Stryker Rejuvenate Recall Femoral Heads
Patients across the United States are receiving letters from their Orthopedic Surgeons alerting them to recall concerning a certain LFIT ANATOMIC COCR V40 FEMORAL HEADS due to serious safety risks. Other patients have received letters from the device manufacturer, Stryker, or a company hired by Stryker. It is important that you know Stryker is facing serious consequences due to device failure, therefore, they are not on your side. You will need an attorney experienced in complex medical defective device litigation to protect your rights to compensation for your injuries. Compensation could include medical expenses, pain and suffering, loss of enjoyment of life, loss of consortium, wage loss, and more.
Many patients have been forced to have emergency revision surgeries and others are experiencing debilitating pain. Other devastating side effects that have been reported are device corrosion, device heads breaking free from the hip system, metal poisoning, and more.
If you or a loved one have received a letter from your Surgeon, Stryker, or a company representing Stryker, you may be eligible for compensation. Call today for a free consultation, 24/7.
STRYKER’S LATEST RECALL
STRYKER REJUVENATE LATEST RECALL – LFIT ANATOMIC COCR V40 FEMORAL HEADS
Just as Stryker Rejuvenate and ABG II hip system lawsuits wind down with a settlement of $1.4 billion, the medical device manufacturing giant issued a recall of certain LFIT V40 cobalt-chromium femoral heads used in a wide range of hip implant systems, including Rejuvenate and ABG II, exposing them to further claims of negligence (see a complete list of hip implant systems below). The recalled femoral heads were manufactured prior to 2011.
There have been devastating side effects for some patients, including “spontaneous dissociation” which requires painful, invasive revision surgery to correct. Spontaneous dissociation is the terminology used by surgeons when they find such significant corrosion that the LFIT head has actually broken free from the femoral stem. With or without spontaneous dissociation, many patients have experienced metal poisoning when metal ions release into the body as the device corrodes. When this happens, serious systemic damage can occur.
If you or someone you love have received one of the hip implant systems below, please contact our office immediately as it may include one of the LFIT V40 femoral heads in question.
If you or someone you love have received one of the hip implant systems below, please contact our office immediately.
Harm to a patient who has received one of these implant systems may include:
- joint instability
- loss of mobility
- loosening implant
- revision surgery
- metal poisoning
- and more
STRYKER’S HISTORY – OVER ONE BILLION DOLLARS PAID IN PAST LAWSUIT SETTLEMENTS
Two hip implants manufactured by Stryker Corp., Rejuvenate and ABG II Modular-Neck Hip Stems, were recalled in 2012 for serious complications. The corporation, well known for its hip and knee implants, also manufactures thousands of other medical devices worldwide.
The company began in the 1940’s as Orthopedic Frame Company, based in Michigan. It has since expanded to marketing 57,000 products, reaching $8 billion in annual sales at the time of recall.
But the Rejuvenate and ABG II aren’t the only product recalls the company has faced. Stryker’s Accolade TMZF Plus Hip Stem was recalled in 2009, 2011, and 2013 for manufacturing and packaging errors. Accolade, like Rejuvenate and ABG II, is made of a proprietary titanium alloy called TMZF and the product stem was designed with a PureFix HA coating around the stem to promote bone marrow growth.
Implant systems typically include a one-piece neck, referred to as a monoblock design. These three Stryker products, however, include several neck and stem components, intending to be more anatomically correct, giving surgeons more flexibility and ability to provide a custom fit.
The ABG II system was to offer less bone stress and greater stability than other products, while Rejuvenate was marketed to younger patients, offering better range of motion in a longer-lasting device. According to Stryker, the proprietary TMZF product that mixed titanium, molybdenum, zirconium and iron would resist corrosion and fretting, meaning small metal particles would not flake off and implant themselves into a patient’s body. Further, they said their product “more closely resembles that of bone” and was stronger than others.
When evidence of corrosion and fretting were later revealed in post-market data, Stryker issued a recall of the Rejuvenate and ABG II systems. Unfortunately, for some who had already received the device, it was too late. Some of the serious side effects were indeed a release of metal debris into patients with normal use as well as loosening of the implant.
An “Urgent Safety Alert” was issued in April 2012 by Stryker to hospitals and surgeons for Rejuvenate and ABG II listing “excessive metal debris and/or ion generation,” caused by “fretting and/or corrosion at or about the modular neck junction,” which “may lead to increased metal ion generation in the surrounding joint space.”
The FDA had received more than 60 adverse event reports by July 6, 2012 stating that the metal toxicity was requiring revision surgeries. At that point, Stryker issued a recall and stopped production and sales.
Lawsuits were filed against Stryker alleging negligence for not testing the two products adequately before release. They were also accused of failure to warn both patients and the medical community of the potential side effects.
The first four lawsuits were settled in December 2013. At that time, the company had anticipated the recall and resulting lawsuits could cost them upwards of $1.3 billion. It turns out they were correct.
About Sanders Phillips Grossman
Sanders Phillips Grossman has been holding pharmaceutical companies responsible for injuring individuals by their defective drugs and devices for over 30 years. Defective drugs are pharmaceuticals with side effects that potentially harm, injure, or kill the patient to the point that they outweigh the drug’s intended benefits. Defective devices, such as faulty prosthetics, implants, pacemakers or surgical instruments can harm patients when the product is defective in the manufacturing process, design or marketing strategy.
Pharmaceutical companies are some of the largest, wealthiest, and most influential corporate entities in the world. Sanders Phillips Grossman and its predecessors have recovered over one billion dollars for injured consumers. Our firm’s history in dealing with drug and medical device injury claims has allowed us to take leadership roles in many of the national defective drug and device litigations.
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