Hip Replacement Recall

 

St. Gobain Hip Replacement Surgery Recall

A hip implant used in upto 9000 people was recalled on September 14, 2001. The implants contained a defective femoral head, made of ceramic. The recalled products are technically called Prozyr Zirconia Heads. The femoral head is the ball component of the ball and socket joint and many of these fracture at unacceptably high rates.   The serious problems involve an 8 percent breakage rate, as compared to the one-hundredth of a percent breakage rate usual for such parts.

The implants were made by St. Gobain Desmarquest, also called Saint Gobain Advanced Ceramics Desmarquest. However, most patients may be unaware of the recall because this is not the name of the distributor or medical device manufacturer whose implant they have. In many cases the head is only one of the components of the implant. More than 50 orthopedic implant device companies used these ceramic components manufactured by St. Gobain, of these several US companies are subject to the recall.

Below are seven of the companies that distributed these defective hips:

U.S. companies using these ceramic components include:
* Apex Surgical LLC
* Biomet, Inc.
* DePuy Orthopedics, Inc.
* Encore Orthopedics, Inc.
* Osteoimplant Technology, Inc.
* Smith & Nephew, Inc.
* Stryker Howmedica Osteonics
* Zimmer, Inc.

The hip defect is believed to be a result of a new manufacturing process that was used to create femoral head implant components between January 1998 and September 1999. The recall to nine lots of femoral head hip implant components made by St. Gobain during that timeframe. Hip implants made before 1998 are not involved.

Based on information from St. Gobain, Lawyers believe that about 9,051 femoral heads were defective, However, no knows how many have been surgically implanted into patients. At the beginning of 2002, St. Gobain reported 162 breakages of the ceramic heads, each of which required extensive revision surgery to remove and replace.

Patients with ceramic femoral head hip implants cannot predict when or if the hip will fail. According to Zimmer: "no tests that can predict which patients will experience failure of the defective zirconia ceramic femoral heads."

Generally signs of signs of a implant failure include hip joint pain, leg pain, inability to bear weight on the leg and start up pain which is experienced when attempting to stand or rise while seated.

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