BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 2013086 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-02966
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    February 7, 2010
    Report Date
    January 26, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: LITIGATION PAPERS WERE RECEIVED ALLEGING METALLOSIS AND ASEPTIC LYMPHOCYTE DOMINATED VASCULITIS ASSOCIATED LESION (ALVAL). DOI: (B)(6) 2004 (RIGHT SIDE). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH STILL FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THIS MATTER IS IN LITIGATION. FOLLOW-UP ACTIVITIES ARE BEING PERFORMED BY THE DEPUY LEGAL TEAM. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    PT REVISED FOR POSSIBLE INFECTION AND POSSIBLE OSTEOLYSIS. LITIGATION PAPERS WERE RECEIVED ALLEGING METALLOSIS AND ASEPTIC LYMPHOCYTE DOMINATED VASCULITIS ASSOCIATED LESION (ALVAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +5 87JDI 87LPH JDI DEPUY INTERNATIONAL NA 1237340

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention