BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 2881302 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-29216
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    March 30, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    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

    **UPDATE** (B)(4) 2012 - MEDICAL RECORDS WERE RECEIVED. PART/LOT INFORMATION WAS IDENTIFIED. MEDICAL RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF NEEDED FOR FURTHER REVIEW. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT OVER TIME THE KNOWN AND COMMON PROBLEM OF NATURAL BIOLOGIC CORROSION AND FRICTION WEAR CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENTS BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. IT IS FURTHER ALLEGED SINCE IMPLANTATION, PATIENT HAS EXPERIENCED SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS RIGHT THIGH, RIGHT HIP AREA AND GROIN. IT IS ALSO ALLEGED HE FEELS DISCOMFORT WHEN SITTING FOR PERIODS OF TIME. **UPDATE** (B)(6) 2012 - MEDICAL RECORDS WERE RECEIVED. PART/LOT INFORMATION WAS IDENTIFIED. MEDICAL RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF NEEDED FOR FURTHER REVIEW.

    Description of Event or Problem · 1

    THERE WERE NO NEW ALLEGATION AND REVISION REPORTED. ADDED STEM DUE TO PREVIOUSLY ALLEGED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS. ADDED LAWYER IN THE ASSOCIATED CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS, INC. 1818910 1187148

    Patients

    Seq Age Sex Outcome Treatment
    1 Other