BEUDAMED
    FDA Adverse Event Other Summary report: N

    MJS ANATOMIC I

    MDR report key: 906984 · Received August 28, 2007

    Report

    Report Number
    1644408-2007-00147
    Event Type
    Other
    Date Received
    August 28, 2007
    Date of Event
    July 27, 2007
    Report Date
    August 28, 2007
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    PMA / PMN Number
    K012762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT REVISED TO THICKER INSERT DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MJS ANATOMIC I TIBIAL INSERT HSH ENCORE MEDICAL, L.P. U503

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization