BEUDAMED
    FDA Adverse Event Other Summary report: N

    TIBIAL INSERT

    MDR report key: 1631258 · Received March 10, 2010

    Report

    Report Number
    1038671-2010-00019
    Event Type
    Other
    Date Received
    March 10, 2010
    Date of Event
    October 5, 2009
    Report Date
    March 10, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVAL OF THE RETURNED TIBIAL INSERT IDENTIFIED EVIDENCE OF BURNISHING ON THE BOTTOM SURFACE OF THE DEVICE. THERE WAS LITTLE TO NO WEAR EVIDENT ON THE ARTICULAR SURFACE OF THE DEVICE.

    Description of Event or Problem · 1

    A KNEE ARTHROPLASTY WAS REVISED DUE TO TIBIAL LOOSENING. THIS DEVICE IS ASSOCIATED WITH THE REVISION REPORTED IN MFR REPORT #1038671-2009-00091.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R