An U.K. woman has filed a product liability lawsuit against Wright Medical Technology, Inc. over problems with their Profemur hip replacement system, alleging that design defects caused the implant to suddenly break while she was walking. This is one of several Wright Profemur hip lawsuits that have been brought involving similar allegations.
The complaint was filed by Claudia Anne Hume Masters last month in the U.S. District Court for the Western District of Tennessee.
Masters, who resides in Great Britain, received the implant in 2005 and alleges that last June, problems with the Wright Profemur hip replacement resulted in catastrophic failure of the medical device.
According to the complaint, the stem of the Wright hip implant probably had an oxygen rich metallic inclusion that occurred when the titanium alloy was in the liquid metal stage. The area around such inclusions tend to be brittle and cracked. In this case the crack was found at the point of maximum stress loading for the implant.
The lawsuit charges Wright with strict liability and negligence, and Masters is seeking $2 million in compensatory damages for medical expenses, lost earning capacity, pain and suffering, lost enjoyment of living, disfigurement and permanent impairment.
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 number of other Wright hip replacement lawsuits have been filed on behalf of individuals who have experienced similar problems. Some 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.