BEUDAMED
    FDA Adverse Event Other Summary report: N

    3D KNEE

    MDR report key: 2093710 · Received April 21, 2011

    Report

    Report Number
    1644408-2011-00215
    Event Type
    Other
    Date Received
    April 21, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD AN INFECTED TOTAL KNEE SEVERAL YEARS POST TKA. ALL IMPLANTS WERE REMOVED. THE FEMORAL COMPONENT WAS FLASH-STERILIZED AND RE-IMPLANTED WITH A 3D POLY INSERT CEMENTED INTO THE TIBIA AS A TEMPORARY SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D KNEE TIBIAL INSERT JWH ENCORE MEDICAL, L.P. 764141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention