Stryker® Orthopedics Recalls its Rejuvenate® and ABG™ II Modular-Neck Hip Stems
Firm’s Mass Tort attorneys are retaining cases involving the recalled Stryker® Orthopedics’ Rejuvenate® and ABG™ II Modular-Neck Hip Stems.
December 20, 2013
The Mass Tort Department is currently retaining cases involving the recalled Stryker Rejuvenate and ABG II Modular Hip Stems. The hip systems were sold by a company called Howmedica Osteonics Corporation d/b/a/ Stryker Orthopaedics and were voluntarily recalled in July 2012. The Rejuvenate was cleared for use by the FDA in June 2008 and the ABG II was cleared in November 2009.
The products were recalled because of the "potential risks associated with fretting and corrosion at the modular neck junction" which "may lead to adverse local tissue reactions."1 Stryker's® recalled hip stem systems have a modular design, that is, the stem and neck are two pieces.2 An April 2012 article in the Journal of the American Academy of Orthopaedic Surgeons noted potential risks of modular-neck hip stems like the Rejuvenate®, noting that "[a]lthough modularity allows extensive intraoperative flexibility, several potential and confirmed disadvantages exist, including risk of fatigue fracture and corrosion and increased systemic exposure to metal ions and debris."3
In April 2012, Stryker® issued an Urgent Field Safety Notice to the distributors, risk management personnel and surgeons utilizing the ABGTM II and Rejuvenate® modular-neck hip stems, warning of possible "excessive metal debris and/or ion generation," "fretting and/or corrosion at or about the modular neck junction," which "may lead to increased metal ion generation in the surrounding joint space."4 The Alert further cautioned that the release of the metal ions may cause "Adverse Local Tissue Reaction (ALTR)," "metallosis," "necrosis," "pain," "osteolysis," and/or possibly "result in the need for revision surgery."5
Robins, Kaplan, Miller & Ciresi L.L.P. Appointed to Plaintiff’s Steering Committee for Stryker Hip Implant Litigation
Tara Sutton, the Mass Tort Department Chair, was appointed to the Plaintiffs’ Steering Committee for the Stryker Rejuvenate and ABG II hip implant Multi-County Litigation in New Jersey. Ms. Sutton was appointed by Judge Brian R. Martinotti, who presides over the New Jersey Superior Court cases in Bergen County, N.J. Ms. Sutton is part of a group of attorneys leading the New Jersey litigation, which currently has nearly 600 cases filed against Howmedica Osteonics Corporation, based in Mahwah, NJ. Our firm has numerous cases on file in that litigation.
Robins, Kaplan, Miller & Ciresi L.L.P. Client among First to Reach Settlement in Stryker Hip Implant Litigation
In December, a Robins, Kaplan, Miller & Ciresi client became one of the first in the country to settle their Stryker hip implant lawsuit. This case was one of the first to be mediated in the court-ordered bellwether mediation program.
If you or a loved one has had a Rejuvenate® or ABGTM II hip stem component implanted, please feel free to contact our offices at 1-800-553-9910, or by email by clicking contact us. We are actively investigating these claims.
1. http://www.fda.gov/Safety/Recalls/ucm311043.htm, http://www.stryker.com/en-us/products/Orthopaedics/modularneckstems/index.html
3. Srinivasan M.D. et al., Modularity of the Femoral Component in Total Hip Arthroplasty, Journal of the American Academy of Orthopaedic Surgeons, April 2012, Vol 20. No. 4.
4. Stryker Orthopaedics Field Safety Notice RA2012-067
5. Stryker Orthopaedics Field Safety Notice RA2012-067
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