What Is Wright Medical’s Profemur Z Hip Replacement?
The Wright Profemur Z Hip Stem was designed to be a minimally invasive hip replacement better than all previous types of implants. Instead of creating hip implants with fixed neck (“stem”) lengths, Wright Medical’s Profemur Z hip replacements use interchangeable titanium necks to equalize leg length and otherwise conserve bone mass and hasten recovery. Using multiple parts was supposed to be a leap forward in artificial joint technology.
Like many other hip replacement system manufacturers, Wright Medical Technologies used the 510(k) premarket approval process to get its product to market as quickly as possible without mandatory clinical trials. The 510(k) process, considered by some to be a regulatory “loophole,” requires manufacturers to demonstrate that their products are “substantially equivalent” to those already on the market. Despite patenting the modular neck portions of the hip replacements that are supposed to be an advancement over the fixed necks of previous implants (which requires a showing that the concept is “novel”), Wright Medical Technologies somehow convinced the U.S. Food and Drug Administration (FDA) that the Profemur Z hip replacement was substantially equivalent to similar products already on the market. The results have not been good.
Wright Profemur Z Hip Replacements Fail at High Rates
Much like with other artificial joints with unusually high failure rates, and due to the lack of an artificial joint registry in the United States, it was the Australian National Joint Registry that discovered that Wright Medical’s Profemur hip replacement failed at a rate of 11.2 percent after three years, necessitating painful revision procedures in recipients. The FDA has received only a handful of negative reports, so it has neither issued a Wright Profemur Z hip replacement warning nor required a Wright Profemur Z hip replacement recall.
Nonetheless, Wright Profemur Z hip replacement lawsuits are growing in number, though it is unknown how many are Wright Profemur Z hip replacement class action lawsuits. The plaintiffs involved claim that the hip implant was badly designed and that the innovative new design was also the product’s weakness: The flexible hip stem is too weak, so it frets, degrades, fractures, or breaks entirely. One Colorado plaintiff, who filed her Wright Profemur Z hip replacement lawsuit in late January 2011, claims that the hip replacement’s acetabular cup was supposed to fuse to her pelvis but did not. During her revision procedure, her orthopedist found that the cup was barely attached to her pelvis. More lawsuits are expected to follow.
In 2012, Wright Medical admitted in a Securities and Exchange Commission (SEC) filing that on August 3, 2012, the U.S. Attorney’s Office for the Western District of Tennessee subpoenaed Wright Medical for all documents related to the Profemur since January 1, 2000. Wright Medical did not disclose why the U.S. Attorney’s Office was interested in the Profemur, just that Wright Medical was complying with the subpoena.
The SEC filing contained other statements about the Profemur hip replacement series as well. For instance, Wright Medical’s executives were concerned that a recall of modular stemmed hip replacements by one of the company’s competitors, Stryker, would negatively impact sales. Also, the company calculated that its losses due to Profemur hip replacement lawsuits would fall between $24 million and $39 million.
Let RLG Make a Wright Profemur Z Lawsuit Less Painful
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Wright Profemur Z Hip Replacement lawyers at the Rottenstein Law Group believe that getting satisfaction from the company that harmed you shouldn’t be just more hardship. That’s why we do everything we can to streamline the process. If you have received one of these devices and are concerned that it has or will fail, contact RLG today.