BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 1202767 · Received October 13, 2008

    Report

    Report Number
    1644408-2008-00355
    Event Type
    Other
    Date Received
    October 13, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - REVISION AFTER 11 YRS OF IMPLANTATION BECAUSE OF POST FX AND MEDIAL POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM TIBIAL INSERT, P.S. 9MM HSH ENCORE MEDICAL, L.P. 136771

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention