BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STEM

    MDR report key: 2885193 · Received December 17, 2012

    Report

    Report Number
    2249697-2012-02705
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    August 21, 2012
    Report Date
    November 28, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PATIENT, AS A RESULT OF A LEGAL CLAIM THAT, PLAINTIFF ALLEGES FAILURE OF THE REJUVENATE HIP THAT WAS IMPLANTED. ALLEGEDLY DIAGNOSTIC WORKUP, INCLUDING A THREE-PHASE BONE SCAN CONDUCTED ON (B)(6) 2012, REVEALED THE ABSENCE OF DEVICE LESSENING OR INFECTION. FURTHER DIAGNOSTIC WORKUP, INCLUDING MAGNETIC RESONANCE IMAGING (MRI) CONDUCTED ON (B)(6) 2012, REVEALED THE EXISTENCE OF A SIGNIFICANT FLUID COLLECTION ABOUT THE HIP PROSTHESIS. PLAINTIFF UNDERWENT A REVISION SURGERY ON (B)(6) 2012. DURING THAT SURGERY, IT WAS DISCOVERED THAT, IN FACT, THERE WAS SIGNIFICANT EVIDENCE OF HEAVY METAL TOXICITY INCLUDING A LARGE PSEUDOTUMOR FORMATION AND SOFT TISSUE NECROSIS AT THE PROXIMAL FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STEM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention