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Another Hip Implant Recall

8 U.S. companies affected by zirconia ceramic femoral heads recall

By

Updated May 25, 2006

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.

Companies Affected

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)

Key Points

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.

  • Not all zirconia ceramic femoral heads are expected to fail. The recall only applies to unimplanted zirconia ceramic femoral heads.
  • The FDA is not recommending surgery to replace hip implants that have not fractured or are not causing problems.
  • Sudden pain in the implanted hip joint often preceded by an audible "pop" often signal fracture of the defective component. Surgical correction is necessary if fracture does occur.
  • No test can be performed to predict which patients will experience fracture of their zirconia ceramic femoral head component.
  • Patients with the potentially defective implant should be monitored more closely by their physician.
  • Patients are being advised to contact their surgeons with any questions or concerns. The FDA can also be contacted for more information at 888-Info FDA.

    Last December, Sulzer Medica announced a voluntary recall of its hip implants, also due to a problem during the manufacturing process.

    Related Resources

  • Hip Pain / Hip Problems
  • Surgery For Arthritis
  • Osteoarthritis
  • Rheumatoid Arthritis or Osteoarthritis: Which is it?
  • 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

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