BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 2052255 · Received April 12, 2011

    Report

    Report Number
    1020279-2011-00121
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    April 6, 2011
    Report Date
    July 15, 2011
    Manufacturer
    SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    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. DIMENSIONAL INSPECTION AND STEREO-MICROSCOPIC ANALYSIS WERE PERFORMED ON THE RETRIEVED INSERT. UPON VISUAL EXAMINATION, THE ARTICULATING SURFACE OF THE INSERT HAS MILD BURNISHING AND THE BACKSIDE OF THE INSERT HAS DEFORMATION AND BURNISHING DUE TO RIDING ON THE TIBIAL TRAY ANTERIOR LOCKING MECHANISM. NO NOTICEABLE CHANGES WERE OBSERVED ON THE PS POST. THE ANTERIOR LOCKING MECHANISM OF THE RETURNED INSERT HAS NO DEFORMATION PRESENT ON ONE SIDE AND MORE UPWARD DEFORMATION THAN THAT IS TYPICALLY SEEN IN LOCKED INSERT WAS OBSERVED ON THE OTHER SIDE OF THE LOCKING MECHANISM. THE POSTERIOR DOVETAILS HAVE DEFORMED GEOMETRY ON BOTH MEDIAL AND LATERAL PORTIONS DUE TO CONTACT WITH THE TIBIAL TRAY LOCKING MECHANISM AFTER DISASSOCIATION. THE CRITICAL DIMENSIONS OF THE INSERT WERE CHECKED AGAINST (B)(4) USING STANDARD OPERATOR SELF-INSPECTION INSTRUMENTS. THE PERIPHERY, A-P WIDTH, T-U DEPTH, AND HEIGHT/ANTERIOR LOCK DETAIL DIMENSIONS WERE WITHIN SPECIFICATION. THE LOCKING DETAIL, M-L WIDTH OVERALL, AND DOVETAIL DIMENSIONS COULD NOT BE MEASURED ACCURATELY DUE TO THE DEFORMATION PRESENT. THE FEATURES OBSERVED ON THE ANTERIOR LOCKING MECHANISM OF THE INSERT SUGGEST THE INSERT MAY NOT HAVE BEEN FULLY LOCKED CONTRIBUTING TO THE DISASSOCIATION OF THE INSERT FROM THE TIBIAL BASE. DAMAGE OF THE DISTAL SURFACE LIKELY OCCURRED DUE TO THE INSERT RIDING ON THE TIBIAL TRAY AFTER DISASSOCIATION.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II INSERT JWH SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION 07GM02572

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R