BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 867224 · Received June 14, 2007

    Report

    Report Number
    2249697-2007-00080
    Event Type
    Injury
    Date Received
    June 14, 2007
    Date of Event
    May 18, 2007
    Report Date
    May 18, 2007
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSH
    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

    THIS INFO WAS PROVIDED BY A RESEARCH CENTER. DEVICES AND ADD'L INFO ARE NOT AVAILABLE. OTHER DEVICES INVOLVED: FEMORAL COMPONENT LOT K02M621.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE ARTHROPLASTY WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT. THE TIBIAL AND FEMORAL COMPONENTS WERE REVISED. THE COMPONENTS WERE IMPLANTED IN SITU FOR 4.03 YEARS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT HSH STRYKER ORTHOPAEDICS MAHWAH NA T02M542

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention