BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION

    MDR report key: 1230283 · Received November 7, 2008

    Report

    Report Number
    1644408-2008-00418
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    PMA / PMN Number
    K923277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PT HAD RANGE OF MOTION DIFFICULTY. THE SURGEON EXCHANGED OUT THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION TIBIAL INSERT HSH ENCORE MEDICAL, L.P. 849741

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention