BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY

    MDR report key: 3232154 · Received July 17, 2013

    Report

    Report Number
    1020279-2013-00365
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    August 12, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    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 WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO INFECTION.

    Description of Event or Problem · 1

    PATIENT RECEIVED KNEE ASPIRATION AND SERUM INJECTIONS DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330782 JOURNEY JRNY BCS II FEMORAL OXIN RT SZ 3 JWH SMITH & NEPHEW, INC. 11MM08439

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R 74022212/10CM09038| 71932911/08KM05419| 74027214/11LM07511