BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITY TOTAL KNEE

    MDR report key: 5124601 · Received September 30, 2015

    Report

    Report Number
    9614209-2015-00054
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    April 7, 2014
    Report Date
    September 28, 2015
    Manufacturer
    CORIN MEDICAL, LTD.
    Product Code
    JWH
    PMA / PMN Number
    K113060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    C-986 INITIAL REPORT. THE INSTRUMENT WAS RETURNED TO CORIN AND REVIEWED ALONG WITH THE DEVICE MANUFACTURING RECORDS. THE INVESTIGATION CONFIRMED THAT THE INSTRUMENT WAS FOUND TO MEET SPECIFICATION AND FUNCTIONALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE CONNECTION BETWEEN UNITY FEMORAL ALIGNMENT JIG AND DISTAL CUTTING BLOCK WAS LOOSE. THE PATIENT WAS UNAFFECTED AND THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644416 UNITY TOTAL KNEE TOTAL KNEE JWH CORIN MEDICAL, LTD. 123.306.00 065092-17

    Patients

    Seq Age Sex Outcome Treatment
    1