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Stryker Hip Replacement Problems

At Searcy Denney Scarola Barnhart & Shipley PA, we have worked with numerous clients who have suffered Stryker hip replacement problems. Our lawyers were working on these cases even before Stryker issued a voluntary recall in 2012. We have followed the regulatory history of these products, researched clinical trials and other studies involving modular hip implants, and are actively involved in the multicounty litigation that is currently underway in New Jersey. Because many of our clients have expressed interest in learning about the history of the Stryker hip implants, we have compiled a comprehensive list of resources. We urge our clients and prospective clients to take a look at these documents to learn more about the history and design of the Stryker hip implants.

1. 2013 Commentary and Perspective

  • Commentary by Douglas E. Padgett, MD, and Timothy M. Wright, PhD published in a 2013 edition of the Journal of Bone and Joint Surgery, Incorporated. The authors bring up concerns about the introduction of medical devices into the marketplace without adequate clinical testing.

2. 2013 Adverse Local Tissue Reaction Arising from Corrosion at the Femoral Neck-Body Junction

  • A series of charts that address the level of adverse reactions in 11 patients who underwent revision surgery as a result of corrosion at the modular neck-body taper junction. The majority of these patients experienced marked necrosis.

3. 2013 – Adverse Local Tissue Reaction Arising from Corrosion

  • A discussion of a study of 12 hip implants (11 patients) with adverse local tissue reactions due to corrosion at the neck-body junction. The article was published in The Journal of Bone & Joint Surgery on May 15, 2013.

4. Order of Court Designating Multi-County Litigation in New Jersey

  • An order by the Supreme Court of New Jersey, designating multicounty litigation for all state court cases involving the Stryker Rejuvenate hip stem and the ABG II Modular Hip Stem components.

5. FDA Safety Communication — Metal on Metal Hip implants

  • On January 17, 2013, the U.S. Food & Drug Administration issued a safety communication to warn about the adverse local tissue reaction (ATLR) and adverse reaction to metal debris (ARMD) associated with metal hip implants. This communication includes health recommendations for doctors and patients.

6. Simon- Plaintiff’s Reply to Defendant’s Response to Plaintiff’s Motion for Remand and for Leave to Amend the Complaint

  • A plaintiff in a Florida Stryker hip implant lawsuit filed an amendment to her complaint to include a new Orthopedic Implant Professionals, Inc. as a defendant.

7. Simon-Order Granting Plaintiff’s Motion for Remand and Leave to Amend the Complaint

  • A Florida judge granted a plaintiff’s motion to amend her Stryker lawsuit to include additional defendants.

8. Rejuvenate Total Hip System Surgical Protocol

  • A two-page overview of the Rejuvenate Total Hip System, including conditions leading to an increased risk of failure.

9. Rejuvenate Total Hip System Surgical Protocol II

  • A detailed pamphlet discussing surgical protocol for implanting the Rejuvenate Total Hip System. Includes images of the hip implant design and methods for installing the hip implant.

10. 2012 Clinical Trials — Rejuvenate Modular Outcomes Study

  • Information and eligibility requirements for the Rejuvenate Modular Outcomes Study, verified by Stryker Orthopaedics in May 2012.

11. 2009 FDA 510(k) Summary of Safety and Effectiveness

  • A copy of the 510(k) Summary of Safety and Effectiveness, submitted to the FDA in 2009, indicating a substantial equivalence of a new Rejuvenate hip component to the previously submitted Rejuvenate Monolithic Hip System.

12. 2008 FDA 510(k) Summary of Safety and Effectiveness

  • A copy of the 510(k) Summary of Safety and Effectiveness, submitted to the FDA in 2008, indicating a substantial equivalence to other commercially available hip systems, including the Secur-Fit HA Stem and the Accolade TMZF HA stems.

13. Health Canada Medical Device Recall Listing

  • The Health Canada medical device recall listing dated 5/28/12, for the Stryker Rejuvenate Modular Hip System, due to the risk of corrosion and/or fretting at the modular neck junction.

For more information about the Stryker hip replacement recall or to find out if you qualify to file a Stryker lawsuit, contact us to schedule a free consultation.