BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTETRAK

    MDR report key: 1781410 · Received July 28, 2010

    Report

    Report Number
    1038671-2010-00105
    Event Type
    Other
    Date Received
    July 28, 2010
    Date of Event
    October 27, 2008
    Report Date
    July 28, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO MFR FOR EVAL.

    Description of Event or Problem · 1

    REVISION OF TOTAL KNEE ARTHROPLASTY 15 MONTHS POSTOPERATIVELY DUE TO LOOSENING OF TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTETRAK HI-FLEX TIBIAL INSERT JWH EXACTECH, INC. 1008312

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R