BEUDAMED
    FDA Adverse Event Other Summary report: N

    3D KNEE SYSTEM

    MDR report key: 1031771 · Received April 18, 2008

    Report

    Report Number
    1644408-2008-00117
    Event Type
    Other
    Date Received
    April 18, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 17, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - WHILE DOING A PATELLA RESURFACING, THE SURGEON ALSO DID 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. 53834337

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention