BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTETRAK

    MDR report key: 2050932 · Received April 1, 2011

    Report

    Report Number
    1038671-2011-00038
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES WERE NOT RETURNED TO MFR FOR EVAL. THE DEVICE HISTORY RECORD REVIEW PROVIDES ASSURANCE THE PART WAS ACCEPTED WITH CONFORMANCE TO THE PRODUCT REQUIREMENTS.

    Description of Event or Problem · 1

    REVISION DUE TO EARLY LOOSENING. PT BEGAN HAVING PAIN WITH STANDING AND WALKING AT 3 MONTHS. SURGEON STATED THAT EXPOSURE TO THE JOINT DURING INDEX PROCEDURE WAS EXTREMELY DIFFICULT DUE TO LIMITED FLEXION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTETRAK THREE PEG PATELLA JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention