BEUDAMED
    FDA Adverse Event Other Summary report: N

    PS TIBIAL INSERT

    MDR report key: 1698901 · Received May 21, 2010

    Report

    Report Number
    1038671-2010-00071
    Event Type
    Other
    Date Received
    May 21, 2010
    Date of Event
    March 30, 2010
    Report Date
    April 21, 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

    RETURNED DEVICE IS CURRENTLY UNDERGOING ENGINEERING EVALUATION. THE DEVICE HISTORY RECORD REVIEW PROVIDES ASSURANCE THE PART WAS ACCEPTED WITH CONFORMANCE TO THE PRODUCT REQUIREMENTS.

    Description of Event or Problem · 1

    REVISION OF TOTAL KNEE ARTHROPLASTY APPROX 9 MONTHS POST OPERATIVELY DUE TO TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PS TIBIAL INSERT NONE HSH EXACTECH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention