Zimmer Hip Replacement Problems As FDA Deadline Passes
Twenty-one orthopedic device manufacturers were given until June 6, 2011 to submit plans to the FDA about how they will monitor the post-implant performance of their metal-on-metal hip replacement systems.
Several days after deadline, no details have emerged about how orthopedic giants such as Zimmer will study Zimmer hip replacement problems.
Zimmer Durom Cup failure rates
Zimmer’s Durom Cup is one of several metal-on-metal devices implicated in a high rate of hip replacement failure and complications such as metallosis and dislocation, some requiring hip revision surgery. Several plaintiffs have filed a Zimmer hip implant lawsuit over the Durom Cup, just as thousands have filed litigation involving DePuy Orthopaedics’ ASR, a hip system implanted in 93,000 people worldwide and recalled last year.
Metal-on-metal hip replacement failures force FDA to act
The high rate of complications and hip implant failure involving metal-on-metal systems –which involve two interlocking metal parts: the acetabular component and the femoral component – compelled the FDA to act on an industry that many say suffers from a lack of regulation.
In the United States there is no official joint registry to serve as a database for orthopedic success stories and failures.
Further complicating the picture is the controversial 510(k) premarket notification program, which the FDA uses to quickly clear orthopedic devices based on their similarity to previously approved devices. Both the Durom Cup and the DePuy ASR were cleared through the 510(k) program. Many believe the shortcut is responsible for DePuy and Zimmer hip replacement problems.
Zimmer Hip replacement lawsuits
It may be several months or even a year before the 21 orthopedic companies give the FDA the information it requests. As the bureaucracy lurches forward, a number of hip recipients have taken matters into their own hands and hired a Zimmer Hip lawyer. These Durom Cup recipients have filed their own Zimmer hip implant lawsuit, which were consolidated in a New Jersey court. Hundreds of DePuy ASR lawsuits are consolidated in an Ohio court.
Zimmer Hip settlements
It is unclear when and if any of the suits will ever reach trial. Already, Zimmer has paid out millions in settlements to Durom Cup recipients who experienced Zimmer hip replacement problems. DePuy has set aside nearly $1 billion to compensate ASR recipients.
It’s unclear if either defendant is ready to fight hip claims in court, much less release real statistics on hip replacement failure.