BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 1840863 · Received September 22, 2010

    Report

    Report Number
    1020279-2010-00268
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 25, 2010
    Report Date
    October 14, 2010
    Manufacturer
    SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS INVESTIGATION WAS TO DETERMINE THE CAUSE FOR THE DISASSOCIATION OF THE TIBIAL INSERT FROM THE TIBIAL BASE PLATE. MACROSCOPIC PHOTO ANALYSIS WAS PERFORMED ON THE RETRIEVED INSERT. THE PROXIMAL ARTICULATING SURFACE OF THE INSERT SHOWED BURNISHING AND MILD ABRASIVE WEAR. IMPINGEMENT, DAMAGE AND BURNISHING WERE OBSERVED ON THE ANTERIOR SIDE OF THE POST. MILD ROUNDING TYPICALLY SEEN IN A FULLY LOCKED INSERT WAS OBSERVED ON BOTH SIDES OF THE ANTERIOR LOCKING MECHANISM. A CURVED AREA OF WEAR AND DEFORMATION DUE TO THE INSERT RIDING ON THE TIBIAL TRAY ANTERIOR LOCKING MECHANISM AFTER DISASSOCIATION WAS OBSERVED ON THE DISTAL SURFACE. SEVERE DEFORMATION AND DAMAGE OF THE DOVETAILS DUE TO THE INSERT RIDING ON THE TIBIAL TRAY WAS OBSERVED. THE FEATURES OBSERVED ON THE INSERT SUGGEST THAT ANTERIOR TIBIAL POST IMPINGEMENT MAY HAVE CONTRIBUTED TO THE DISASSOCIATION OF THE INSERT FROM THE TIBIAL BASE. DAMAGE OF THE DISTAL SURFACE OCCURRED DUE TO THE INSERT RIDING ON THE TIBIAL TRAY AFTER DISASSOCIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED, DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II TIBIAL LNSERT JWH SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE 10AM01155

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R