BEUDAMED
    FDA Adverse Event Other Summary report: N

    3DKNEE

    MDR report key: 3131137 · Received May 23, 2013

    Report

    Report Number
    1644408-2013-00289
    Event Type
    Other
    Date Received
    May 23, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO INFECTION; THE SURGEON PERFORMED A POLY EXCHANGE AND DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229758 3DKNEE DCM INSERT, 11MM JWH ENCORE MEDICAL, L.P. 53888768

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention