New York, NY (PRWEB) July 10, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective hip implants, is warning hip replacement patients of the potential for corrosion and adverse local tissue reactions associated with Stryker's recently recalled Rejuvenate and ABG II Modular-Neck Hip Implant Stems. According to a report released by Stryker in May, such devices, known as Modular Metal Neck Stems, are prone to corrosion, which can cause adverse local tissue reactions, resulting in "premature failure due to osteolysis, aseptic loosening and in some instances a devastating pseudotumor formation."
Stryker announced on July 6, 2012, that it was recalling its Rejuvenate and ABG II Modular-Neck Hip Implant Stems and stopping global production of the devices after post-market surveillance indicated the products were prone to corrosion and fretting that may result in adverse local tissue reactions. Affected patients may present with symptoms of pain and/or swelling at the local joint site not attributable to other conditions, such as aseptic loosening and periprosthetic sepsis, Stryker said.
The recalled Stryker Rejuvenate and ABG II hip implant components are two-part modular-neck systems that consist of a metal neck inside a metal state. The Stryker report released in May advises that patients fitted with modular-neck hip implant systems who experience persistent pain that is not linked to an infection or other explainable cause should undergo medical evaluations. These assessments “should likely include serum metal ion levels, metal hypersensitivity testing and radiographic analysis including plain radiographs and preferably a metalartifact reducing MRI," the report stated.
The problems associated with modular-neck hip implant systems, such as Stryker's Rejuvenate and ABG II components, are strikingly similar to those seen among some recipients of metal-on-metal hip replacement devices, where the ball and socket of a hip implant is made entirely of metal. A number of studies have found evidence that the recipients of metal-on-metal hip implants may face a significant risk of developing serious complications including tissue damage, device failure, need for revision surgery and long-term disability due to corrosion and shedding of metal ions from the implants. In February, for example, the British Medical Journal alerted the public about potentially high levels of metallic ions released by all-metal hip implants. The following month, the authors of a study published in The Lancet called for a ban on the devices after finding that metal-on-metal implants failed at significantly higher rates than their ceramic and plastic equivalents. In May, the Journal of Arthroplasty published a study showing that metal-on-metal implants corrode faster than metal-on-polyethylene. Most recently, a study published in Chemical Communications found possible evidence of genotoxicity in metal hip patients who experienced inflammation and subsequent revision surgery.
Last month, a U.S. Food & Drug Administration (FDA) report revealed that the agency's review of recent data suggests that metal-on-metal hip replacement systems are more likely to fail than other hip implant devices. According to the agency, metal-on-metal hip replacement devices were associated with some 16,800 adverse event reports from 2000 to 2011. In 2011 alone, metal-on-metal hip implant complaints made to the FDA totaled 12,137, compared with only 6,332 associated with other types of hip replacement systems. Most adverse events reported to the FDA in the past decade involved revision surgery to remove a failing metal-on-metal hip implant.
Last month, during a two day meeting to discuss the safety of metal-on-metal hip implants, the FDA’s Orthopaedic and Rehabilitation Devices Panel advised that metal-on-metal hip replacement recipients who were experiencing symptoms indicative of implant failure should undergo X-rays, MRIs and CT scans to detect abnormalities, and possibly blood testing for metal ions. The advisors also recommended regular X-rays for all patients, regardless of symptoms. Finally, the panel called for additional warnings to be placed on the labels of all-metal implants.
Parker Waichman LLP continues to offer free legal consultations to victims of metal-on-metal hip implant injuries. If you or a loved one experienced premature failure of your implant or other health problems associated with a metal-on-metal hip implant, please contact their office by visiting the firm's Defective Hip Implants page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding DePuy, Zimmer, Biomet and Smith & Nephew metal-on-metal hip implant lawsuits and Parker Waichman LLP, please visit: yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney