BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LXH

    MDR report key: 5475478 · Received March 2, 2016

    Report

    Report Number
    1822565-2016-00553
    Event Type
    Malfunction
    Date Received
    March 2, 2016
    Date of Event
    January 26, 2016
    Report Date
    February 3, 2016
    Manufacturer
    ZIMMER INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE STRAIGHT SHELL INSERTER WAS RETURNED FOR REVIEW. VISUAL INSPECTION REVEALS THAT THE INSERTER SHOWS SIGNS OF WEAR AND TEAR AT THE IMPACTOR HANDLE, SUGGESTING EXTENSIVE USE. THE FREQUENCY OF USE OF THIS INSTRUMENT IS UNKNOWN. THE THIN PORTION OF THE LEAD THREAD HAS FRACTURED BUT REMAINS ATTACHED TO THE THREADED SHAFT OF THE HEX BOLT, CREATING A BURR. RECEIVING INSPECTION REPORT SHOWED THAT ALL DEVICES THAT WERE INSPECTED MET SPECIFICATIONS. THE REPORTED DEVICE IS USED FOR TREATMENT. REVIEW OF COMPLAINT HISTORY FOR THE PART-LOT COMBINATION OF THE REPORTED DEVICE IDENTIFIED NO ADDITIONAL COMPLAINTS. THE FAILURE OCCURS WHEN THE STRAIGHT SHELL INSERTER IS PAIRED WITH A CONTINUUM SHELL. THE LEVERING FORCE PUTS GREAT STRESS ON THE DISTAL END OF THE BOLT AND ITS INTERFACE WITH THE SHELL THREADS. A DEFINITE ROOT CAUSE CANNOT BE IDENTIFIED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THE SURGEON HAD DIFFICULTY LOOSENING THE INSERTER FROM THE IMPACTED CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131941 LXH LXH ZIMMER INC 63037846

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR