BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +12

    MDR report key: 2922401 · Received January 18, 2013

    Report

    Report Number
    1818910-2013-00847
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 20, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. NOT RETURNED.

    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 COMBINATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. THE PART AND LOT COMBINATION WAS NOT PROVIDED FOR THE METAL HEAD. 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 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 THAT CORROSION AND FRICTION WEAR CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENTS BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. IT IS FURTHER ALLEGED THAT THE PATIENT HAS EXPERIENCED SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HRT RIGHT THIGH AND HIP AREA, AS WELL AS HER GROIN. PATIENT HAS EXPERIENCED EPISODES OF A GRINDING AND POPPING SENSATION IN HER RIGHT HIP. UPDATE: (B)(6) 2012 - (B)(4) AND MEDICAL RECORDS WERE RECEIVED FROM LEGAL. PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27987 ARTICULEZE M HEAD 36MM +12 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 2887051

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other