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DEFECTIVE SULZER KNEE IMPLANTS
Sulzer sent a letter to physicians on May 17, 2001
indicating that they had received reports from orthopedic surgeons that
its knee implants were not properly bonding to the bone. On May 21, 2000, Sulzer issued a press release (full
text below) indicating that it had informed the Food and Drug Administration
of internal, ongoing investigations of a porous-coated tibial baseplate
that was manufactured from July to December of 2000.
The affected porous-coated tibial baseplates, which are no longer
on the market, were implanted in 1,485 patients, the vast majority of
them in the United States." Unlike when it recalled its
defective hip implants.
Despite this information, Sulzer
has not initiated a recall of the knee implants as they have done with
defective implants that they manufactured.
On June 18, 2001, Sulzer issued another press release
indicating that almost 1,600 patients have received the suspect knee implants,
and that at least 65 revision surgeries have been performed.
By October of 2001, Sulzer indicated that more than 400 revision
surgeries had been performed. Much
like the problems with Sulzer hip implants, the knee implants are suspected
to fail due to leaky mineral oil which does not allow the implant to seat
properly.
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