Feds Investigating Wright Medical' Profemur Hip Replacement SystemAug 8, 2012 | Parker Waichman LLP
Wright Medical Inc. disclosed yesterday that it has received a federal subpoena from the U.S. Attorney's office in the Western District of Tennessee seeking information about its Profemur hip replacement line, which includes metal hip stems and total hip replacement systems. In its latest earning statement, Wright said it was cooperating with the probe, and working to comply with a subpoena to provide “records and documentation" on Profemur hip replacement products from a period between January 1, 2000, and August 2, 2012.
A report from Mass Device speculated that the Wright Profemur might be at risk following last month's recall of Stryker's Rejuvenate Modular and ABG II modular-neck hip stems. Stryker recalled and terminated global distribution of the Rejuvenate and ABG II products on July 6, after continued post-market surveillance indicated the devices may be prone to “fretting and/or corrosion at or about the modular-neck junction,” which may lead to pain, swelling and adverse reactions in surrounding tissue. Both of the Stryker hip implant components are two-part modular-neck systems that consist of a metal neck inside a metal stem.
"Although Stryker's recalled modular hip stems differ in design and material from our Profemur modular neck hip stems, there is a risk that Stryker's recall and the resultant publicity could negatively impact sales of modular neck systems of other manufacturers, including our Profemur system, even if the issues cited by Stryker are unique to Stryker products," Wright said in its earning statement.
The company also maintained that the subpoena was "not an allegation of wrongdoing or product safety issues" and doesn't impact its ability to sell the devices.
As we reported previously, the 2009 annual report issued by the Australian National Joint Replacement Registry, the Wright Profemur femoral stems had a cumulative revision rate of 11.2% at three years. Ideally, a hip implant should last around 15 years.
The Wright Profemur Hip Implant System was approved by the U.S. Food & Drug Administration (FDA) under the agency's controversial 510(k) protocols. This type of approval is allowed for a device that is "substantially equivalent" to a product already on the market, and does not require human trials. A study published last summer in the Archives of Internal Medicine found that of 113 medical devices recalled between 2005 and 2009, 80 had undergone 510(k) approvals. Last August, the Institute of Medicine recommended that the FDA do away with the 510(k) process after finding it "offers patients no assurance of safety."