BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 1530941 · Received October 27, 2009

    Report

    Report Number
    1644408-2009-00485
    Event Type
    Other
    Date Received
    October 27, 2009
    Date of Event
    September 30, 2009
    Report Date
    September 30, 2009
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - KNEE MOVING TOO FREELY, INCONSISTENT PATH/TRACKING. THE POLY WAS A 6/11 PS INSERT AND SHOWED NORMAL WEAR PATTERNS. MOVED UP TO A 6/13.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention