Judging by the fact that approximately 7,700 patients were impacted by Smith & Nephew’s June 2012 decision to recall the metal liner component of its R3 Acetabular System, the number of Smith and Nephew hip lawsuits may rise in the coming months. If you experienced a side effect stemming from this device, you too may be eligible to file a Smith & Nephew hip lawsuit against the British manufacturer of all-metal artificial hip systems.
The following side effects are associated with the Smith & Nephew hip recall:
Smith and Nephew Hip Lawsuits Already Filed
Smith & Nephew hip lawsuits have already begun to be filed in the U.S. On Nov. 27, 2012 for example, one case was brought to California state court by a man who says he suffered complications stemming from metallosis (metal ion poisoning) after being implanted with the R3 hip implant. Filed in Sacramento County Superior Court, the Smith & Nephew hip lawsuit was moved to the U.S. District Court, the Eastern District of California exactly a month to the day later, on Dec. 27 as per an action for removal by Smith & Nephew.
In his lawsuit, the plaintiff says he received the R3 implant in his left hip during September 2010, and only had it for two months before undergoing revision surgery to remove it. This was prompted by his “hearing a grinding noise” at the joint location.
The plaintiff’s surgeon diagnosed his issue as “prosthetic failure, acetabular metal liner, with displacement and rotation of the liner,” and “diffuse synovial metallosis [sic] debris which was excised and debrided,” according to court documents.
The plaintiff also pointed out that the R3 system’s metal liner did not explicitly receive approval by the U.S. Food and Drug Administration (FDA) before it was globally launched in 2009. It was instead granted approval by way of the FDA’s 510(k) process, which permits a manufacturer to market a product as long as it can prove it to be largely equivalent to one that has already received approval.
FDA Proposes New Guidelines for Metal-on-Metal Hip Replacements
In light of the early failure rates, metallosis and high rates of revision surgeries stemming from metal-on-metal hip implants, the U.S. regulatory agency is taking action. This January, the FDA announced its proposal that would require all metal-on-metal hip implant manufacturers to receive premarket approval on their designs before they can be sold to the public. This will make these devices ineligible for the 510(k) process, which may allow a product to bypass extensive clinical testing.