BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1503443 · Received October 9, 2009

    Report

    Report Number
    1020279-2009-00718
    Event Type
    Injury
    Date Received
    October 9, 2009
    Report Date
    October 8, 2009
    Manufacturer
    JOURNEY ONI
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED, DUE TO FRACTURE OF THE TIBIAL BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TIBIAL BASEPLATE / JWH JWH JOURNEY ONI NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R