BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 1772138 · Received July 22, 2010

    Report

    Report Number
    2249697-2010-00877
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    July 1, 2009
    Report Date
    July 28, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910990
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE ARTHROPLASTY WAS REVISED DUE TO TIBIAL LOOSENING. THE TIBIAL COMPONENTS WERE REVISED. THE COMPONENTS WERE IMPLANTED IN SITU FOR 6.34 Y. (B)(6) ACTIVITY SCORES WERE NOT AVAILABLE FOR THIS PT." INFO PROVIDED INDICATED THAT REPORTED DEVICES WERE IMPLANTED IN 2003 AND EXPLANTED IN 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA T03A842

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention