BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1020279-2012-00646

    MDR report key: 2852958 · Received November 30, 2012

    Report

    Report Number
    1020279-2012-00646
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICES WERE RETURNED AND EVALUATED. THE PURPOSE OF THIS INVESTIGATION WAS TO PERFORM AN ANALYSIS OF THE RETRIEVED PROFIX POROUS HA COATED TIBIAL BASE AND PRO-FIX METAPHYSEAL TIBIAL STEM. THE IMPLANTS WERE EXAMINED VISUALLY AND WITH A STEREOSCOPE. THE PROXIMAL SURFACE OF THE TRAY HAS A SCRATCH THAT APPEARS TO HAVE BEEN CAUSED BY AN INSTRUMENT DURING EXTRACTION OF THE INSERT. THE POROUS SURFACE OF THE TRAY HAS BONE ATTACHMENTS IN THE MIDDLE PORTION OF THE TRAY. THE ANTERIOR PORTION OF THE TRAY HAS WORN AND BURNISHED BEADS ON THE ANTERIOR PORTION OF THE TRAY THAT MIGHT HAVE OCCURRED EITHER DURING EXTRACTION OR DUE TO RUBBING AGAINST BONE. STEREOSCOPIC IMAGING SHOWED THE POROUS INGROWTH SURFACE TO BE INTACT. BASED ON EXAMINATION OF THE IMPLANT THE EXACT CAUSE OF TRAY LOOSENING COULD NOT BE ASCERTAINED FROM THE INFORMATION AVAILABLE. 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 THA A REVISION WAS PERFORMED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JWH SMITH & NEPHEW, INC. 10FM09950

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention (B)(4)