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Texas Medical-Device Co. Faces Suit

Jun 14, 2001

Medical-device maker Sulzer Orthopedics, facing 700 lawsuits over a hip-replacement part it recalled last year, has been sued by a man who says his knee implant had the same defect.

Leroy Harp of Tulsa, Okla., sued Sulzer in March. His lawsuit is believed to be the only one involving a Sulzer knee, but attorneys representing hip-implant recipients said patients in other states are contacting lawyers and more lawsuits are expected, the Austin American-Statesman reported in Thursday's editions.

Until last month, Sulzer said its other products were manufactured differently than the hip part and were safe. Then, the company announced the knee implant might have the same defect as the hip part.

Sulzer spokesman Bill Miller said the company first received reports of potential problems with the knee in mid-January and learned soon after that one patient had an implant replaced.

By then, Sulzer had already changed the way it makes the implant, called a stemmed tibia baseplate.

The part had gone through some of the same manufacturing steps as the flawed hip part.

The company is investigating how patients are doing after knee surgery and has no plans to recall that part.

Sulzer wrote to surgeons on May 17 and publicly announced the potential problem on May 21. On May 30, Sulzer sent a ``special alert'' letter to physicians asking them to return for study any implants they had removed.

Sulzer also asked doctors to monitor patients and promised to reimburse patients who needed remedial surgery.

Nearly 17,500 patients received Sulzer hip implants, and about 1,800 have had them replaced, according to the company. By contrast, only 1,485 patients, 37 of them in Texas, received the knee implants.

Like the hip implant, the knee part has a porous coating that allows bonding with the patient's bone. Until December, both parts went through machining steps that left traces of oil, which prevented bonding in some patients.


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