BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTETRAK 3 PEG PATELLA, CEMENTED

    MDR report key: 3981472 · Received July 25, 2014

    Report

    Report Number
    1038671-2014-00311
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    February 12, 2013
    Report Date
    September 12, 2016
    Manufacturer
    EXACTECH, INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION NOTED THAT THE REVISION WAS LIKELY THE RESULT OF JOINT LAXITY AND INSTABILITY.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    PRIMARY SURGERY (B)(6) 2012. PT REPORTS PAIN. DEVICES HAVE NOT BEEN REVISED.

    Description of Event or Problem · 1

    REVISION OF KNEE COMPONENTS DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436648 OPTETRAK 3 PEG PATELLA, CEMENTED PATELLA JWH EXACTECH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R