A Michigan man has filed a product liability lawsuit that indicates his Wright Profemur hip replacement failed less than three years after being implanted, when the femoral neck of the hip implant broke.
The Wright Profemur hip replacement lawsuit was filed by Terrance Allore and his wife, Rebecca, on August 17 in the U.S. District Court for the Eastern District of Michigan. It names Wright Medical Group, Wright Medical Technology and Wright Medical Europe as defendants.
According to the complaint, Allore received the Wright Profemur Total Hip System in January 2008, but in November 2010 he experienced severe problems with the hip replacement when the femoral neck of the implant broke, causing a catastrophic failure that required Allore to undergo additional surgery to replace the broken hip implant.
The lawsuit calls the Wright Profemur hip problems a sign that the implants are defective, dangerous to the health of recipients and fail to meet established performance standards. The complaint accuses the manufacturers of defective manufacturing, defective design, failure to warn, misrepresentation, negligence, breach of warranty, and fraud. Allore’s wife is also suing for loss of consortium.
The Wright Profemur Total Hip System was approved in the United States by the FDA through the controversial 510(K) premarket approval process, which means that the company was able to begin marketing the device without rigorous testing, as it was deemed to be substantially equivalent to an existing medical device.
Although a registry for knee and hip replacements has not existed in the United States until recently, data on knee and hip implants are tracked in some other countries. According to data in the 2009 annual report of the Australian registry (PDF), the Wright Profemur Z hip implant was identified as having a higher than anticipated revision rate, with a cumulative percent revision of 11.2% at three years.
A growing number of individuals throughout the United States have also filed a Wright hip replacement lawsuit after experiencing similar problems. Many of the complaints involve situations where the femoral neck of the Wright Profemur implant broke or fractured during normal use, resulting in severe pain and the need for revision surgery to replace the Wright Profemur hip system.