BEUDAMED
    FDA Adverse Event Other Summary report: N

    MJS KNEE

    MDR report key: 1406902 · Received June 12, 2009

    Report

    Report Number
    1644408-2009-00308
    Event Type
    Other
    Date Received
    June 12, 2009
    Date of Event
    April 5, 2009
    Report Date
    April 6, 2009
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT NOT FEELING WELL, SWELLING IN LEFT KNEE, PROGRESSIVE PAIN AND UNABLE TO BEAR WEIGHT FOR 3 DAYS PRIOR TO FEELING M.O.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MJS KNEE STANDARD TIBIAL INSERT, 10 DEG. HSH ENCORE MEDICAL, L.P. T921

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention