BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATELLA TRIAL, 41MM DOME

    MDR report key: 6028317 · Received October 13, 2016

    Report

    Report Number
    3004153240-2016-00203
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 1, 2016
    Report Date
    November 9, 2016
    Manufacturer
    CONFORMIS, INC.
    Product Code
    LXH
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PERIODIC REVIEW OF ITEMS REMOVED FROM REUSABLE INSTRUMENT TRAYS DURING RE-PROCESSING WAS COMPLETED. REVIEW SHOWED THAT A PEG WAS BROKEN OFF OF ONE 41MM REUSABLE PATELLA TRIAL. REVIEW SHOWED THAT THE PATELLA TRIAL MAY HAVE EXPERIENCED UNEXPECTED SHEARING AND/OR A TORSIONAL LOAD. AVAILABLE INFORMATION INDICATES THAT THIS FAILURE DID NOT OCCUR DURING A SURGERY. REVIEW OF THE LOT HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    PERIODIC REVIEW OF ITEMS REMOVED FROM REUSABLE INSTRUMENT TRAYS DURING RE-PROCESSING WAS COMPLETED. REVIEW SHOWED THAT A PEG WAS BROKEN OFF OF ONE 41MM REUSABLE PATELLA TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677870 PATELLA TRIAL, 41MM DOME REUSABLE PATELLA TRIAL LXH CONFORMIS, INC. D142101

    Patients

    Seq Age Sex Outcome Treatment
    1