BEUDAMED
    FDA Adverse Event Other Summary report: N

    3DKNEE SYSTEM

    MDR report key: 1342457 · Received March 6, 2009

    Report

    Report Number
    1644408-2009-00093
    Event Type
    Other
    Date Received
    March 6, 2009
    Date of Event
    February 16, 2009
    Report Date
    February 16, 2009
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DECREASED ROM AND UNREMITTING KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3DKNEE SYSTEM TIBIAL INSERT HSH ENCORE MEDICAL, L.P. 53888621

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention