History of the Stryker ABGII Modular-Neck Stems
Although the Stryker ABGII and the Rejuvenate are not “true” metal-on-metal hip implants in that they do not implement a femoral head and acetabular cup, the necks are nonetheless manufactured of cobalt and chromium and the stems are titanium coated. The design is known as a modular design and gives surgeons additional options during implantation to fit the hip implant to the patient’s specific anatomy. Additionally, there is a metal-on-metal neck juncture and metal trunnions located on either end of the neck. This means that the ABGII has many of the same risks of metallosis and metal toxicity as other metal-on-metal hip implants. Both the ABGII and the Rejuvenate were recalled in July of 2012, after an urgent safety alert was issued to hospitals and surgeons just three months earlier advising them of potential risk factors.
The hazards of the ABGII were listed as excessive metal debris or ion generation caused by fretting and corrosion at the metal modular neck stems. At the time of the ABGII recall, numerous adverse reports had come into the FDA regarding symptoms of metallosis and metal toxicity which led to failure of the implant and the necessity of revision surgery. Unfortunately, replacement surgery in the Stryker models is much more complicated and dangerous than for many other hip implants due to its design. When the hip system is implanted into the body the neck stems go deeply into the femoral bone, therefore when it must be removed it is literally dug out by the surgeon. This can lead to bone fracture or shattering of the femur. Replacement surgery can cause many subsequent problems as well as keeping the patient away from work for up to six weeks.
Has a Stryker Hip Replacement Damaged Your Health?
Both before and after the recall, hundreds reports of adverse symptoms related to the ABGII and Rejuvenate had come into the FDA. Even though it was initially believed that metallosis was not possible from the Rejuvenate or ABGII due to the fact that both designs use a ceramic femoral head, this was found not to be true.
Symptoms of Metallosis from a Stryker Hip Replacement
When metal ions are released into the body, they will either lodge in the surrounding hip tissues or they will travel to the bloodstream. As they burrow into the hip tissue, inflammation can occur which causes the implant recipient significant levels of pain. As the metallosis progresses, tissue necrosis and bone loss can occur as well as the formation of pseudo-tumors. When enough of the bone and tissue is gone, the implant will loosen and, ultimately, fail. Failure of the implant will require immediate revision surgery. Metal toxicity is very serious and can lead to symptoms of hearing and vision loss, gastrointestinal disorders, neurological issues, cardiovascular events, thyroid and renal issues, depression, irritability, anxiety, vertigo and even the disruption of the body’s DNA.
How a Stryker ABGII Modular Recall Lawyer Can Help
Although many patients have already sought to file lawsuits regarding the harm they have suffered from the ABGII and Rejuvenate, many have been turned away due to the fact that the implant is not a true all-metal device. Since the recall led to the link to metal corrosion as being as responsible for metallosis and metal toxicity as metal shear, patients who were initially turned away should consider filing a Stryker Hip Replacement Lawsuit, as those patients’ lives will never be the same following their implantation of a Stryker ABGII or Rejuvenate hip device.
Stryker Corporation generates over $8 billion dollars in annual sales across the globe with a large amount of that coming from the sales of their hip implants. The Rejuvenate gained FDA approval in 2008 while the ABGII was approved in 2009. Both hip implants gained approval through the controversial 510(k) approval process. This means both hip implants were marketed without benefit of human testing because DePuy could claim their device was substantially equivalent to a device which had already been approved. Because product safety was not required to be tested prior to implanting the devices in human patients, the flaws were only discovered after the implants had been placed into thousands of human beings. Stryker issued a recall for the ABGII and the Rejuvenate this past July, 2012. The recall came on the heels of a safety alert sent out the prior April which stated both models had the potential of fretting and corrosion which could damage the health of recipients. Lawyers around the nation are gearing up to file numerous lawsuits which are expected following the recall. Attorneys who work in the product liability area understand the many complexities of such lawsuits.