On July 6, 2012, the Stryker Corporation, one of the world’s largest manufacturers of medical equipment and orthopaedic devices, recalled two of its artificial hip implant systems — the Rejuvenate Modular and ABG II Modular-Neck Hip Stems. The company stopped all global sales and production of these components.
The recall came three months after Stryker issued an “Urgent Field Safety Notice” to implant surgeons and hospital risk managers pointing out the potential health hazards associated with the two products — including corrosion and “fretting,” which allows minute shards of its metallic components to leach into a patient’s tissues, bones and/or bloodstream.
Another hip stem, the Accolade TMZF, also caused problems. The company recalled those models in 2009, 2011 and 2013 because of packaging and manufacturing errors. This hip is made of the same proprietary titanium alloy as the Rejuvenate and ABG II and may corrode and fret when used with cobalt chromium femoral heads. It causes many of the same problems as the other two stems.
After a number of people suffered painful side effects like tissue and bone death at the implant site and early device failure, Stryker is now faced with mounting lawsuits filed by plaintiffs and their families.
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Why Stryker Recalled Rejuvenate, ABG II and Accolade
Stryker’s official recall announcement, dated July 6, 2012, stated that the company’s decision to “remove Rejuvenate and ABG II stems and terminate global distribution of these products comes after continued post-market surveillance.” The company’s vice president and general manager of hip reconstruction, Stuart Simpson, added: “Following this action, we will work with the medical community to better understand this matter as we continue to evaluate the data.”
The neck components of the Rejuvenate and ABG II are made of chromium and cobalt, and the stems are coated with titanium. When these parts wear against each other where the neck meets the stem, they can shed metallic debris into the body and lead to complications.
In an Urgent Field Safety Notice issued immediately before the recall, Stryker warned that post-market data revealed that the Rejuvenate and ABG II had an increased rate in Adverse Local Tissue Reaction (ALTR) – meaning complications arising from inflammation in the tissue in and around the implant.
|According to the notice, there are several potential hazards:
|Fretting and corrosion in and around the modular neck junction can release excessive metal debris into the surrounding tissue.
|Metal ions in surrounding tissues can result in inflammation leading to an immunological response including metallosis (metal poisoning), necrosis (tissue and bone death) and pain requiring revision surgery.
|Patients with metal sensitivity may have a severe allergic reaction that requires revision surgery.
|Excessive metal debris in the joint space can lead to osteolysis, also known as bone loss, and may require revision surgery.
In addition, some studies have suggested links between the absorbed metal ions and neurological and heart problems, as well as damage to the lymph nodes, spleen, liver and kidneys. Cobalt is considered especially toxic.
While the Stryker Rejuvenate and ABG II recall was voluntary, it is likely that the accumulation of adverse event reports convinced the company to issue the recall, rather than wait for it to be ordered. Hundreds of complications involving the implants were received by the Food and Drug Administration (FDA) in 2012.
This is not the first time Stryker has recalled a hip implant. In 2008, the company recalled its Trident Acetabular PSL and Trident Hemispherical cups, manufactured at a facility in Ireland, and in April 2012, it recalled its Accolade Femoral stem, due to high revision rates. Stryker refuses to comment on the actual failure and revision rates of the Rejuvenate and ABG II devices.
Stryker Recalls Lead to Lawsuits
Soon after Stryker issued the recall, a number of people who suffered complications like fractured hips, loss of tissue and bone, as well as debilitating pain filed lawsuits against the device manufacturer.
One of these people is Branko Obradovic. Obradovic filed a lawsuit after his Stryker hip failed soon after it was implanted, and he ended up having revision surgery 15 months after. Now, he can barely stay seated for very long and says just getting out of a car is an ordeal. “I’m very angry about the whole thing,” he told the Palm Beach Post. “They should know what they are putting in someone’s body.”
Lawsuits filed against Stryker allege that the company was negligent in failing to warn the public about the high rate of failure. They also accuse the company of making fraudulent claims that the titanium and cobalt chrome neck and stem in the Rejuvenate and ABG II were resistant to fretting and corroding.
People who have had hip replacement surgery should carefully check their medical records to see if these implants were used. It is possible that a Stryker hip component may be listed under a different product name. If you need help identifying your implant, Drugwatch can help. Our Patient Advocates are available 7 days a week to walk you through the process. If you need information to see if filing a lawsuit is the right choice for you, let us help you.