BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL SPACER 12/14 +5

    MDR report key: 8570847 · Received May 1, 2019

    Report

    Report Number
    1818910-2019-92210
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 11, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295084341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY ==> EXAMINATION OF THE RETURNED INSTRUMENT FOUND THE TRIAL SPACER TO BE BROKEN. 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 D2038-20-000 WAS CRACKED AND WAS GIVEN TO THE SALES REP. ALL PIECES WERE FOUND. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363229 TRIAL SPACER 12/14 +5 HIP INSTRUMENTS : FEMORAL TRIALS LXH DEPUY ORTHOPAEDICS INC US AY0103 10603295084341

    Patients

    Seq Age Sex Outcome Treatment
    1