BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAINING STEM INSERTER

    MDR report key: 4192655 · Received October 22, 2014

    Report

    Report Number
    1818910-2014-30430
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. 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 DEVICE CONFIRMED THE REPORTED EVENT. THE STEM INSERTER'S THREADED DISTAL END IS BENT ALONG WITH DAMAGED THREADS. THE OVERALL CONDITION OF THE DEVICE SUGGESTS HEAVY USAGE. A COMPLAINT DATABASE SEARCH IDENTIFIED SIMILAR REPORTS FOR THE PROVIDED PRODUCT CODE WHICH FOUND MISUSE AND OR PRODUCT WEAR OUT DUE TO HEAVY USAGE AS THE ROOT CAUSE. THE ROOT CAUSE IS ATTRIBUTED TO MISUSE ALONG WITH HEAVY USAGE AS A CONTRIBUTING FACTOR. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT NEEDED. 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.

    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.

    Description of Event or Problem · 1

    DEFORMATION OF INNER PART (THREADED ROD) OF THE INSTRUMENT. PROCEDURAL STEP UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672537 RETAINING STEM INSERTER HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 ABB74220

    Patients

    Seq Age Sex Outcome Treatment
    1