BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 1960265 · Received January 7, 2011

    Report

    Report Number
    1644408-2011-00005
    Event Type
    Other
    Date Received
    January 7, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE TIBIAL TRAY WAS LOOSE, THE SURGEON REPLACED THE TRAY WITH A TIBIA MODULAR STEM AND AUGMENTATION BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN JWH ENCORE MEDICAL, L.P. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention