BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATH(R) THREAD CUP ADAPTOR

    MDR report key: 3828091 · Received May 22, 2014

    Report

    Report Number
    3010536692-2014-00863
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY TOLERANCE TOO TIGHT BETWEEN ADAPTOR AND TIP OF IMPACTOR. VERY DIFFICULT TO DISASSEMBLE AFTER IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306362 PATH(R) THREAD CUP ADAPTOR HIP INSTRUMENT LXH MICROPORT ORTHOPEDICS INC. 1314793

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR