Eight U.S. companies will voluntarily recall certain hip implants because
they were discovered to fracture at a higher rate than expected in some
patients, the FDA announced Friday.
The component responsible for the recall is the zirconia ceramic femoral
head, which is manufactured by St. Gobain Desmarquest. The France-based
company recalled nine batches of the zirconia ceramic femoral heads with the
prefix TH, which have been manufactured since early 1998, on Aug. 14. The
zirconia ceramic femoral head is the ball portion of the hip prosthesis that
connects the femoral stem to the pelvis. St. Gobain Desmarquest distributes
zirconia and alumina ceramic femoral heads worldwide to most of the
orthopedic industry.
The U.S. companies that use the zirconia femoral heads are APEX SURGICAL LLC
(Lakeville, MA); BIOMET INC. (Warsaw, IN); DEPUY ORTHOPAEDICS INC. (Warsaw,
IN); ENCORE ORTHOPEDICS INC. (Austin, TX); OSTEOIMPLANT TECHNOLOGY INC.
(Hunt Valley, MD); SMITH & NEPHEW INC. (Memphis, TN); STRYKER HOWMEDICA
OSTEONICS (Allendale, NJ); and ZIMMER INC. (Warsaw, IN).
The companies estimate that hip implants with zirconia ceramic femoral heads
are used in less than 6 percent of hip implant procedures in the United
States. About 150,000 to 200,000 hip implants are performed annually in the
United States.
According to the FDA, the patient usually feels a sudden pain when the
fracture of the implant occurs and an audible sound from the hip might
precede the pain. If a hip implant fractures, replacement surgery is
necessary. However, the companies do not expect all zirconia ceramic femoral
heads to fail. For that reason, the FDA said in a statement that it is not
recommending surgery to replace hip implants that have not fractured or are
not causing problems.
The recall of the hip implants is the second major hip implant recall in the
past year. As reported by Medical Industry Today, SULZER MEDICA (Winterthur,
Switzerland) announced a voluntary recall of certain of its hip implants
last December due to a lubricant residue on the implant that prevented it
from bonding with the hipbone. Like Desmarquest, Sulzer's problem was traced
to a change in a manufacturing process.
A federal judge gave preliminary approval this month to Sulzer's proposed
$800 million class action settlement offer for lawsuits over the hip
implants that were contaminated with machine oil, as reported. However, an
immediate appeal has put the settlement into question.
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09/17/01
