BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY BCS

    MDR report key: 2133741 · Received June 20, 2011

    Report

    Report Number
    1020279-2011-00206
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 20, 2011
    Manufacturer
    SMTIH & NEPHEW, INC. ORTHOPAEDIC DIVISION
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE PATIENT HAS BECOME A RECURRENT DISLOCATOR WITH A LIGAMENT LAXITY DISEASE. THE SURGEON BELIEVES THE DISLOCATIONS ARE SELF-INFLICTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY BCS TIBIA BASE NP RT SZ 3 JWH SMTIH & NEPHEW, INC. ORTHOPAEDIC DIVISION 08KM10073

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R PART # 74021113, LOT # 08DM23758| PART # 74023238, LOT # 07HM01727