The Wright Profemur hip implant system has been named in another lawsuit after an Arizona woman had to undergo revision surgery just three years after being implanted with the defective medical device.
The lawsuit, filed on behalf of Virginia M. Welch of Mesa, Arizona, is pending in the United States District Court for the District of Arizona, said Digital Journal. The complaint alleges that Welch received her Wright Profemur Z implant in February 2006. Intense pain led to medical evaluations that confirmed the device’s acetabular cup loosed and rotated about 90 degrees from its original implant position, explained Digital Journal. The complaint alleges defective design and manufacture and that the device maker never warned of the device’s potential defects and risks, said Digital Journal.
Last month, NewsInferno wrote about two other lawsuits that alleged that Wright Profemur Hip Implants fail with a few years of implantation, much sooner than these devices tout. In one lawsuit, filed this August, the plaintiff alleged that a Wright Profemur Hip Implant failed after the device’s femoral neck broke, said NewsInferno. The other case is a Canadian Class Action lawsuit filed in September that alleges that Wright Medical and other defendants knew a high number of their Profemur Z Stems were failing and injuring patients, but neglected to disclose or warn patients about the significant risks.
The Wright Profemur Hip Implant was approved by the U.S. Food & Drug Administration (FDA) under the agency’s 510(k) protocols. This approval enables devices “substantially equivalent” to already approved devices, to receive approval without human trials. Sadly, notes NewsInferno, medical devices approved via 510(k) protocols tend to experience more frequent recalls versus other products, citing recent research.
NewsInferno pointed out that recent data suggests that the Wright Profemur Hip Implant tends to fail sooner than expected and that the 2009 annual Australian National Joint Replacement Registry report revealed that the Wright Profemur Hip Implant experienced a cumulative revision rate of 11.2% at three years. Hip implants are typically designed to last 15 years, NewsInferno noted.
In other words, about one of every 9 people who have been implanted with the Wright Profemur hip implant experienced very significant problems within only a few years of receiving their hip replacements. Problems include complaints of hip pain, problems standing or walking, and implant loosening that can call for more complex and painful revision surgery in which the Wright device is removed and a different device is implanted.
Issues with Wright Devices involve problems with the Wright Profemur Z Femoral Stem, designed to be modular and enable for leg length adjustment. This feature can also enable the stem to bend easily, which can lead to device fracture, breakage, degradation, and fretting, which refers to wear and breakdown of the device’s contact surfaces.