Hip Replacement Recall Lawsuit Stryker Biomet Wright Smith Nephew Hip Implant Recall Lawsuit Attorney
Stryker Rejuvenate Hip Recall Depuy Hip Replacement Implant Recall Lawsuit Attorney
Stryker Orthopaedics has announced a national recall of its Rejuvenate Modular and ABG II brands of neck stems used for metal hip implants. The Michigan-based orthopedic implant manufacturer has terminated the sale of the two modular-neck stems used for hip replacement surgeries following discovery of potential risks. According to the information on the Stryker website, the devices are found to have “potential 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. and ” In June 2012, Stryker recalled Rejuvenate hip implants in Canada for similar reasons. With 16 percent share of global orthopedic market, Stryker manufacturers a number of primary acetabular, femoral, and restoration hip implant components. Hip replacement implant recall lawsuit attorneys have filed hip implant lawsuits against Depuy Hip , Stryker Hip , Smith And Nephew Hip , Wright Medical Hip , Biomet and Stryker.
The July 4 recall was prompted by more than 60 complaints of hip replacement failure, including 40 reports of injuries related to Rejuvenate modular-neck stem since January 2012, against Stryker hip implants filed with the FDA adverse impact reporting system. Post-marketing surveillance data shows the patients implanted with these hip neck-stem implants and metal on metal hip replacement implants such as the Depuy ASR are at increased risk of metallosis because of release of metal particles into human blood streams following corrosion and erosion of these devices. Design problems cause metal hip components in these neck stems to rub against each other leading to discharge of cobalt and chromium into the blood. The unacceptable level of corrosion also renders Rejuvenate Modular and ABG II hip implant neck stems ineffective and put patients at the enhanced risk of device failure, pseudotumor formation, tissue destruction, infection, and bone necrosis. As with other metal hip implant recalls , the depuy and biomet hip lawsuits also focus on the similar metal poison from these recalled hip implants.
Stryker , Depuy , Biomet , Smith & Nephew Hip Implant Replacement Recall Complaints and Warnings
Stryker introduced Rejuvenate Modular hip implants in February 2010 asserting that the new product would provide improved intraoperative efficiency and flexibility. The modular hip system was approved by the FDA through its 510(k) clearance program, which does not mandate any safety trials for products “substantially equivalent” to those already in the market. Stryker claimed that Rejuvenate Modular hip implants were similar to the Profemur to ease regulatory approval. The Wright Profemur has been subject to a number of attorney lawsuits, citing early failure and metallosis similar to the issues found in other metal hip implants and at the root of most hip implant recall lawsuits from a doctor and attorney perspective.
In November 2007, the FDA warned Stryker about poor and unsanitary conditions at its Mahwah manufacturing facility, New Jersey, following an inspection of the plant. The regulator had been receiving complaints about product failures and a range of associated health problems since 2005. The admonition letter held deficient conditions responsible for faulty Stryker hip implants. The inspection team also discovered contamination at the plant by Staphylococcus bacteria, which can cause staph infections.
In January 2008, Stryker recalled two of its hip implant components, Acetabular PSL Cup and Hemispherical Cups, marketed under the Trident brand. The recall was made following growing concerns of contamination of these hip implants by “manufacturing residuals” beyond the permissible standards.
In March 2009, the American Academy of Orthopedic Surgeons recommended against using Stryker Trident cup hip implants because of their squeaking problems.