BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTETRAK TIBIAL INSERT

    MDR report key: 7788312 · Received August 16, 2018

    Report

    Report Number
    1038671-2018-00678
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    November 30, 2016
    Report Date
    October 19, 2018
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ENGINEERING EVALUATION NOTED THAT THE REVISION WAS LIKELY THE RESULT OF DE-BONDING OF THE CEMENT FROM THE FEMORAL AND TIBIAL COMPONENTS, WHICH LED TO ASEPTIC LOOSENING. THE SURGEON ATTRIBUTES THE DE-BONDING TO THE TYPE OF CEMENT USED.

    Description of Event or Problem · 0

    INDEX SURGERY: (B)(6) 2015. REVISION DUE TO LOOSENING.

    Additional Manufacturer Narrative · 1

    PENDING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    INDEX SURGERY: (B)(6) 2015. REVISION DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629028 OPTETRAK TIBIAL INSERT TIBIAL INSERT JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention