This article is part of the Arthritis Archives.
Dateline: September 20, 2001
Second Major Recall
The U.S. Food and Drug Administration has announced the second major recall of hip implants within the past year. On August 14, 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 reports 14 cases of Americans who experienced fracture of the recalled hip implant.
The zirconia ceramic components are distributed by more than 51 companies worldwide. Eight U.S. companies use St. Gobain Desmarquest zirconia ceramic femoral heads and are participating 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 is estimated that between 150,000 and 200,000 hip implants are performed each year in the United States. Hip implants with zirconia ceramic femoral heads are used in less than 6 percent of hip replacement surgeries performed in the United States. No metal or alumina femoral heads are involved in the recall. Zirconia ceramic femoral heads manufactured prior to 1998 are not part of the recall.
Last December, Sulzer Medica announced a voluntary recall of its hip implants, also due to a problem during the manufacturing process.
Sources: Hip Implants Being Recalled; Potential Fracture Problem, FDA Talk Paper, 09/14/01; Recall of Zirconia Ceramic Femoral Heads for Hip Implants, FDA.gov, 09/13/01; French medical device maker recalls artificial hip component, ReutersHealth, 09/14/01; Artificial Hips Are Being Recalled, Associated Press, 09/15/01
First published: 9/20/2001