Law Firm Investigates Faulty Implants

SAN FRANCISCO--(BUSINESS WIRE)--May 31, 2001

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The national law firm of Lieff Cabraser Heimann & Bernstein, LLP announced today that at the request of patients with faulty Sulzer knee implants it has expanded its investigation of Sulzer Medica and its United States subsidiary Sulzer Orthopedics, Inc., to include Sulzer's manufacturing, distribution and sale of knee implants.

• Background – Sulzer's Earlier Hip Replacement Recall

Headquartered in Switzerland, Sulzer Medica (NYSE:SM - news) develops, manufactures and markets medical devices and biological products for cardiovascular and orthopedic markets worldwide. On December 8, 2000, Sulzer issued a press release announcing the recall of its Inter-Op™ Acetabular Shells. The shells were primarily sold in the U.S. after October, 1999, with a smaller number of lots sold after July, 1997. Sulzer estimated 17,500 persons, most residing in the United States, had received the recalled shells.

When it announced the hip recall, Sulzer stated that the products had "an unacceptable level of mineral oil-based lubricant on the product." Specifically, an oily residue was found on the exterior porous surface of certain Sulzer Inter-Op™ hip shells. According to later press reports, the oil was intended to lubricate tooling machines that produced the hip shells. However, the machining oil seeped into coolant that was sprayed on the hip shells during the manufacturing process, and an oily residue remained on the shells when implanted in patients.

For many patients, the machining oil has inhibited the implant from properly bonding with the pelvis. The result is that the patient often experiences extreme pain and a lack of mobility, requiring additional surgery (known as revision surgery). As described by Californian Cherie Lewis, who received a defective Sulzer hip implant in October 2000, the pain from the loose implant was "a 12 on a scale of 1 to 10."

To date, almost 1,700 Sulzer hip recipients have had to undergo revision surgery. How many Sulzer hip implants in the remaining 15,800 persons who received the recalled product will actually fail, or are susceptible to failure from normal usage, remains unknown. Some physicians who used Sulzer hip implants have found that a substantial percentage of their patients require revision surgery, including one orthopedic surgeon in Oakland, California who expects to do corrective surgery on half of his 250 patients with Sulzer hip implants.