Alabama Man Files Stryker Hip Recall Lawsuit Over Faulty Rejuvenate Implant
William Lucy filed a Stryker hip recall lawsuit on April 21, 2013 in the U.S. District Court, Northern District of Alabama (Southern), claiming the defendants manufactured and sold a defective Rejuvenate modular hip system, causing him to suffer serious complications and injuries. The device in question was approved for sale by the FDA in 2008. Made of a cobalt-chromium neck that fits into a titanium stem, the Rejuvenate featured a unique design that could purportedly help active young patients attain better stability and flexibility.
However, as plaintiff Lucy would discover, the Rejuvenate’s metal-on-metal components were prone to excessive fretting and corrosion. He was implanted with the device in 2010, and by 2013 had to undergo revision surgery due to Stryker hip complications including heavy metal poisoning, pseudotumors, inflammation and other health problems.
Stryker hip recall lawsuit alleges fraudulent concealment
According to court documents, revision surgery of the femoral stem is usually much more invasive and complex than the initial hip replacement surgery since the femoral stem has to be completely removed, rather than simply replacing the bearing surfaces. Additionally, revision surgery for the Rejuvenate implant often has a higher incidence of hip complications since metal particles from the components may have infiltrated the surrounding tissues. Lucy alleges that due to the faulty implant, which has since be pulled off the market in a Stryker Rejuvenate recall, he has incurred substantial medical expenses, physical and mental pain and suffering, permanent disability and other damages for which he seeks compensation.
Following the Rejuvenate recall of 2012, Strkyer Orthopaedics sent out an “Urgent Update Product Recall” letter to hospitals that updated corrective measures for patients with the hip replacement system. The notice suggested that surgeons perform routine examinations and tests for metal contamination even if the patient remains asymptomatic. The Class II recall affected some 53,000 ABG II and Rejuvenate units that were implanted in thousands of American patients like William Lucy.
The plaintiff charges Stryker with concealing known defects, early failure rates and known problems and risks linked to the Rejuvenate well before the product recall was issued. His lawsuit claims that had he known of the latent dangers and inherent risks posed by the hip replacement device, he would not have consented to receiving the Rejuvenate system during his total hip arthroplasty. William Lucy is requesting compensation for medical expenses related to his revision surgery, past and future lost wages, mental anguish, physical pain and suffering, legal costs and attorney fees, exemplary damages, plus further losses that the court deem just and proper.
Lawsuits claim Stryker hip complications not rare
Since first launched via the FDA’s “fast-track” 510k admission process, the Rejuvenate total hip replacement system has been linked to unreasonably high failure rates and problems such as pain in the implant area, popping noises, swelling, reduced mobility, metallosis (metal ions in the bloodstream), bone fractures, and the need for revision surgery. The FDA has since questioned the value and safety of any type of hip replacement system that uses metal-on-metal components, amid growing evidence that the risks of metal poisoning and total hip failure far outweigh any benefits.