Saturday, April 6, 2013

Boynton Beach orthopedic surgeon removes recalled artifical hips; ‘This is really wearing us down’

By Stacey Singer

Palm Beach Post Staff Writer
                           
No surgeon wants to undo a major operation, especially not one who spends his days trying to restore worn-out, arthritic, pain-riddled hips and knees.

But for the past 12 months, week after week, that’s what Boynton Beach orthopedic surgeon Dr. Robert Zann has been doing – removing artificial hips that were supposed to have restored quality of life to his patients, not taken it away.

Boynton Beach orthopedic surgeon removes recalled artifical hips; ‘This is really wearing us down’ photo
Dr. Robert Zann displays a Stryker modular hip system his office at Orthopaedic Surgery Associates in Boynton Beach. (Bruce R. Bennett/The Palm Beach Post)
Boynton Beach orthopedic surgeon removes recalled artifical hips; ‘This is really wearing us down’ photo
Dr. Robert Zann (Bruce R. Bennett/The Palm Beach Post)
Palm Beach Post Staff Writer


For more than two years, Zann said he installed the now-recalled Stryker Rejuvenate and ABGII modular hip systems, believing he was using the best possible medical device. In all, he implanted 400 of the joints. Since then, he has watched with growing alarm as the patients, one by one, young and old, are developing measurable metal contamination on blood tests, and painful, fluid-filled tumors around their artificial joints.

Zann has removed 100 of the failed systems in the past year. He expects to take out at least 100 more before he’s finished. If his prediction holds true, the Stryker Rejuvenate and ABGII hip prosthesis recall will represent one of the more serious medical device failures in recent history, with an extraordinary revision rate that could meet or pass 50 percent since it was introduced to the market in 2009.

“When I start operating it is the same mess in them, every single one,” Zann said. There’s a high-pressure fibrous tumor-like pocket so full of fluid that it pops when he cuts into it. There is inflamed muscle, and white milky fluid around the joint. The operation to remove a fixed joint is arduous for doctor as well as patient.

“We are exhausted right now. This is wearing us down. This is really wearing us down.”
For his patients, it’s worse. Revised artificial hips often perform worse than a first prosthetic, surgeons say, because of issues with bone loss and fit.

Boynton Beach retiree Burt Weisberg had his Stryker Rejuvenate hip stem revised last June.
Since that second hip surgery, the replaced joint has dislocated twice, once while he was riding his bike, another time while he was tying his shoes. It’s excruciatingly painful, requiring an ambulance trip to the emergency room each time, he said.

“I live everyday with the knowledge that if I dislocate again, they are going to go back and do more surgery on me,” Weisberg said. Before his first hip surgery, he was active. Now? “I can’t bowl anymore. I’m afraid to play volleyball. Even when I play golf every swing I take I’m afraid.”

Weisberg has hired an attorney, C. Calvin Warriner with Searcy Denney Scarola Barnhart & Shipley of West Palm Beach. Warriner said he’s representing more than 300 clients across the nation.
More than 80 lawsuits have been filed in New Jersey’s Bergen County, where Stryker is based. Another 30 lawsuits have been filed in federal court.

That’s where Joseph A. Osborne, of Babbitt, Johnson, Osborne & Le Clainche has filed most suits on behalf of his approximately 100 clients.

“We have some doctors who believe the revision rate will be 70, 80, 90 percent,” Osborne said.
Both attorneys believe the doctors who installed the joints have been victimized along with the patients.

“I feel really bad for these doctors. This has crushed their reputations,” Warriner said.
In an advisory to investors, Stryker has predicted its liability could cost between $190 million and $390 million. More than 30,000 of the hip systems have been installed worldwide, 20,000 of them in U.S. patients.

Zann said one of every five surgeries he performs now is removal of the recalled Stryker hip systems. His office is inundated with patients responding to warning letters he has sent, asking them to come in for metal testing and an MRI.

“This has been the worst year of my life,” Zann said. “I’m so frustrated I can’t tell you.”

The Stryker modular joints were supposed to be a major advance, a fixed titanium-alloy stem with chromium cobalt necks of varying size and shape, designed to give surgeons maximum flexibility to obtain the best fit. But soon after getting their new hip, some patients began developing painful, fluid-filled tumors next to their new joints. Tests are showing that metal ions are corroding into the tissue around the joints, and getting into the patients’ bloodstream, sometimes at toxic levels.

A spokeswoman for Stryker in Mahwah, N.J., Jeanine Guilfoyle, wrote in emailed answers to questions from The Palm Beach Post that its patients’ health and well-being is and has been Stryker’s top priority. The firm has hired Broadspire Services Inc., a third-party claims payment firm, to write checks for patients’ medical bills, and some related expenses.

However, she couldn’t offer concrete answers to the questions patients are asking most: How much cobalt is dangerous? How long will the cobalt stay in my system after the joint is out? Will it cause cancer?

“We continue to monitor this issue and collect and assess data as we work with the medical community to better understand this matter,” Guilfoyle wrote.

Data has been a problem. In Australia, Sweden and Great Britain, medical devices are tracked in mandatory national registries, allowing failures to be spotted early in the life of a product, sparing lives and trauma. The Australian registry first brought the Stryker problem to light.

Here in the United States, a voluntary effort supported by medical device makers, is in its infancy. It has collected about 30,000 records from about 116 hospitals, but that’s not enough to analyze and draw conclusions, said Jeffrey Knezovich, executive director of the American Joint Replacement Registry in Rosemont, Ill. His database will have to hit 100,000 records to become useful for patients and medical professionals.

No Florida hospitals have yet signed on to connect and send data to the group, he said. Perhaps the latest recall will spur hospital executives to begin sharing data, he said.

For now, Zann feels he’s having to blaze his own trail, finding out by trial and error which patients need immediate revision surgery and which ones can wait; what surgical techniques are most successful, and which ones do most damage. He has found that a discontinued burr, a slender toothpick-sized drill bit, is the best tool for the job, and that he can drill around the metal and then slide the stem out rather than slicing into the bone and wiring it back together. So at his request, Stryker is manufacturing the implement again, he said.

He’s now teaching other surgeons how to do the procedure, and telling them they must do it, and quickly, before there’s too much damage to surrounding tissues.

“The worst thing in the world for a surgeon to admit to is failure. Do you know how bad that makes me feel?” Zann said. He’s now giving his patients information about alternative treatments, like spa-style salt baths and cilantro supplements, said to reduce metal toxicity. It seems to help a little, but it’s no substitute for removing the joint. And so he keeps operating.

“If someone comes here, they are on crutches, they have a walker, they can’t function? Something is wrong with that hip. These are human beings, they are suffering, you can’t leave them like that,” he said. “I think about my patients night and day.”

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