BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTETRAK CEMENTED FINNED TIBIAL TRAY

    MDR report key: 1001398 · Received February 23, 2008

    Report

    Report Number
    1038671-2008-00008
    Event Type
    Other
    Date Received
    February 23, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 22, 2008
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGENT AT THE CASE REPORTED THE CAUSE OF THE LOOSENING WAS A RESULT OF CEMENT FAILURE LEADING TO SUBSIDENCE. THERE WERE NO REPORT OF EXACTECH'S DEVICE FAILING. A REVIEW OF THE MFG DEVICE HISTORY RECORD INDICATES THE DEVICE WAS MANUFACTURED TO SPECIFICATION. DEVICES WERE NOT AVAILABLE FOR ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    A TOTAL KNEE ARTHROPLASTY WAS REVISED DUE TO TIBIAL LOOSENING,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTETRAK CEMENTED FINNED TIBIAL TRAY TIBIAL TRAY HSH EXACTECH, INC. 919A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R