August 9, 2012 — Tennesee-based medical device company Wright Medical Technology has been subpoenaed by the U.S. Attorneys Office for the Western District of Tennessee.
Government officials are requesting “records and documentation” regarding the Wright Profemur hip implant from January 1, 2000 until August 2, 2012. The Wright Profemur is a modular-neck hip implant that is similar to two hip implants made by Stryker that were recalled earlier this year. Wright maintains that the Profemur does not have the same defects as the Stryker hip implant.
The company released a statement, saying the subpoena “is not an allegation of wrongdoing or product safety issues.” The company also stated that they are cooperating with the U.S. Attorney to produce the requested documentation.
In a regulatory filing with the Securities and Exchange Commission (SEC), Wright noted that the Stryker modular-hip implant recalls could affect the Profemur hip implant. They said, “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.”
In July 2012, Stryker Corp. recalled the ABG II and Rejuvenate modular-neck hip implants after linking the devices to a high rate of corrosion and fretting. The metal-on-metal parts of the modular neck can grind together and shed toxic metal nano-particles of chromium or cobalt into the body.
The Wright Profemur is also designed with a modular neck. The femoral stem can bend and adjust, which was intended to help a surgeon fit the device to match each patient’s unique biomechanics.
The Stryker recall was initiated because the company was concerned about a high rate of failure. The Wright Profemur failure rate is unknown. Although medical device companies are required to notify the FDA when they receive injury reports, the do not need to disclose how many devices have been sold or implanted in patients. It is difficult for outside agencies to determine the failure rate of many devices. The U.S. also lacks a surveillance system to track the performance of medical devices, which can delay identification of safety issues and subsequent recalls.
It is possible that the documents will help the U.S. Attorneys get a better idea of how often the Profemur has failed. Hip implants are supposed to last about 15 years. Unfortunately, in recent years, several hip implants have been recalled (most notably the DePuy ASR hip implant recall in 2010) after companies linked the devices to high premature failure rates.
The problem with metal-on-metal hip implants and modular-neck hip implants is that the metal parts can grind together and release small particles of chromium into the body. This metal debris can corrode, release charged cobalt ions, and cause severe tissue damage, bone loss, inflammation, pain in the hip, and other serious complications that require corrective surgery.
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