BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTETRAK

    MDR report key: 3143229 · Received May 28, 2013

    Report

    Report Number
    1038671-2013-00043
    Event Type
    Other
    Date Received
    May 28, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 28, 2013
    Manufacturer
    EXACTECH INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, THE DEVICE SERIAL AND/OR LOT NUMBERS WERE NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    REVISION OF KNEE COMPONENTS DUE TO TIBIAL SUBSIDENCE. THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES IN THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233503 OPTETRAK CRUCIATE RETAINING TIBIAL INSERT HSH EXACTECH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention