A Colorado man has filed a hip replacement lawsuit against Wright Medical Group, claiming that a Wright Profemur hip system catastrophically failed due to defective and negligent design.
The Wright Profemur hip lawsuit was filed last month in Colorado state court by Glenn A. Wollam and his wife,
Bonnie J. Shoenstein. Wollam alleges that he received a Wright Profemur hip replacement in April 2005, which failed in October 2008.
The femoral neck of the Wright Profemur hip system implanted on Wollam’s right side broke, requiring additional surgery to remove the failed artificial hip. According to the complaint, the Wright Profemur hip implant broke during normal use, causing Wollam to suffer severe pain and resulting in permanent physical impairment and disfigurement.
Wollam also has a Wright Profemur hip replacement on the left side, which has not failed. However, the complaint alleges that the hip implant is subject to the same defects as the failed right side device, including a risk of “degradation, fretting, corrosion, wear, fatigue and loading”.
The Wright Profemur Total Hip System used during Wollam’s original hip replacement included the Conserve Plus Cup, Conserve Total Femoral Head, Wright Modular Femoral Neck and Profemur E Cementless Stem.
According to allegations raised in the lawsuit, the Wright Profemur hip system is unreasonably dangerous in that the neck was manufactured in a manner as to be subject to bend, leading to rapid deterioration and an increased risk of failure. The hip implant neck is designed to be modular, so that it can be adjusted for leg length, but the lawsuit alleges that the design increases the potential for fretting, corrosion and failure.
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 just had to show that it was substantially equivalent to an existing medical device to get it on the market.
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 was identified as having a higher than anticipated revision rate, with a cumulative percent revision of 11.2% at three years.
Earlier this year, a DePuy ASR hip replacement recall was issued by Johnson & Johnson and DePuy Orthopaedics after data confirmed that the metal-on-metal hip replacement had a failure rate of 12%. However, that recall was not issued until several months after the first DePuy ASR hip lawsuits were filed.