BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII STANDARD TIBIA B

    MDR report key: 2860559 · Received December 6, 2012

    Report

    Report Number
    1020279-2012-00657
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS RETURNED AND EVALUATED. A DIMENSIONAL INSPECTION WAS ATTEMPTED; HOWEVER SEVERAL OF THE DEVICE'S ATTRIBUTES WERE DEFORMED AND COULD NOT BE ACCURATELY MEASURED. THERE WERE NO MANUFACTURING OR MATERIAL DEVIATIONS NOTED DURING OUR INVESTIGATION. THE RESEARCH AND DEVELOPMENT TEAM PERFORMED A MACROSCOPIC EXAMINATION THAT REVEALED DAMAGE ON THE ARTICULATING SURFACE OF THE INSERT WAS LIKELY CAUSED BY THIRD-BODY DEBRIS IN THE JOINT SPACE; WHICH MAY BE AN INDICATION OF IMPLANT LOOSENING. DEFORMATION NEAR THE ANTERIOR SURFACE IS LIKELY DUE TO REMOVAL OF THE INSERT. 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 LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GII STANDARD TIBIA B GNS II CMT TIB SIZE 7 {} LEFT JWH SMITH & NEPHEW, INC. 11HM07195

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention (B)(4)