BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURALOC STR CUP IMPACTOR

    MDR report key: 4222933 · Received November 4, 2014

    Report

    Report Number
    1818910-2014-31079
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 31, 2014
    Report Date
    October 31, 2014
    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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: EXAMINATION OF THE RETURNED DURALOC STR CUP IMPACTOR CONFIRMS THE REPORTED EVENT OF THE THREADS BEING CROSS THREADED. A PIN TRIAL SHELL 52 STD PROFILE (LOT-J0211) WITH DAMAGED THREADS WAS ALSO RETURNED. A COMPLAINT DATABASE SEARCH FINDS OTHER SIMILAR REPORTED EVENTS WITH THE ROOT CAUSE BEING ATTRIBUTED TO MISUSE AND WEAR OUT. THE ROOT CAUSE IS ATTRIBUTED TO MISUSE BASED ON THE DAMAGED THREADS ON BOTH RETURNED DEVICES. BASED ON THE ROOT CAUSE OF MISUSE, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE THREADS ON THE PINNACLE INSERTER HANDLE ARE CROSS THREADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707120 DURALOC STR CUP IMPACTOR HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. AG2018762

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR