Artificial hip recall

FDA Consumer, Nov-Dec, 2001

Eight U.S. firms have voluntarily recalled some types of hip implants because they have a component that may crack. The affected component--the zirconia ceramic femoral head--is the ball portion of the prosthesis that connects the end of the large bone in the thigh to the pelvis.

The hip implant recall was initiated by French manufacturer St. Gobain Desmarquest in August because the femoral head was fracturing at a higher rate than expected in some patients 13 to 27 months after being implanted. St. Gobain Desmarquest distributes zirconia and alumina ceramic femoral heads worldwide to most of the orthopedic industry.

The French firm's recall applies to nine batches of zirconia ceramic femoral heads manufactured since early 1998, when St. Gobain Desmarquest changed its manufacturing process. No metal or alumina ceramic femoral heads are involved in the recall.

U.S. companies estimate that hip implants with zirconia ceramic femoral heads are used in less than 6 percent of hip implants in the United States. An estimated 150,000 to 200,000 hip implants are performed annually in this country.

People who have these hip implants should contact their surgeons with any concerns. Not all of the recalled hips are expected to fail, and the FDA is not recommending surgery to replace hip implants that are not causing problems. Physicians likely will choose to monitor the performance of the implant more closely as a result of the potential problem, according to the FDA.

Signs of fracture of the ceramic component may include a sudden pain in the implanted hip joint, sometimes preceded by an audible "pop" from the hip just before the onset of pain. No tests exist that can predict who will experience failure of their hip implants because of the defective component.

U.S. companies that use the St. Gobain Desmarquest zirconia ceramic femoral heads include: Apex Surgical LLC, Lakeville, Mass.; Biomet Inc., Warsaw, Ind.; DePuy Orthopaedics Inc., Warsaw, Ind.; Encore Orthopedics Inc., Austin, Texas; Osteoimplant Technology Inc. (OTI), Hunt Valley, Md.; Smith & Nephew Inc., Memphis, Tenn.; Stryker Howmedica Osteonics, Allendale, N.J.; and Zimmer Inc., Warsaw, Ind.

Further details on the recall are available on FDA's web site at www.fda.gov/cdrh/recalls/zirconiahip.html.>

COPYRIGHT 2001 U.S. Government Printing Office

COPYRIGHT 2008 Gale, Cengage Learning