BEUDAMED
    FDA Adverse Event Other Summary report: N

    3D KNEE

    MDR report key: 2093717 · Received April 21, 2011

    Report

    Report Number
    1644408-2011-00220
    Event Type
    Other
    Date Received
    April 21, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    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 - THE PT DEVELOPED AN INFECTION AT THE SURGICAL SITE. THE SURGEON DECIDED TO BRING THE PT BACK FOR AN IRRIGATION AND DEBRIDEMENT. THE ORIGINAL INSERT WAS REMOVED AND A SMALLER SIZE WAS IMPLANTED TO HELP FACILITATE RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D KNEE DCM TIBIAL INSERT JWH ENCORE MEDICAL, L.P. 59600107

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention