An Arizona woman has filed a lawsuit against Wright Medical Inc. claiming its Profemur Z hip implant is defective. According to her claim, Virginia M. Welch received a <"http://www.yourlawyer.com/topics/overview/wright-medical-profemur-hip-replacement-lawsuits">Wright Profemur Z hip replacement in 2006, only to have it removed three years later after it failed.
As we reported previously, the 2009 annual report issued by the Australian National Joint Replacement Registry, the Wright Profemur femoral stem had a cumulative revision rate of 11.2% at three years. Ideally, a hip implant should last around 15 years.
According to her lawsuit, Welch began experiencing considerable pain in her affected right hip, and medical evaluations revealed a loosened acetabular cup, which appeared in x-rays to have rotated about 90 degrees from its original position. She underwent revision surgery in November 2009.
Welch’s lawsuit alleges the Wright hip right implant was defectively designed and manufactured, and the company failed to adequately warn consumers of potential defects and risks associated with it. Welch’s lawsuit is seeking unspecified damages.
The Wright Profemur Hip Implant was approved by the U.S. Food & Drug Administration (FDA) under the agencyâ€™s 510(k) protocols. This type of approval is allowed for a device that is â€œsubstantially equivalentâ€ to a product already on the market, and does not require human trials. Unfortunately, medical devices approved via 510(k) protocols tend to be recalled more frequently than other products, according to recent research. For instance, a study published this summer in the Archives of Internal Medicine found that of 113 medical devices recalled between 2005 and 2009, 80 had undergone 510(k) approvals. In August, the Institute of Medicine recommended that the FDA do away with the 510(k) process after finding it â€œoffers patients no assurance of safety.â€