September 17, 2001
Recall of Zirconia Ceramic Femoral Heads for Hip Implants
- The FDA is announcing a voluntary recall of the unimplanted inventory of
nine batches of zirconia ceramic femoral heads manufactured by a French
manufacturer, Saint Gobain Advanced Ceramics Desmarquest (St. Gobain
Desmarquest), and by U.S. manufacturers that have included these components
in their hip prostheses. The component is the "ball" portion of the hip
prosthesis that connects the femoral stem to the pelvis.
St. Gobain Desmarquest recalls 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
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.