BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 3052028 · Received April 11, 2013

    Report

    Report Number
    1818910-2013-02225
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    April 9, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO REPORTS AGAINST THE PROVIDED PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. NO OTHER ADDITIONAL INFORMATION WAS RECEIVED THAT WOULD AFFECT THE PREVIOUS INVESTIGATION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. MONITOR THROUGH TREND ANALYSIS VIA (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    BLOOD TEST SHOWING HIGH LEVELS OF COBALT CHROMIUM, AND PATIENT HAD TO HAVE FLUID ON THE HIP REMOVED. PATIENT REVISED. UPDATE (B)(6) 2013: PRODUCT/LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156589 ARTICULEZE M HEAD 36MM +5 HEAD BALL JDI DEPUY INTERNATIONAL 2814909

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention