BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY

    MDR report key: 1060220 · Received June 13, 2008

    Report

    Report Number
    1020279-2008-00177
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    February 22, 2008
    Report Date
    June 12, 2008
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV
    Product Code
    HSA
    Product Problem
    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 RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY FEMORAL HSA SMITH & NEPHEW, INC., ORTHOPAEDIC DIV NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R