BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 1912894 · Received November 11, 2010

    Report

    Report Number
    1644408-2010-00606
    Event Type
    Other
    Date Received
    November 11, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K923277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - INSTABILITY IN THE KNEE, THE SURGEON PERFORMED A POLY SWAP TO A LARGER SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE TIBIAL INSERT JWH ENCORE MEDICAL, L.P. 615101

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention