BEUDAMED
    FDA Adverse Event Other Summary report: N

    MJS TIBIAL INSERT

    MDR report key: 1378590 · Received May 8, 2009

    Report

    Report Number
    1644408-2009-00221
    Event Type
    Other
    Date Received
    May 8, 2009
    Date of Event
    April 12, 2009
    Report Date
    April 12, 2009
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - INFECTION, REDNESS, SORENESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MJS TIBIAL INSERT INSERT, TIBIAL #2 MJS 10DEG ANATOMIC HSH ENCORE MEDICAL, L.P. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention