BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 2881521 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-29217
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 20, 2012
    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

    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

    UPDATE - (B)(4) 2012 - MEDICAL RECORDS WERE RECEIVED. PART/LOT INFORMATION WAS RECEIVED. MEDICAL RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF FURTHER REVIEW IS REQUIRED. DOI: (B)(6) 2004 (LEFT). DOI: (B)(6) 2004 (RIGHT). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL 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 IDENTIFY A ROOT CAUSE CORRECTIVE ACTION WAS NOT ESTABLISHED. 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: ON OR ABOUT (B)(6) 2004, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HER LEFT SIDE, AND ON OR ABOUT (B)(6) 2004, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HER RIGHT SIDE. PATIENT HAS LARGE AMOUNTS OF COBALT-CHROMIUM METAL IONS AND PARTICLES IN HER BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANTS. PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HER THIGHS AND GROIN. SHE ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HER HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANTS. UPDATE: (B)(6)2012 - MEDICAL RECORDS WERE RECEIVED. PART/LOT INFORMATION WAS RECEIVED. MEDICAL RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF FURTHER REVIEW IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +1.5 FEMORAL HEAD JDI DEPUY INTERNATIONAL 1218604

    Patients

    Seq Age Sex Outcome Treatment
    1 Other