BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY BCS

    MDR report key: 2150587 · Received July 6, 2011

    Report

    Report Number
    1020279-2011-00241
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    September 7, 2010
    Report Date
    July 6, 2011
    Manufacturer
    SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY BCS JOURNEY TIBIA BASE NP LT SZ 7 JWH SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION 08CM09874

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R PART # 74023281 / LOT # 06CM08642| PART # 74024835 / LOT # 08DM24394| PART # 74021126 / LOT # 08EM04854