BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAINING STEM INSERTER

    MDR report key: 4141494 · Received October 4, 2014

    Report

    Report Number
    1818910-2014-29410
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    (B)(4). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INITIAL REPORT STATED THE REPORTED DEVICE WOULD BE RETURNED FOR EXAMINATION. FOLLOW UP COMMUNICATION FOR PRODUCT RETURN WAS UNSUCCESSFUL. A COMPLAINT DATABASE SEARCH FOUND SIMILAR INCIDENTS FOR BREAKAGE AGAINST THE PROVIDED PRODUCT CODE WHICH WAS ATTRIBUTED TO MISUSE. BASED ON THE REPORTED DEVICE NOT BEING RETURNED, THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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..

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF BREAKAGE. A COMPLAINT DATABASE SEARCH ON THE PROVIDED PRODUCT CODE IDENTIFIED SIMILAR REPORTS WHICH FOUND THE INSERTER WAS USED WITHOUT THE BODY COMPONENT CONTRIBUTING TO BREAKAGE. BASED ON EVIDENCE OF THE DEVICE USED INAPPROPRIATELY, THE ROOT CAUSE IS ATTRIBUTED TO MISUSE. BASED ON THE ROOT CAUSE OF MISUSE, CORRECTIVE ACTION IS NOT NEEDED. CONTINUE TO MONITOR VIA SEP-419. 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

    WHILE TRYING TO EXPLANT A SUMMIT FEMORAL STEM, USING THE RETAINING IMPLANT INSERTER, THE INNER PIECE THAT SCREWS INTO THE IMPLANT SNAPPED IN TWO WHERE THE SOLID PART MEETS THE THREADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621159 RETAINING STEM INSERTER HIP INSTRUMENT/TRIAL LXH 1818910 DEPUY ORTHOPAEDICS, INC. ABA47129

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR