BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ROM*ADAPTOR HUDSON TO ZIMMER

    MDR report key: 4201878 · Received October 27, 2014

    Report

    Report Number
    1818910-2014-30683
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT; THE TABS HAVE SPREAD OUT AND HAVE WORN THE MATERIAL INSIDE OF THE TABS. PREVIOUS EVALUATIONS FOUND MISUSE AND HEAVY USAGE AS CONTRIBUTING FACTORS. THE ROOT CAUSE IS ATTRIBUTED PRODUCT WEAR OUT DUE TO HEAVY USAGE BASED ON THE OVERALL CONDITION OF THE RETURNED DEVICE. BASED ON THE ROOT CAUSE OF PRODUCT WEAR OUT, 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.

    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

    THE ADAPTOR BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682001 S-ROM*ADAPTOR HUDSON TO ZIMMER HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. SO2016202

    Patients

    Seq Age Sex Outcome Treatment
    1