BEUDAMED
    FDA Adverse Event Other Summary report: N

    3D KNEE

    MDR report key: 1914462 · Received November 23, 2010

    Report

    Report Number
    1644408-2010-00633
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT'S KNEE WAS TIGHT. THE SURGEON SWAPPED OUT THE INSERT FOR A DIFFERENT SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D KNEE TIBIAL INSERT JWH ENCORE MEDICAL, L.P. 53983453

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention