The Stryker Rejuvenate modular neck implant system was manufactured by Stryker Orthopaedics. It used metal components that can lead to health problems when the metal begins to fret or corrode with use. Problems with the Stryker Rejuvenate implants led the company to issue a voluntary recall in July 2012.
The recall came after thousands of patients had already received implants using the Stryker Rejuvenate system. Many of the implant recipients were younger, more active people who wanted more mobility and greater longevity than offered by traditional hip implants. However, the Stryker Rejuvenate hips quickly began causing significant health problems for many patients soon after they were implanted. The problems that prompted the July 2012 recall have also led many patients to file lawsuits against Stryker to recover compensation for the harm they suffered.
If you or a loved one experienced complications as a result of a Stryker Rejuvenate hip implant or other Stryker products, you should consult with an experienced defective medical device attorney at Roberts & Roberts to learn about your legal options.
About the Stryker Rejuvenate Hip Implant
Hip implant procedures generally involve attaching a replacement joint to the femur by hollowing out the femur and inserting a stem. The stem fits into a cup that is inserted into the acetabulum, which is a concave area in the pelvis.
The cup and replacement joint can be made from several different materials, including ceramic and other synthetic materials. Metal-on-metal hip replacement products – including the Stryker Rejuvenate hip implant – use a metal acetabular cup (the cup inside the acetabulum) and a metal replacement joint
These products came to the market under 510(k) rules, a provision in the U.S. Food and Drug Administration (FDA) regulations that allows a medical device manufacturer to sell a product that is substantially similar to devices already approved without conducting the testing that would otherwise be necessary. Stryker’s Rejuvenate system was approved under the 510(k) process in June 2008.
It soon became clear that the Stryker Rejuvenate implant had problems that were unique to its design. Unlike other hip implants, the Rejuvenate system had several parts that fit inside the femur to secure the implant. Many other hip products had just one type of stem that was inserted into the femur, along with one type of neck that attached to the top of the bone. The Rejuvenate system had six stems and a total of 16 necks.
The Rejuvenate stems were made of metals such as titanium, molybdenum and iron. They were supposed to be more flexible because surgeons could custom fit the stem and neck to each individual patient. Despite the supposedly tailored fit, the Rejuvenate still allowed metal components to rub against each other, similar to metal-on-metal hip implants. As a result, Stryker Rejuvenate hip implants can result in metal debris flaking off and entering the body, causing health problems.
Some of the medical issues that may be caused by Stryker Rejuvenate hips include:
- Metallosis– A toxic buildup of metal ions. The FDA warns that metallosis can affect the nervous system, thyroid gland and heart, while the British Medical Journal warns of damage to the kidneys, muscles, liver and lymph nodes.
- Necrosis– The death of tissue in the body.
- Osteolysis– A breakdown of the bone. The American Academy of Orthopedic Surgeons has cautioned that the number of patients needing surgery to correct this problem may double over the next decade due to the problems with hip implant and replacement products.
- Pseudo-tumors– A tumor-like collection of metal flakes and fluid.
- Bone fractures – Broken bones may be caused by loose fittings that secure the implants.
Addressing the problems caused by defective hip implants almost always involves a revisionary surgery that may include removing the implant and rebuilding the hip. Some of the problems caused by the metal debris released by the Stryker Rejuvenate hip implant may be irreversible, leaving victims with a lifetime of health impairments.
Medical Problems Caused by Stryker Rejuvenate? Our Hip Implant Lawyers Can Help
Studies and adverse reaction reports have shown that Stryker Rejuvenate hip implants can cause serious health problems. Due to the mounting concerns and the growing number of adverse claims, Stryker recalled the Rejuvenate implant system on July 6, 2012. This recall came too late for many of the patients who had already developed complications and who have undergone painful corrective surgeries.
If you or a loved one has been injured by a Stryker Rejuvenate hip implant, you could be entitled to compensation.
At Roberts & Roberts, our experienced defective hip implant attorneys help patients get the money they deserve to compensate them for their losses. For a free, confidential review of your claim, call us today at 903-597-6000 or contact us online. The call costs you nothing… It could mean everything.