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Stryker Rejuvenate Hip Recall Update
The Stryker Rejuvenate hip replacement device has been linked with an increased risk of metallosis and other adverse effects. While the product is not a metal-on-metal hip implant, it does possess some types of metal components that can lead to metallosis. Many victims have had to also undergo revision surgery due to the adverse effects of the device. This process is costly and has led many victims to file lawsuits for medical compensation and emotional distress. The Stryker Rejuvenate hip implant recall is a result of thousands of lawsuits after problems associated with the medical product came to light. About 20,000 hip stems were recalled by the company, and the litigation battle is expected to be massive. If you have been affected by this product recall and need to find out how to file a lawsuit, please contact our experienced law firm and get the legal counsel necessary that you deserve.
The Stryker Rejuvenate hip implant was marketed as different than other hip replacement devices because it was not considered a metal-on-metal product. It’s important to note that the device does use a ceramic component. Originally, the product was marketed to younger patients as a modular hip replacement meant to be custom fit to patients. This would allow them to move around more easily and be more active. The product was also meant to last longer than other hip replacement devices available on the market.
Recent research has found a connection between corrosion and the Stryker device and that the hip replacement appeared to cause soft tissue destruction. In May 2013, a report was published in The Journal of Bone and Joint Surgery that had studied 12 hip replacements in patients who used a modular femoral stem designed by Stryker Rejuvenate. The product does have several metal components including a modular cobat-chromium alloy neck. All of the patients involved in the study needed revision surgery. During revision surgery, doctors reported that they found visible soft tissue destruction and corrosion at the femoral neck-body junction in all of the patients. These patients also were found to have a high level of metals in their bloodstream including chromium, cobalt and titanium and were diagnosed with metallosis. These findings concluded that individuals who have received the Stryker Rejuvenate hip implant should have their local tissue examined and their blood tested for metallosis to avoid further complications.
Since the report was published, many patients have been diagnosed with metallosis after receiving the Stryker Rejuvenate hip implant. A number of these patients reported their results to Stryker. The corporation responded to concerns about their product by alleging that patients receiving their products were not undergoing proper rehabilitation following surgery. The company also claimed that many problems were the result of doctors making mistakes during implantation. Initially, it was considered impossible that the patients’ metallosis was a result from the product because the Rejuvenate device doesn’t use a metal-on-metal ball and socket design. It was later discovered that the metal neck piece of the product can rub against its metal stem causing metallic debris to loosen and affect the body. In April 2012, Stryker ceded that certain factors such as diabetes and infections could lead to corrosion due to a variation in the pH level of tissue surrounding the implant.
Metallosis is a serious tissue reaction in the body against heavy metals. It can cause pain, lower mobility, failure in joints, pseudo-tumors, bone dissolution, DNA changes and chromosomal aberrations. Additionally, the Rejuvenate device was meant to last from 15 to 20 years. In many cases, the product has failed in under five years requiring patients to undergo revision surgery. The problems associated with this product can cause a lifetime of medical issues and significant costs. It’s important that people who believe to be suffering from adverse effects associated with the Stryker Rejuvenate hip replacement contact an expert attorney as soon as possible.
In July 2012, Stryker announced a recall on its Rejuvenate hip device and its ABG II modular-neck stems. The company claimed the recall was a result from various reports of fretting and corrosion and that the Federal Drug Administration had found two cases where adverse effects had been reported in patients. In one of the patients, Stryker reported, the device had been removed. A few months after announcing the recall, the corporation advised patients who had received the Rejuvenate or ABG II stems to undergo blood testing for metal ions. The most common adverse effects associated with these products are listed below:
Since Striker first announced the recall, a large number of lawsuits have been filed against the company on behalf of victims. Many patients claim they have suffered from metallosis, bone dissolution and tissue death around the implant. As of May 2013, over 160 lawsuits surrounding the recall have been filed. Lawsuits are being filed to give victims compensation for their pain, lost wages, medical costs and suffering.