BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO PS FEMUR WAFFLE POSTS W/LFIT

    MDR report key: 1772140 · Received July 22, 2010

    Report

    Report Number
    2249697-2010-00879
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    July 1, 2006
    Report Date
    July 28, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K962152
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED. NEITHER THE DEVICE NOR ADDITIONAL INFO IS AVAILABLE FROM THE RESEARCH FACILITY. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR # 2249697-2010-00878.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE ARTHROPLASTY WAS REVISED DUE TO INSTABILITY. THE TIBIAL INSERT AND FEMORAL COMPONENT WERE REVISED. THE COMPONENTS WERE IMPLANTED IN SITU FOR 2.0 Y. UCLA SCORES FOR THIS PT WERE NOT AVAILABLE." INFO PROVIDED INDICATED THAT REPORTED DEVICES WERE IMPLANTED IN 2004 AND EXPLANTED IN 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO PS FEMUR WAFFLE POSTS W/LFIT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA K04N902

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention