BEUDAMED
    FDA Adverse Event Other Summary report: N

    TIBIAL INSERT

    MDR report key: 1728314 · Received June 15, 2010

    Report

    Report Number
    1038671-2010-00081
    Event Type
    Other
    Date Received
    June 15, 2010
    Date of Event
    May 3, 2010
    Report Date
    June 15, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVAL OF THE RETURNED TIBIAL INSERT NOTED THAT THE ANTERIOR FACE HAD DAMAGE CONSISTENT WITH DEVICE REMOVAL. THE ARTICULAR SURFACE OF THE INSERT SHOWED WEAR IN THE FORM OF PITTING AND LINES RUNNING IN THE ANTERIOR/POSTERIOR DIRECTION. THE SURFACE POSTERIOR TO THE CAM HAS BEEN DULLED BY A LARGE NUMBER OF SCRATCHES.

    Description of Event or Problem · 1

    PT FELL SHORTLY AFTER TOTAL KNEE ARTHROPLASTY AND OVER TIME THE TIBIAL COMPONENT BECAME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL INSERT HSH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention