Stryker Rejuvenate Recall – Metal-on-Metal Style Hip Replacement Recall
Patients who have undergone total hip replacement surgery and were implanted with the Stryker Rejuvenate or the Stryker ABG II modular-neck hip systems may be eligible for a Stryker Rejuvenate lawsuit. Though the Rejuvenate was launched only three years ago in 2009, the manufacturer has already implemented a voluntary Stryker Rejuvenate recall involving both the Rejuvenate and the ABG II systems.
According to the Stryker Orthopedics website, the voluntary recall was initiated due to the "potential risks associated with modular-neck stems" which can lead to pain, swelling, tissue reactions, and premature hip implant failure. A Stryker Rejuvenate lawyer is familiar with the the risks associated with these devices, and is likely to receive more calls about injuries now that the recall has been announced.
Stryker Rejuvenate Recall a Result of Reports of Metal Poisoning
An FDA advisory panel convened a two-day meeting on June 27–28, 2012, to discuss safety issues surrounding metal-on-metal implants. These implants, instead of matching a metal ball with a ceramic or plastic socket, use all metal components. They were originally designed to be more long lasting and flexible than older implants, but post-marketing reports indicated they were subject to frequent complications, including metal poisoning resulting from the metal components rubbing against one another and shedding shards of cobalt and chromium into the surrounding tissues and bloodstream.
The Stryker Rejuvenate and ABG II systems were not originally labeled as metal-on-metal systems, because they contain a ceramic component and do not pair a metal ball with a metal socket. They do, however, offer a so-called "update" in the femoral stem. Instead of a one-piece, fixed stem and neck, such as that used by other implants, the neck and stem are two different components. This was intended to provide surgeons with more options in fitting patients, with mix-and-match necks and stems, but again, post-marketing reports show that in some cases, the neck and stem wear against one another, releasing metallic debris into the body.
Stryker Rejuvenate Lawsuits
Metal debris can cause numerous problems that can shorten the life of the implant. These include significant pain, tissue damage and death, bone damage and bone loss, and pockets of swelling called "pseudotumors." All of these can affect the fit of the implant, and lead to premature loosening, shifting, and eventual implant failure. Patients suffering these complications often have to go through revision surgery to have the implant replaced.
The FDA has reportedly received more than 60 adverse event reports concerning problems with the Stryker modular-neck systems, and that number is going up. As these devices have been on the market only a short time, it is expected that more patients will be coming forward with problems in the coming months, which may also increase the number of plaintiffs filing a Stryker Rejuvenate lawsuit.
A Stryker Rejuvenate Lawyer Can Help
If you or a loved one were implanted with one of these devices, and you have experienced complications like those named here, you may benefit from a consultation with a Stryker Rejuvenate lawyer. Companies that release devices onto the market without thorough safety testing should be held responsible for resulting injuries suffered by patients. Chaffin Luhana LLP has years of experience in representing patients injured by medical devices, and will not charge you unless your Stryker Rejuvenate lawsuit is successful. Call today for a free and confidential case evaluation at 1-888-480-1123.