In 2007 and 2012, Stryker recalled three of its metal-on-metal hip replacement devices. In 2007, the company recalled the Trident hip, and in 2012, it recalled the Rejuvenate and ABG II models. Receipients of these devices experienced difficulties shortly after they were implanted with the devices. Those difficulties included pain, swelling, limited mobility, and metal poisoning from the components.
A great many of the recipients have had to undergo revision surgeries to remove and replace the Stryker implants within 2-to-5 years of the original procedure.
Lack of Testing and Greater Number of Moving Parts Thought to Be the Main Causes of Recalls
According to reports, the Stryker hips were only laboratory-tested before being made available to the public. The U.S. Food and Drug Administration (FDA) granted approval for the devices based on Stryker’s representation that the design was substantially similar to a product that had already been approved: Wright Medical Techology’s Profemur Total Hip Modular Neck System.
Subsequently, under the FDA’s 510(k) approval process, the Stryker implants were essentially “grandfathered” in with very littlle pre-market scrutiny. Moreover, Wright Medical’s Profemur system was subsequently linked to high failure rates, resulting in many patients having to receive revision surgeries to remove the Profemur.
Additionally, the numerous moving parts that comprised the Rejuvenate and ABG II models were thought to be responsible for a higher instance of failure. The additional parts carry the risk of fretting from too much movement, and given that they are made entirely from metal, they are more likely to shed microscopic particles, which can cause pain, swelling, inflammation and metal poisoning.
Orthopedic surgeons and representatives from the FDA are in agreement that all-metal hip replacements, like those recalled by Stryker and other manufacturers, provided no additional benefit to patients. Many who have had to undergo revision surgeries were subsequently implanted with ceramic and/or plastic hip implants, the very devices the recalled Stryker models were meant to replace.
Stryker Hip Recipients Should be Mindful of Failure Symptoms
It is important to consult your orthopedic surgeon to determine whether or not the symptoms you might be experiencing are consistent with a failed hip replacement implant, and if that implant was manufactured and sold by Stryker.
Additionally, many recipients are filing lawsuits against Stryker alleging injuries stemming from implantation of the recalled implants. Plaintiffs are seeking compensation for pain, suffering, unforeseen medical expenses, lost wages and other damages.