BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO TS MOD. TIB. TRAY

    MDR report key: 1790160 · Received August 3, 2010

    Report

    Report Number
    2249697-2010-00984
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K032479
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. NEITHER THE DEVICE NOR ADDITIONAL INFORMATION IS AVAILABLE FROM THE RESEARCH FACILITY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME EVENT AS THE FOLLOWING MFR NUMBER # 2249697-2010-00983.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE ARTHROPLASTY WAS REVISED DUE TO PAIN. THE TIBIAL COMPONENTS WERE REVISED. THE COMPONENTS WERE IMPLANTED IN SITU FOR 0.7 Y. THE PATIENT PRESENTED WITH A (B)(6) SCORE OF 3 THREE MONTHS PRIOR TO REVISION SURGERY AND MAXIMUM SCORE OF 8." INFORMATION PROVIDED INDICATED THAT REPORTED DEVICES WERE IMPLANTED IN 2006, AND EXPLANTED IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO TS MOD. TIB. TRAY IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA T05T840

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention