BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 2232096 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-16927
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    January 11, 2011
    Report Date
    August 3, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. DEPUY LEEDS REVIEWED THE DEVICE HISTORY RECORDS AND FOUND NO MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR BOTH OF THE PART AND LOT NUMBER COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT EXPERIENCED PAIN AND LACK OF MOBILITY REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +5 FEMORAL HEAD HIP IMPLANT JDI DEPUY INTERNATIONAL 2293805

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention