BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM -2

    MDR report key: 2991664 · Received March 6, 2013

    Report

    Report Number
    1818910-2013-00717
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 5, 2012
    Report Date
    February 8, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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 AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UDNER INVESTIGATION. DEPUY WILL NOTIFY THE FDA WITH THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A LINER WHICH HAD APPARENTLY NOT BEEN PROPERLY SEATED IN THE PRIMARY SURGERY, AND PATIENT WAS HAVING PAIN.UPDATE (B)(4) 2013- LITIGATION PAPERS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENTS BLOOD, TISSUE, AND BONE. THE FEMORAL HEAD HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95723 ARTICULEZE M HEAD 36MM -2 TOTAL HIP REPLACEMENT JDI DEPUY INTERNATIONAL 3063291

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention