BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY

    MDR report key: 1001828 · Received February 25, 2008

    Report

    Report Number
    1020279-2008-00064
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    October 21, 2007
    Report Date
    February 9, 2008
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION. PER THE SURGEON, THE EVENT IS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY TIBIAL INSERT HSH SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R