Within a few months after the Stryker hip replacement system was recalled, plaintiffs’ lawyers have filed the first lawsuits against the hip implants’ manufacturer, Howmedica Osteonics Corp. According to plaintiffs’ attorneys, the alleged problems with the Stryker Rejuvenate Modular and ABG II involve the stem of the products, rather than the ball and socket join. As a result, injuries have been more significant and the fix more difficult.
The ‘dual modular’ system of the Stryker products have two places where the pieces fit into each other: one between the stem and neck, and the second between the neck and ball. According to attorneys, the device was marketed as giving more flexibility to orthopedic surgeons. In June 2008, the Stryker implants received FDA clearance and approximately 30,000 devices were implanted worldwide.
By July 2012, Howmedica posted on the company’s website the reason for recalling the Stryker Modular and Rejuvenate ABG II: “[There is a] potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling”. Patients are just now getting recall notices.
Early lawsuits claim that the arrangement of metals in the product causes corrosion of the piece that is inserted into the femur. Corrosion occurs due to the dissimilar metals between the neck and the stem. Because the problems involve the stem portion that goes into the femur, corrective surgery is very complex. Reportedly in one case involving plaintiff Diane Pingel, after fracturing her femur, she underwent an extensive surgery, followed by two additional complicated operations four weeks later, and eight weeks of rehabilitation. The metal combination can cause other problems – possible growth of pseudotumors, where tissue grows around the device; mononucleosis-like malaise, the taste of metal in one’s mouth, migraine headaches, and numb left arms; and long-term metal poisoning.
At any point during the design and manufacturing process, significant failures may contribute to hip implant hazards, including (1) missteps during the early design stages; (2) inadequate testing to ensure safe performance; and (3) marketing efforts that include inadequate instructions and warnings, or even fail to include any relevant cautions. Even one act of negligence during the process from a product’s conception to its sale can cause catastrophic injuries and wrongful death once the product reaches unsuspecting consumers.
If you or a family member have suffered significant personal injuries as the result of a defective product or negligence, contact the law office of Swartz & Swartz, P.C. Call (617) 742-1900 in the Boston area, or for clients in greater Massachusetts, New England, or other states across the U.S., call toll-free at 1-800-545-3732.