BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTETRAK

    MDR report key: 2050950 · Received April 1, 2011

    Report

    Report Number
    1038671-2011-00043
    Event Type
    Other
    Date Received
    April 1, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES WERE REQUESTED BUT HAVE NOT YET RETURNED TO MFR FOR EVAL.

    Description of Event or Problem · 1

    REVISION OF KNEE COMPONENTS DUE TO LIGAMENT LAXITY. THIS EVENT OCCURRED OUTSIDE OF THE US, IN (B)(6).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention