BEUDAMED
    FDA Adverse Event Other Summary report: N

    3D KNEE SYSTEM

    MDR report key: 1289615 · Received January 13, 2009

    Report

    Report Number
    1644408-2009-00005
    Event Type
    Other
    Date Received
    January 13, 2009
    Date of Event
    December 30, 2008
    Report Date
    December 30, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - INSTABILITY DURING FLEXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D KNEE SYSTEM TIBIAL INSERT, DCM HSH ENCORE MEDICAL, L.P. 446142

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention