In September 2001, the FDA announced that eight U.S. companies
are recalling some of their hip implants due to potential defects.
The component made by a French manufacturer, St. Gobain
Desmarquest, is a zirconia ceramic femoral head, the ball portion
of the hip prosthesis that connects the femoral stem to the pelvis.
The femoral head was recalled because it was fracturing at a
higher rate than expected in some patients 13 to 27 months after
implantation.St. Gobain Desmarquest distributed zirconia ceramic
femoral heads to the following eight U.S. Companies who are
participating in the recall:
-Apex Surgical, LLC of Lakeville, Massachusetts
-Biomet, Inc. of Warsaw, Indiana
-DePuy Orthopedics, Inc. of Warsaw, Indiana
-Encore Orthopedics of Austin, Texas
-Osteoimplant Technology, Inc. of Hunt Valley, Maryland
-Smith & Nephew, Inc. of Memphis, Tennessee
-Styker Howmedica Osteonics of Allendale, New Jersey
-Zimmer, Inc. of Warsaw, Indiana
The nine potentially defective batches of zirconia ceramic femoral
heads being recalled were manufactured after the beginning of 1998
when the French manufacturer changed its manufacturing process.
Of the 150,000 to 200,000 hip implants that are performed in the
U.S., less than six percent involve zirconia ceramic femoral heads.
The signs of a fractured implant involve sudden pain in the
implanted hip joint, sometimes preceded by an audible "pop"
the hip before it begins to hurt. Revision surgery is necessary to
replace problem free implants because not all zirconia ceramic
femoral heads are expected to cause problems. Unfortunately,
there is no way to test which patients will experience hip implant
failures because of defects in these femoral heads.
If you suspect you received this type of hip implant you should
contact your physician so they may monitor the performance of the
implant more closely for potential problems.