BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD NECK SEGMENT CORAIL AMT

    MDR report key: 6623780 · Received June 8, 2017

    Report

    Report Number
    1818910-2017-19198
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Date of Event
    May 11, 2017
    Report Date
    May 11, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSTRUMENT FOUND THE REPORTED OBSERVATION UNCONFIRMED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BROKEN INSTRUMENT WAS FOUND IN QMC SPD DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403273 STD NECK SEGMENT CORAIL AMT HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 5267783

    Patients

    Seq Age Sex Outcome Treatment
    1