The U.S. Food and Drug Administration had announced the second major recall of hip implants within the past year. On August 14, 2001, French manufacturer St. Gobain Desmarquest voluntarily recalled nine batches of zirconia ceramic femoral heads, the "ball" portion of the hip prosthesis. The potentially defective components were manufactured since early 1998 when St. Gobain Desmarquest changed part of its manufacturing process. One report suggests that the ceramic was left more fragile following a change in the heating process during manufacturing.
The recall of the zirconia ceramic femoral heads occurred following a higher than expected fracture rate in some patients, 13 to 27 months post-op. The FDA reported 14 cases of Americans who experienced fracture of the recalled hip implant.
The zirconia ceramic components were distributed by more than 51 companies worldwide. Eight U.S. companies used St. Gobain Desmarquest zirconia ceramic femoral heads and participated in the recall:
- Apex Surgical, LLC (Lakeville, Massachusetts)
- Biomet, Inc., (Warsaw, Indiana)
- DePuy Orthopaedics, Inc. (Warsaw, Indiana)
- Encore Orthopaedics, Inc. (Austin, Texas)
- Osteoimplant Technology Inc. (Hunt Valley, Maryland)
- Smith & Nephew, Inc. (Memphis, Tennessee)
- Stryker Howmedica Osteonics (Allendale, NJ)
- Zimmer, Inc. (Warsaw, Indiana)
It was estimated that between 150,000 and 200,000 hip implants were performed each year in the United States int he early 2000's. Hip implants with zirconia ceramic femoral heads were used in less than 6 percent of hip replacement surgeries performed in the United States.