BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY BCS

    MDR report key: 1812914 · Received August 24, 2010

    Report

    Report Number
    1020279-2010-00238
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    November 15, 2009
    Report Date
    January 27, 2011
    Manufacturer
    SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART AND LOT NUMBER FOR TWO COMPLAINTS WERE INADVERTENTLY SWITCHED BY THE COMPANY REPRESENTATIVE WHEN PROVIDED TO THE REGULATORY DEPARTMENT. PRODUCT FOR THIS MDR STILL HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY BCS TIBIAL INSERT JWH SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE 07FM23871

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R