BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 1880475 · Received October 13, 2010

    Report

    Report Number
    1644408-2010-00531
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K923277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY- PATIENT DEVELOPED AN INFECTION ONE YEAR POST OP, DRUG AND ALCOHOL ADDICTION. PERFORMED POLY EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE INSERT JWH ENCORE MEDICAL, L.P. 53971931

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention