BEUDAMED
    FDA Adverse Event Other Summary report: N

    3D KNEE SYSTEM

    MDR report key: 1063711 · Received June 20, 2008

    Report

    Report Number
    1644408-2008-00193
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - KNEE GOT INFECTED, KNEE WASH I & D AND THEN POLY WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D KNEE SYSTEM TIBIAL INSERT HSH ENCORE MEDICAL, L.P. 53910019

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention