BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY

    MDR report key: 1060221 · Received June 13, 2008

    Report

    Report Number
    1020279-2008-00176
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 8, 2008
    Report Date
    June 12, 2008
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
    Product Code
    HSA
    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 INSTABILITY AND A LOW-GRADE 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