BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 2881673 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-22983
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(4) 2012 - MEDICAL RECORDS WERE RECEIVED FROM LEGAL AND ARE AVAILABLE ON AN EXTERNAL HARD DRIVE. PART/LOT INFORMATION WAS IDENTIFIED. ADDITIONALLY, IT WAS DISCOVERED THE PATIENT WAS BILATERAL. DOI: (B)(6) 2006 (LEFT HIP). DOI: (B)(6) 2008 (RIGHT HIP). 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 ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES THAT HAVE BEEN RELEASED INTO THE PATIENTS BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. DOI: UNKNOWN - DOR: UNKNOWN (UNKNOWN SIDE). (B)(6). **UPDATE** (B)(4) 2012 - MEDICAL RECORDS WERE RECEIVED FROM LEGAL AND ARE AVAILABLE ON AN EXTERNAL HARD DRIVE. PART/LOT INFORMATION WAS IDENTIFIED. ADDITIONALLY, IT WAS DISCOVERED THE PATIENT WAS BILATERAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +8.5 TOTAL HIP REPLACEMENT JDI DEPUY ORTHOPAEDICS, INC. 1818910  2748837

    Patients

    Seq Age Sex Outcome Treatment
    1 Other