BEUDAMED
    FDA Adverse Event Other Summary report: N

    3D KNEE SYSTEM

    MDR report key: 1063713 · Received June 20, 2008

    Report

    Report Number
    1644408-2008-00195
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 29, 2008
    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 - PT HAD INFECTION AND NEEDED TO WASH OUT KNEE AND DO A POLY EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D KNEE SYSTEM TIBIAL INSERT HSH ENCORE MEDICAL, L.P. 455012

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention