BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS

    MDR report key: 2892800 · Received January 2, 2013

    Report

    Report Number
    1020279-2013-00004
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECT DEVICE WAS RETURNED AND EVALUATED. THE PURPOSE OF THIS INVESTIGATION WAS TO DETERMINE THE REASON FOR THE DISASSOCIATION OF THE SIZE 5-6 GENESIS II HIGH FLEX INSERT. THE INSERT WAS EXAMINED VISUALLY. THERE WAS NO DESTRUCTIVE TESTING CONDUCTED IN THIS INVESTIGATION. THE INSERT SHOWED SIGNS OF BURNISHING ON THE INFERIOR SURFACE. THE CAUSE FOR THE BURNISHING MAY BE, BUT IS NOT LIMITED TO, THE INSERT EXPERIENCING MICRO-MOTION BEFORE OR AFTER DISASSOCIATION, OR PARTICULATE DEBRIS, SUCH AS BONE CEMENT FRAGMENTS OR BONE CHIPS, CAUGHT BETWEEN THE INSERT AND THE BASEPLATE. ADDITIONALLY, THE ANTERIOR LOCKING MECHANISM SHOWED LITTLE DEFORMATION, INDICATING THAT THE INSERT WAS NOT FULLY SEATED IN THE TIBIAL BASEPLATE. ON THE SUPERIOR, ARTICULATING SURFACE THE INSERT SHOWED NO VISIBLE SIGNS OF WEAR. THE CAUSE OF DISASSOCIATION MAY HAVE BEEN DUE TO THE INSERT NOT BEING FULLY ENGAGED IN THE TIBIAL BASEPLATE AS EVIDENT OF THE LACK OF DEFORMATION ON THE ANTERIOR LOCKING MECHANISM. 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 DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917 PS GII PS HI FLEX ISRT SZ 5-6 9 JWH SMITH & NEPHEW, INC. 04BM03726

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention