BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTETRAK

    MDR report key: 3190218 · Received June 18, 2013

    Report

    Report Number
    1038671-2013-00059
    Event Type
    Other
    Date Received
    June 18, 2013
    Date of Event
    August 25, 2012
    Report Date
    May 24, 2013
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, THE DEVICE SPECIFIC IDENTIFICATION NUMBERS WERE NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    REVISION OF KNEE COMPONENTS. REASON FOR REVISION WAS NOT REPORTED TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276763 OPTETRAK KNEE COMPONENTS JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention