Drug Injury Lawyers Blog
A number of people are suing Stryker Orthopedic for personal injury and products liability related to their faulty hip implants. Their defective medical device lawsuits name the Rejuvenate and ABG II modular-neck hip stems that the manufacturer recently recalled over concerns that heavy metal poisoning could result if the implant’s cobalt and metal parts began to generate cobalt shavings when rubbing against each other.
The Stryker devices come with mix-and-match components that are supposed to help implant surgeons customize the way the pieces fit for each patient. While the Rejuvenate hip comes with 16 necks and six stems and targeted younger patients, the ABG II system comes with 10 modular necks, eight left stems, and eight right stems and are supposed to provide the minimum amount of bone stress and enhanced stability. Both hip device systems were submitted through the US Food and Drug Administration’s 501(k) program, which allows a medical device to be offered to the public sans having to make it through clinical tests if the product is proven to be similar enough to another product that has already obtained the agency’s approval.
According to the plaintiffs, the hip implant maker was negligent in the manufacture, development, testing, distribution, marketing, and sales of the Stryker hip implants. While these two hip implant systems are not considered metal-on-metal hip devices (although they do have a metal-on-metal junction because their necks are made of cobalt and chromium and the stems are coated in titanium), they do pose similar complications. The July 2012 recall of these two Stryker devices came in the wake of the US Food and Drug Administration’s receipt of about 60 adverse event reports involving them. Two months before the recall, Stryker is reported to have put out a warning to medical professionals and affected parties over concern that the rubbing together of its parts could Adverse Local Tissue Reaction, including necrosis, metallosis, osteolysis, tumor-like formations, and pain serious enough to warrant revision surgery. (Because of the nature of these particular hip systems, revision surgery can prove particularly challenging to perform and traumatic for the patient.)
