Hundreds of artificial hips are being recalled because one
piece -- the joint ball -- is made of a ceramic that may suddenly crack.
The Food and Drug Administration announced the recall Friday, warning
surgeons not to use the affected implants -- and patients to call their
doctors if they experience symptoms suggesting the joint has cracked.
The FDA has at least 14 reports so far of Americans in whom the recalled
hips have broken.
It's the second major recall of artificial hips in the past year.
Sulzer Medica, based in Austin, recalled thousands of its artificial hips in
December, after a manufacturing change left an oily residue on some that
prevented the new joint from bonding with patients' bones. A court is now
considering a proposed $700 million class-action settlement for recipients
of those joints.
Patients shouldn't panic: Not all the recalled hips will break, and there's
no need for more surgery unless one does. But there's also no way to predict
which hip will fracture.
Patients should "be aware this increased risk exists," said FDA medical
officer Dr. Dan Schultz. "If they have any symptoms whatsoever, they need to
get in to see their physician as quickly as possible. Don't assume ... it's
something that is just going to go away."
Symptoms include hip pain, a sensation of grinding or limitation of motion,
Schultz said. The fracture sometimes is preceded by an audible pop.
The at-risk hips tend to break between 19 and 28 months after they're
implanted, said FDA compliance officer Carol Fedorchak.
The French company St. Gobain Desmarquest recalled nine batches of its
ceramic femoral heads -- the ball portion of the hip implant -- that were
manufactured since early 1998.
The worst batch has an 8 percent breakage rate, well above the one-hundredth
of a percent breakage rate expected for such parts, Fedorchak said. The
other eight batches had a far lower breakage rate, but were being recalled
as a precaution.
Apparently, a change in the manufacturing's heating process left the ceramic
more fragile.
Eight U.S. makers of artificial hips use the French maker's ceramic part,
and they currently are pulling affected implants out of surgeons' offices,
including Encore Orthopedics of Austin.
09/14/01