BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL SPACER 12/14 +5

    MDR report key: 7526031 · Received May 18, 2018

    Report

    Report Number
    1818910-2018-59990
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    January 1, 2018
    Report Date
    April 19, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    UDI-DI
    10603295084341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    PRODUCT COMPLAINT # : (B)(4). THE INSTRUMENT ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. 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

    MEDICAL DEVICE REPROCESSING DEPARTMENT STAFF IDENTIFIED THAT RUBBER BEARING RING INSIDE THE COMPLAINED ITEMS: (2038-16-000 X 4, 2038-18-000 X 4, AND 2038-20-000 X 4) WAS WORN OUT AND NO LONGER FUNCTIONAL. THESE ITEMS HAVE BEEN DISCARDED AND REPLACEMENTS ARE REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENT DIRECTLY TO THE ACCOUNT: (B)(6). THANK YOU. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367281 TRIAL SPACER 12/14 +5 HIP INSTRUMENTS : FEMORAL TRIALS LXH DEPUY ORTHOPAEDICS, INC. 1818910 10603295084341

    Patients

    Seq Age Sex Outcome Treatment
    1