Due Date Approaches for Zimmer Hip Study Proposal
June 6, 2011 marks a date that many a Zimmer hip lawyer has an eye on: On this day, 20 U.S. manufacturers of artificial hips must provide the FDA with their proposed plans for studying the post-implant performance of their devices. After numerous reports of prosthetic malfunctions, including Zimmer hip replacement problems, the FDA took the uncommon step of mandating that device makers collect official data on the failure rates, and associated side effects, of their artificial hip models.
Zimmer hip lawsuits filed over device complications
The FDA had previously drawn criticism in some medical circles for its blanket policy of approving orthopedic hip replacement systems for the market without first requiring clinical trials. The metal-on-metal hip replacement device known as the Durom Cup, distributed by Zimmer Holdings, was passed by the FDA and first issued to the market in 2006. Quickly, evidence of Zimmer hip replacement problems began to mount, leading to one Zimmer hip implant lawsuit after another.
Zimmer hip recall
Though the FDA took no action, Zimmer itself temporarily pulled the device from the market in 2008, after a study revealed that as many as 8% of surgically installed Durom Cups needed removal after only two years. Insisting that Zimmer hip replacement problems were not the result of a defect in the device, but of faulty technique on the part of underprepared surgeons, Zimmer eventually re-marketed the Durom Cup with surgical instructions that were more precise.
Complaints about the Zimmer hip replacement device did not abate, however. Both before and after the voluntary recall, implant patients reported side effects such as device dislocation, severe pain, stiffness, and perhaps most unnerving of all, metal poisoning resulting from metal shavings from the implant being absorbed into body tissue and the bloodstream.
Hip metal poisoning afflicted some recipients
The increasing frequency with which metallic shavings have caused soft tissue damage in prosthetic recipients (along with the many Zimmer hip implant lawsuits that have generated from it), seems to have provoked the FDA into action. Device makers, including Zimmer, will not only have to report the rates of revision surgery, but will also have to take blood samples from patients that test for excessive levels of metal ions.
The results of these artificial hip studies are expected to have a huge impact on Zimmer hip implant lawsuits. But when will the results from these tests ultimately be reported to the FDA and the public? On June 6, the answer may very well be revealed.