BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STEM

    MDR report key: 2885207 · Received December 17, 2012

    Report

    Report Number
    2249697-2012-02696
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    July 18, 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 INFO IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFO IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PT, AS A RESULT OF A LEGAL CLAIM THAT, PLAINTIFF ALLEGES FAILURE OF THE REJUVENATE HIP THAT WAS IMPLANTED. ALLEGEDLY AFTER SYMPTOMS WORSENED, 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