BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTETRAK HI-FLEX TIBIAL INSERT

    MDR report key: 1242526 · Received November 21, 2008

    Report

    Report Number
    1038671-2008-00068
    Event Type
    Other
    Date Received
    November 21, 2008
    Date of Event
    October 10, 2008
    Report Date
    November 21, 2008
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A TOTAL KNEE ARTHROPLASTY (TKA) WAS REVISED APPROX 14 MONTHS POST OPERATIVELY DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTETRAK HI-FLEX TIBIAL INSERT TIBIAL INSERT HSH EXACTECH, INC. 244-23-09

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R