BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUUM, TRILOGY IT, ALLOFIT IT LINER

    MDR report key: 4801800 · Received May 26, 2015

    Report

    Report Number
    2648920-2015-00186
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    April 23, 2015
    Report Date
    April 24, 2015
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON WAS CORRECTLY FOLLOWING SURGICAL TECHNIQUE BY RUNNING HIS FINGER AROUND THE FACE OF THE SHELL, WHICH ALERTED HIM TO THE LINER NOT BEING FLUSH WITHIN THE SHELL. A ROOT CAUSE CANNOT BE STATED WITH THE INFORMATION PROVIDED. THE DEVICE WAS TO BE USED AS THE TREATMENT FOR A DISEASE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FROM THIS MANUFACTURING LOT. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE LINER WAS NOT ABLE TO BE SEATED INTO THE SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340785 CONTINUUM, TRILOGY IT, ALLOFIT IT LINER LZO LZO ZIMMER MANUFACTURING B.V. 62847519

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR