FDA to Launch Metal Hip Study Amidst Mounting Stryker Recall Claims, DePuy Pinnacle Lawsuits
The U.S. Food and Drug Administration (FDA) is reportedly launching a study to look at how metal-on-metal hip replacements, like those affected by the Stryker hip recall, DePuy ASR recall, and those named in DePuy Pinnacle lawsuits are worn down, according to a recent update from the agency.
A solicitation notice posted July 23rd on the Federal Business Opportunities (FBO) website indicates that the project will analyze 250 explanted metal-on-metal hips of various genders and sizes, and use the American Society for Testing and Materials (ASTM) protocol for corrosion testing to analyze the devices.
The purpose of the study, according to the FDA, is to “investigate the potential link between volumetric wear and corrosion of conical head/stem taper junctions in explanted total hip replacements and clinical outcomes.”
“There is renewed concern of wear and corrosion of conical head/stem taper junctions in modern modular total hip replacements,” the agency said.
The project should take about two years to conduct, according to the Federal Business Opportunities (FBO), and will ideally result in a peer-reviewed journal article explaining the connections between corrosion and wear and factors including implantation time, head size, materials, modularity and lateral offset.
Thousands of Metal-on-Metal Hip Claims Filed in Wake of DePuy ASR Recall, Stryker Hip Recall
Early metal-on-metal hip failure complications alleged in a continually rising number of claims over the Stryker Rejuvenate/ABG II devices, the now-recalled DePuy ASR device and Wright Conserve hip have also furthered the agency’s need to investigate this class of devices.
In Stryker’s case, the Rejuvenate and ABG II hip implants were recalled in July 2012 after company data showed the potential for the implants’ metal components to fret and corrode at the modular-neck junction. As a result, metal hip recipients have allegedly suffered injuries associated with metallosis, necrosis, osteolysis, and complications necessitating the need for revision surgery.
As of August 9th, at least 273 Stryker lawsuit claims had been filed in a consolidated proceeding established in New Jersey’s Bergen County Superior Court, while more than 159 cases were pending in a federal proceeding established in the District of Minnesota.
Hundreds of lawsuits have also been filed over a version of the DePuy Pinnacle Hip Replacement System that includes a metal Ultamet liner. In the federal litigation currently underway in the Northern District of Texas, more than 4,600 cases involving the DePuy Orthopaedics-manufactured device had been filed as of August 2nd, according to a Master Case List update.
Injured by an Implant Affected By the Stryker Hip Recall or DePuy ASR Recall? Contact a Lawyer Today.
Contact an attorney at Bernstein Liebhard LLP to learn more about your legal rights, and if you are eligible to file a claim at (877) 779-1414.