BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE M 36MM +5

    MDR report key: 2972066 · Received February 21, 2013

    Report

    Report Number
    1818910-2013-12667
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    8010379 DEPUY INTERNATIONAL
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 SIMILAR REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    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

    REASON FOR REVISION IS OSTEOLYSIS. PATIENT HAS PRESENTED WITH A PAINFUL JOINT AND HAS REQUIRED REVISION SURGERY DUE TO OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77169 ARTICUL/EZE M 36MM +5 HEAD BALL JDI 8010379 DEPUY INTERNATIONAL 1098936

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention