A woman in Arizona has filed a defective product lawsuit against Wright Medical Inc. In the lawsuit, the woman claims the Profemur Z Hip Implant she received is defective. According to court documents, the woman received a Wright Profemur Z Hip Implant in 2006, only to have it removed three years later due to the implant failing.
Under ideal conditions, a hip implant should last for approximately fifteen years. Report data from the Australian National Joint Replacement Registry, the Wright Profemur femoral stem had a cumulative revision rate of 11.2% at three years.
According to court documents, the woman experienced considerable pain in her right hip. Medical evaluations and x-rays revealed that the acetabular cup had loosened and rotated almost 90 degrees from its original implanted position.
The lawsuit alleges that the Wright Profemur Z Hip Implant was defectively designed and manufactured and that Wright Medical Inc. failed to adequately warn consumers of potential defects and risks associated with the Wright Profemur Z Hip Implant.
The U.S. Food and Drug Administration (FDA) approved the Wright Profemur Z Hip Implant under the 510(k) protocol. The 510(k) approval protocol allows a device “substantially equivalent” to a product already approved and on the market, to bypass human trials. According to the Archives of Internal Medicine, devices approved under the 510(k) protocol tend to be recalled more often than other products. Their data shows that out of the 113 medical devices recalled between 2005 and 2009, 80 of them had been approved using the 510(k) protocol.