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Biomet Hip Replacements

In September 2001, the Food and Drug Administration (FDA) announced that Biomet and seven other U.S. medical devices firms would recall hip implants because of problems with a component that can fracture and require surgical replacement. The faulty component is the zirconia ceramic femoral heads, which is the ball portion of an artificial hip used in hip replacement surgery.

St. Gobain Desmarquest of France manufactured the zirconia ceramic femoral head. This femoral head was used in hip replacement products for Biomet, Apex Surgical LLC, DePuy Orthopedics Inc., Encore Orthopedics Inc., Osteoimplant Technology Inc., Smith & Nephew Inc., Stryker Howmedica Osteonics, and Zimmer Inc.

Symptoms of a fractured zirconia ceramic femoral head include hip pain, a sensation of grinding, or limitation of motion. The fracture is sometimes preceded by an audible pop. The at-risk hips tend to break between 19 and 28 months after they have been implanted.

It is estimated that six percent of the 150,000 to 200,000 persons that undergo hip replacement surgery each year receive an artificial hip containing the zirconia ceramic femoral head. The recall applies to zirconia ceramic femoral heads manufactured since January 1998.
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