BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURALOC STR CUP IMPACTOR

    MDR report key: 6246899 · Received January 12, 2017

    Report

    Report Number
    1818910-2017-10771
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Date of Event
    December 19, 2016
    Report Date
    December 19, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMS THE HANDLE OF THE INSTRUMENT IS CRACKED. THE OVERALL CONDITION OF THE INSTRUMENT INDICATES IT HAS BEEN WELL USED OVER TIME. THE DATE CODE AG0910 INDICATES THE INSTRUMENT WAS MANUFACTURED IN SEPTEMBER OF 2010 AND IS OVER 6 YEARS OLD. BASED ON THE AGE AND OVERALL CONDITION OF THE INSTRUMENT THE ROOT CAUSE IS ATTRIBUTED TO WEAR OUT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.

    Description of Event or Problem · 1

    THE HANDLE ON THE CUP INSERTER IS SPLIT LENGTH WISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28228 DURALOC STR CUP IMPACTOR HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. AG0910

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR