BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 1964073 · Received January 19, 2011

    Report

    Report Number
    1020279-2011-00010
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 28, 2010
    Report Date
    April 13, 2011
    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 PROXIMAL ARTICULATING SURFACE OF THE GENESIS II PS HIGH FLEXION INSERT SHOWED BURNISHING AND ABRASIVE WEAR. A FULLY LOCKED INSERT WOULD TYPICALLY SHOW MILD ROUNDING THROUGHOUT THE ANTERIOR LOCKING MECHANISM. THE ANTERIOR LOCKING MECHANISM WAS PARTIALLY DEFORMED UPWARDS SUGGESTING THAT THE INSERT WAS NOT COMPLETELY ENGAGED INTO THE TIBIAL BASE AND WAS IMPINGING AGAINST THE ANTERIOR LOCKING MECHANISM OF THE TIBIAL BASE. 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. SOME WEAR WAS OBSERVED ON THE ANTERIOR AND POSTERIOR SIDES OF THE POST. THE FEATURES OBSERVED ON THE INSERT SUGGEST THAT THE COMBINATION OF PARTIAL ENGAGEMENT OF ANTERIOR LOCKING MECHANISM AND 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. CORRECTED INFORMATION: THE PART AND LOT NUMBER THAT CAME WITH THE PRODUCT WAS DIFFERENT THAN WHAT WAS PROVIDED ON THE INITIAL MDR. THEY HAVE BEEN CORRECTED IN THE APPROPRIATE FIELDS ABOVE. IN ADDITION, THE DEVICE EXPIRATION AND MANUFACTURE DATE HAVE BEEN ADJUSTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II TIBIAL INSERT JWH SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE 08LM17851

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R