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Medical Device Recalls Recall of Zirconia Ceramic Femoral Heads for Hip Implants

On Tuesday, August 14, 2001, St. Gobain Desmarquest recalled nine specific production batches of its zirconia ceramic femoral heads, which include some lots sold in the United States. As a result, most orthopedic companies have either recalled or are in the process of recalling zirconia ceramic femoral heads manufactured by the French company. The zirconia ceramic components are distributed worldwide by more than 51 companies. U.S. companies estimate that zirconia ceramic femoral heads are used in less than 6% of hip implant procedures in the United States. About 150,000 to 200,000 hip prostheses are implanted into U.S. patients each year.

This recall follows recent action by the French Agency for the Medical Safety of Health Products (AFSSAPS) and the United Kingdom Medical Devices Agency suspending sales of all St. Gobain Desmarquest-manufactured zirconia ceramic heads made after a manufacturing process change in 1998. A letter published by AFSSAPS cited the higher than expected fracture rate in some of the product produced by St. Gobain Desmarquest, with several possible reasons for the increased number of fractures.
FDA is working with the U.S. industries, with Saint Gobain Desmarquest, and with the foreign regulatory agencies to help resolve this issue.

The orthopedic industry is working with various regulatory agencies around the world to determine whether and to what extent there are any performance issues with other production batches of zirconia heads manufactured by St. Gobain Desmarquest. The U.S. companies that are recalling the St. Gobain Desmarquest components are:

• Apex Surgical, LLC (Lakeville, Mass.)
• Biomet, Inc. (Warsaw, Ind.)
• DePuy Orthopaedics, Inc. (Warsaw, Ind.)
• Encore Orthopedics, Inc. (Austin, Tex.)
• Osteoimplant Technology Inc. (OTI) (Hunt Valley, Md.)
• Smith & Nephew, Inc. (Memphis, Tenn.)
• Stryker Howmedica Osteonics (Allendale, NJ)
• Zimmer, Inc. (Warsaw, Ind.)
  

Meanwhile, surgeons should not implant artificial hips with the St. Gobain Desmarquest zirconia ceramic heads manufactured since the process change in 1998.

Important points to consider:

• The recall applies only to unimplanted zirconia ceramic femoral heads.
• No metal or alumina femoral heads are involved in the recall. There is no known concern for any metal or alumina femoral heads.
• Zirconia ceramic femoral heads manufactured before 1998 are not being recalled.
• Although the failure rate is higher than expected, not all zirconia ceramic femoral heads made by St. Gobain Desmarquest after 1998 will fail. It is important to note, therefore, that there are patients who have these zirconia ceramic femoral heads made after 1998 who will not experience failure of their implants.

For patients who already have this implant:

• FDA is not recommending surgery to replace any hip implants that have not fractured or are not causing problems.
• There are no tests that can predict which patients will experience failure of their hip implants because of defective zirconia ceramic femoral heads.
• Physicians will likely choose to monitor the performance of the implant more closely as a result of the ongoing issue. Physicians should watch for patients complaining of the sudden onset of pain in the implanted hip joint. Patients may report that they heard a 'pop' from their hip just before the onset of pain
• Patients should contact their surgeons with any questions or concerns.
  

FDA Contact: Consumer Relations Staff, CDRH, at 888-Info FDA or 888-453-6332.

Updated September 13, 2001

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