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.)
Other side effects that have been associated with a Stryker hip device include vision problems, heart issues, neurological complications, lymph node injuries, spleen injuries, and damage to the kidney. If you believe that your injuries or health complications are a result of a failed medical device, do not hesitate to contact an experienced products liability law firm today.
In addition to individual Stryker hip defect lawsuits, a class action has already been filed in federal court. Raymond Chasse, Jr. submitted his class action complaint in the U.S. District Court for the District of Massachusetts for residents in the state that have, since 2003, suffered device failures. His lawsuit, however, involves another Stryker product, the Trident Hemispherical Acetabular Shells. Chasse estimates that there will be about 40 plaintiffs joining his case.
Stryker Initiates Voluntary Product Recall of Modular-Neck Stems Action Specific to Rejuvenate and ABG II Modular-Neck Stems, FDA, July 6, 2012
Plaintiff Seeks Class Status for Mass. Recipients of Stryker Trident Hip Systems, Harris Martin Publishing, September 20, 2012
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Settlement Reached in Vaginal-Mesh Implant Case, Boston Injury Lawyer Blog, August 2, 2012
Defective Medical Device?: DePuy Hip Replacement Recall Leads to Products Liability Lawsuits, Boston Injury Lawyer Blog, September 29, 2010
Severe Skin Reactions Caused by Stevens-Johnson Syndrome are Linked to Different Prescription and OTC Medications, Drug Injury Lawyers Blog, August 29, 2012