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Biomet Artificial Hips

In February of 2001, the US Food and Drug Administration announced that Biomet, a US manufacturer of artificial hip joints, made a voluntary recall of its hip replacement systems following the discovery of a defect in the zirconia ceramic femoral head portion. The ceramic femoral head component was produced by the French manufacturer Saint Gobain Desmarquest, which also sold and distributed the femoral heads to the worldwide orthopedic industry. This recall applies to 9 lots of the ceramic femoral head components known as Prozyr® Zirconia Heads which were produced from January 1998 to September 1999, at a time when Saint Gobain Desmarquest changed its manufacturing process.

Biomet recalled their defective product once it was determined that the joint face was vulnerable to fracture at a higher than acceptable rate, and at premature dates, causing total failures of the hip implant systems within 13 to 28 months. Other makers of hip implants including DePuy Orthopedics, Stryker Howmedica Osteonics, Encore Orthopedics, Smith & Nephew Inc., Osteoimplant Technology, Apex Surgical, and Zimmer Inc. also used this defective component in their hip replacement devices. Since this particular recall only applies to ceramic femoral heads produced since the early 1998, it is important to determine that the batch number on the recalled ceramic femoral head batches has the prefix "TH." This recall does not affect any femoral heads made of alumina ceramic.

Following Biomet's initial recall, all of the other manufacturers who used the defective head followed suit and withdrew their products from the market, saying that the product could fail and fracture, after which the patient must undergo a replacement and revision surgery. The FDA has asserted that the ball portion of these artificial hip joints connecting the pelvis and the femoral stem become unstable and thus cause fracture. Patients have reported hearing a "pop" sound from their hip region immediately before the device failed, after which they experienced excruciating groin and hip pains.

The symptoms of a Biomet hip replacement failure may include groin pains, a grinding sensation in region of the hip, an audible "pop" sound after which range of movement decreases and pain increases.

It is reported that more than 150,000 to 200,000 patients undergo hip replacement surgery in the United States every year. Six percent of patients received a defective hip implant. If you or a loved one has had a surgery to implant a Biomet hip, and are currently experiencing difficulty, you can call our offices at 503.452.5858 or toll-free 800.255.1996 for a no cost consultation. Attorney Jeffrey Bowersox will be glad to discuss your options to gain relief.

 


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