BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY I BCS

    MDR report key: 2920117 · Received January 17, 2013

    Report

    Report Number
    1020279-2013-00028
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT WAS RECEIVED AND EVALUATED. A DIMENSIONAL INSPECTION WAS ATTEMPTED BY THE QUALITY TEAM; HOWEVER SEVERAL OF THE DEVICE'S ATTRIBUTES WERE DEFORMED AND COULD NOT BE ACCURATELY MEASURED. THERE WERE NO MANUFACTURING OR MATERIAL DEVIATIONS NOTED DURING OUR INVESTIGATION. IN ADDITION, THE RESEARCH AND DEVELOPMENT TEAM PERFORMED A VISUAL AND MACROSCOPIC EXAMINATION WHICH REVEALED BURNISHING ON THE ARTICULATING SURFACE OF THE INSERT. BURNISHING WAS OBSERVED IN BOTH THE LATERAL AND MEDIAL COMPARTMENTS. THERE WAS ALSO DEFORMATION ALONG THE POSTERIOR RIM OF THE POST. THESE FEATURES MAY BE ATTRIBUTED TO THE REPORTED COMPLICATIONS, WHICH MAY HAVE CAUSED THE REPORTED PAIN. SAFETY AFFAIRS WILL CONTINUE TO MONITOR THIS DEVICE/ FAILURE MODE FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25568 JOURNEY I BCS JOURN ART INS BCS STD 3-4 LT 9 JWH SMITH & NEPHEW, INC. 10MM05299

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention