BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY

    MDR report key: 1001827 · Received February 25, 2008

    Report

    Report Number
    1020279-2008-00062
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    November 27, 2007
    Report Date
    February 18, 2008
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION
    Product Code
    HTG
    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 SYNOVITIS, ARTHROFIBROSIS, AND DISLOCATION OF THE PATELLAR COMPONENT. PER THE SURGEON, THE EVENT WAS NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY PATELLAR COMPONENT HTG SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R