August 9, 2012 — In a regulatory earnings report filing, Wright Medical Group (Arlington, Tennessee) disclosed that that they received a subpoena from the U.S. Attorney’s Office for the Western District of Tennessee. The subpoena seeks documents related to the company’s Profemur line of hip replacement devices. The U.S. Attorney’s office has requested “records and documentation” from January 1, 2000 until August 2, 2012.
The Wright Profemur is a modular-neck hip implant, which is similar to two hip implants made by Stryker Corp. that were recalled in July. The Profemur was not recalled.
In a statement from the company, they said the subpoena “is not an allegation of wrongdoing or product safety issues” and “we are cooperating with the U.S. Attorney to provide the requested information.”
Wright Medical’s Profemur hip implants include metal hip stems and total hip replacements.
The Wright Profemur hip implant is designed with a modular neck. The adjustable femoral neck is intended to bend, so a surgeon implanting the device can fit it to match a patient’s unique anatomy.
Another modular-neck hip implant, the Stryker ABG II and Rejuvenate hip implants, were recalled in July 2012 after the company found an unacceptably high rate of failure, corrosion, and metal debris.
In a filing with the Securities and Exchange Commission (SEC), Wright said that “although Stryker’s recalled modular hip stems differ in design and material from our Profemur modular neck stems, there is a risk that Stryker’s recall and the resultant publicity could negatively impact sales of modular neck systems of other manufacturers.”
After the U.S. Attorney’s office reviews the documents, it is possible that attorneys will have a better idea of how many hip implants have been sold, how many have been implanted, how many have failed — and they may be able to determine the rate of failure. Hip implants are supposed to last 15 years, but in recent years, there have been several high-profile recalls when companies found that the implants failed prematurely at a high rate.
Although the FDA has received thousands of reports of hip implant failures, it is difficult for the government to evaluate the rate of failure. This is because the U.S. does not have a system for tracking the performance of medical devices.
Modular-neck hip implants have a metal-on-metal component in the neck of the device — unlike other hip implants, which have a solid neck. In some cases, the metal-on-metal parts can grind together and shed particles of chromium and cobalt into the patient’s body. These metal nano-particles can cause many serious side effects — including pain, inflammation, dislocation of the hip joint, growth of non-cancerous pseudotumors, and more. In some cases, the metal particles can leach into the bloodstream and cause metal poisoning.
Do I have a Wright Profemur Lawsuit
The Schmidt Firm, PLLC is currently accepting Stryker Rejuvenate, Wright Profemur, and other defective hip implant induced injury cases in all 50 states. If you or somebody you know has been injured by a defective hip implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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