BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATH(R) THREAD CUP ADAPTOR

    MDR report key: 3821963 · Received May 20, 2014

    Report

    Report Number
    3010536692-2014-00853
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    February 1, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY THE CUP IMPACTOR HAS GOTTEN STUCK ON THE ATTACHMENT DEVICE THAT SCREWS INTO THE CUP. HAPPENED TWICE, ONCE IN A CADAVER LAB, ONCE IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300189 PATH(R) THREAD CUP ADAPTOR HIP INSTRUMENT LXH MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1