BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY

    MDR report key: 1862301 · Received October 8, 2010

    Report

    Report Number
    1020279-2010-00285
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 27, 2010
    Manufacturer
    SMTIH & NEPHEW, INC. BROOKS MANUFACTURING SITE
    Product Code
    HRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FEMORAL COMPONENT APPEARED TO BE WELL FIXED. BURNISHING SEEN IN THE FIXATION AREA OF THE TIBIAL BASE INDICATES A DEGREE OF LOOSENING. THE INDENTATIONS AND ABRASIVE WEAR PATTERNS OBSERVED ON THE RETRIEVED INSERT LIKELY RESULTED FROM THIRD BODY DEBRIS SUCH AS BONE AND/OR BONE CEMENT, HOWEVER NO SUCH DEBRIS WAS FOUND ON THE ARTICULATING SURFACE. THE WEAR AND POST CONTACT LOCATIONS OBSERVED ON THE INSERT SUGGEST THAT A COMBINATION OF INTERNAL ROTATION OF THE INSERT AND/OR EXTERNAL ROTATION OF THE FEMORAL COMPONENT MAY HAVE OCCURRED.

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA BLOOD GLUCOSE RESULTS OF 6.0 MMOL/L, 8.2 MMOL/L, AND 11.2 MMOL/L, EACH RESULT 1 MINUTE APART. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED FOR REASONS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY FEMORAL COMPONENT HRY SMTIH & NEPHEW, INC. BROOKS MANUFACTURING SITE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R