions, causing metallosis in the surrounding tissue, and/or early failure.

Almost 900 cases had been filed in Indiana federal court against Biomet. According to a Scheduling Order issued on December 10, 2013, U.S. District Judge Robert Miller had directed parties to choose three cases as trial candidates by February 7, 2014.

$56 Million for Patients and Lawyers
Reuters reported that the company will pay at least $56 million in the settlement. That’s far less than the $2.5 billion-plus settlement agreed to by J&J or the limited settlement of four Stryker cases in New Jersey at the beginning of December.

As part of the settlement, Reuters reports that Biomet will deposit $50 million into an escrow account and another $6 million into an attorney fee fund. The agreement extends to all pending cases, and any future lawsuit filed in a federal court on or before April 15, 2014.
Plaintiffs who have received a Biomet M2a 38 or M2a Magnum hip replacement system as part of an initial hip replacement that was rectified more than 180 days after it was implanted shall, reportedly, receive a base award of $200,000.

According to Reuters, Biomet maintains that the injuries, losses and damages were not due to its hip implants. The company issued a press release saying it is pleased to have reached this settlement: “Biomet appreciates the guidance provided by Judge Miller to bring this litigation to an expeditious and efficient resolution.”

Biomet Settlement for Metal on Metal Hip Cases

 Shezad Malik MD JD
February 4, 2014 8:08 PM

Biomet Orthopedics the manufacturer of a line of metal on  metal hips, announced a global settlement late yesterday, involving the hundreds of defective hip claims.
The agreement settles Biomet M2a Magnum hip lawsuits brought in the federal court system. Biomet agreed to pay $56 million to resolve lawsuits alleging that design problems with the metal-on-metal implant caused patients to undergo hip revision surgery.

1,000 Biomet Defective Hip Claims
There are about 1,000 product liability lawsuits pending against Biomet in the federal court system. The lawsuits allege that folks experienced early failure and elevated metal ion poisoning known as metallosis, with Biomet M2a 38 or Biomet M2a Magnum hip replacements. Unfortunately many patients had to undergo painful revisions and lengthy rehabilitation.

Biomet Federal MDL Settlement
The federal litigation has been centralized and coordinated in the U.S. District Court for the Northern District of Indiana as part of an MDL, or Multidistrict Litigation.
According to Judge Miller,  who is coordinating the MDL, a settlement agreement has been reached to resolve all cases where folks have required revision surgery. Biomet has agreed to pay a base amount of $200,000 to each claimant, with other clinical factors affecting the individual allocation for each case.

Biomet Settlement Inclusion Criteria
The Biomet hip settlement will apply to each case filed on or before April 15, 2014. plaintiffs who have not undergone revision surgery are excluded from the settlement. But, if those patients do get their implants removed, they may then be eligible to take part in the settlement agreement.
There at least 237 non-revision cases currently pending in the MDL, according to court documents

Stryker Rejuvenate Defective Metal Hips Continue to Settle

Posted by Shezad Malik MD JD
January 31, 2014 8:49 PM

1,200 Stryker Hip Lawsuits
There are about 1,200 defective product liability hip lawsuits filed by folks injured after receiving a Stryker Rejuvenate or ABG II modular hip implant. These Stryker hips were recalled in July 2012, after medical reports revealed that the metal on metal design was subject to early failure within a few years.

Federal Minnesota MDL
There are about 600 cases pending in the U.S. District Court for the District of Minnesota, the federal lawsuits are centralized for pretrial proceedings before U.S. District Judge Donovan Frank as part of an MDL, or Multidistrict Litigation.

New Jersey State MCL
There are about 650 cases pending in New Jersey state court. The New Jersey litigation has also been centralized for pretrial proceedings, consolidated before Judge Brian R. Martinotti as part of an MCL, or MultiCounty Litigation.
Judge Martinotti has established a mediation process last year in the New Jersey litigation. In phase 1 of Stryker Rejuvenate mediation, a group of 10 cases were selected for early settlement negotiations.

New Jersey Mediation Process
Judge Martinotti is starting the process for a “Phase 2”, ordering the parties to submit a list of cases that will be eligible for this second round of mediation by February 4. The Court will then announce the final selections by February 11. Those mediations will be scheduled for dates in the second half of March and April 2014.

Scope of Stryker Problem
Before the Stryker Rejuvenate and ABG II implant worldwide recall in July 2012, an estimated 20,000 components were sold. As Stryker hips continue to fail, it is expected that several thousand cases will be brought in state and federal courts throughout the United States.

What is Wrong with Stryker Hips?
The Stryker Rejuvenate and ABG II contain a modular neck-stems, which consists of two pieces that fit inside each other to allow the surgeon to customize the length of the femoral component. The design causes metallosis from the release of metal debris as the chromium-cobalt neck grinds against the titanium femoral stem.
Although hip replacements are expected to last 15 to 20 years, the Stryker Rejuvenate recall was issued less than two years after the design was introduced.

Pinnacle hip preps for bellweather trials

Thousands of DePuy Pinnacle hip lawsuits ( involving a metal-on-metal version of the Pinnacle Hip Replacement System continue to move forward in U.S. District Court, Northern District of Texas, Bernstein Liebhard LLP reports. According to an Order issued on January 23, 2014, the Court will convene a conference on March 4, 2014 at 2:30 p.m., CST. At that time, preparations for the proceeding’s bellwether trials, as well as any outstanding discovery issues, will be discussed. (In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Product Liability Litigation, MDL No. 2244)

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