Sulzer's new problem: knee replacements

By J. NEALY-BROWN

© St. Petersburg Times,
published June 1, 2001

Only months after a medical device company recalled defective hip implants, it began telling doctors of a problem with knee replacements produced the same way.

Sulzer Orthopedic, which manufactures artificial joints, also expressed concern about having enough insurance to pay for all hip revision surgeries, now estimated at 1,700.

The problem that prompted the hip replacement recall, a residue of mineral oil, is not the same reason for the knee replacement alert, the company said.

In a letter mailed to doctors last month, Sulzer officials mentioned "unanticipated adverse clinical outcomes" with a part of the knee replacement system that has a porous coating.

Small amounts of oil residue were found on the replacement part, but "we met clinical standards," Sulzer spokesman Bill Miller said Thursday.

"It never was, or is, a situation such as existed with the hip, where you had an abundance of mineral oil," he said.

But Sulzer had marketing concerns and pulled the knee replacements off the market in March. The company still is investigating and urging doctors to monitor the nearly 1,500 patients who had the knee implant from July 2000 to December 2000.

In July, Sulzer changed the way it manufactured the knee replacement part, called the porous-coated stemmed tibia baseplate.

When the hip replacement concern surfaced, Sulzer stopped production and tested its products, according to the letter signed by Sulzer Orthopedic president Gary Sabins.

The baseplates, by comparison, were consistently clean, with only low levels of oil residue.

"Nevertheless, we changed the manufacturing process back to the original process," Sabins wrote in the letter.

Sulzer -- a subsidiary of Sulzer Medica, a multimillion-dollar international medical device company in Switzerland -- also took steps to correct the production of the 23,000 hip implants with an oil residue on the surface. The problem was caused by a manufacturing error at the plant in Austin, Texas.

The company later added two new cleaning steps and changed the sequence of the manufacturing.

At the time, Sulzer officials said no other products were affected.

"There's no problem right now that we know of, and the numbers are relatively small," he said. Of the nearly 1,500 knee replacement parts, about 1,300 of them are in the United States. The others are in Europe and Australia.

On the insurance warning, Miller said Sulzer issued an alert only because the company is publicly traded and required to make such disclosures.

"People shouldn't be worried that they're not going to be reimbursed," Miller said.

But lawyers representing hip patients in the Tampa Bay area say the latest news from Sulzer is an indication that the company has problems.

"From a quality assurance manufacturing standpoint . . . it suggests that they just don't know what they're doing," said Joseph H. Saunders, a lawyer in Pinellas Park who is representing patients who are suing over defective hip implants.

"It's kind of a sad commentary on this company's approach to manufacturing," a process that he called faulty and disorganized.

Saunders said he has been contacted by a Lakeland woman who has had problems with her knee replacement.

"The patients are all scared," said Dr. Michael Wasylik, chief of orthopedics at St. Joseph's Hospital in Tampa.

He said he has no patients who are affected but "every day I get a phone call."

"They're not having trouble, but they're afraid," said Wasylik, who temporarily stopped using Sulzer hip implants after the recall, but has since resumed their use.

He never stopped using the knee products, and tells his clients about what's happening.

Patients who are concerned can call their doctor or call Sulzer's patient line, 1-800-888-4676.

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