BEUDAMED
    FDA Adverse Event Other Summary report: N

    CEMENTED FINNED TIBIAL TRAY

    MDR report key: 1583810 · Received January 18, 2010

    Report

    Report Number
    1038671-2010-00004
    Event Type
    Other
    Date Received
    January 18, 2010
    Report Date
    January 18, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    A TOTAL KNEE ARTHROPLASTY WAS REVISED AND COMPONENTS WERE RETURNED TO MFR WITH NO ADD'L DETAILS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R