BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 1202882 · Received October 17, 2008

    Report

    Report Number
    1644408-2008-00376
    Event Type
    Other
    Date Received
    October 17, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 8, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    PMA / PMN Number
    K923277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - INFECTION OF THE KNEE AFTER TKA. SURGEON IRRIGATED AND SWAPPED OUT POLY INSERT FOR SAFE MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM PRIMARY INSERT HSH ENCORE MEDICAL, L.P. 53885894

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention