BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM -2

    MDR report key: 2880280 · Received December 19, 2012

    Report

    Report Number
    1818910-2012-29213
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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.

    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FOUND ADDITIONAL COMPLAINTS AGAINST THE 2002984 AND 1990413 LOT CODES. PER WI-3430, REVISION C, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THESE PRODUCTS IS NO LONGER REQUIRED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2006, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE MOM IMPLANT ON HER RIGHT SIDE. PATIENT SUFFERED INFLAMMATION, HIP PAIN, ELEVATED LEVELS OF METAL IONS, AND PROBLEMS SITTING, STANDING, WALKING, AND MOVING UP AND DOWN STAIRS. PATIENT NOW FACES POTENTIAL FOR A REVISION SURGERY IN THE FUTURE. UPDATE: (B)(6) 2012 - MEDICAL RECORDS WERE RECEIVED BY LEGAL. PART/LOT INFORMATION WAS IDENTIFIED. THE PATIENT WAS REVISED ON (B)(6) 2011 TO ADDRESS A FAILED HIP. A SPECIFIC REASON WAS NOT GIVEN. RECORDS ARE AVAILABLE ON DISC IF NEEDED FOR ADDITIONAL REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM -2 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 1990413

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention