BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 3944670 · Received July 18, 2014

    Report

    Report Number
    1818910-2014-23773
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    August 8, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH WAS PERFORMED. A COMPLAINT DATABASE SEARCH DID FIND ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED PRODUCT CODE AND LOT NUMBER COMBINATION(S). HOWEVER; A REVIEW OF THE DEVICE HISTORY RECORD(S) ASSOCIATED WITH THIS COMPLAINT WAS NOT REQUIRED PER WI-3430. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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. 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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. NO REASON FOR REVISION HAS BEEN IDENTIFIED AND NO FURTHER INFORMATION OR INVESTIGATIONAL INPUTS HAVE BEEN MADE AVAILABLE. A SEARCH OF THE COMPLAINTS DATABASES FINDS ONE OTHER REPORT AGAINST THE 136552000/2156118 PRODUCT/LOT CODE COMBINATION. PER PROCEDURE THIS DEVICE IS EXEMPT FROM DHR REVIEW. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE REMAINING PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    UPDATE REC'D 8/28/2014 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM DISCOMFORT, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. DOB AND DOI HAVE BEEN PROVIDED. 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.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO ELEVATED METAL IONS AND PAIN.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2015 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN, METALLOSIS, AND METAL DEBRIS. THE METALLOSIS WAS NOTED WITHIN THE HIP AND ON THE TRUNNION. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS-THE STEM IS BEING ADDED TO THE COMPLAINT. THE COMPLAINT WAS UPDATED ON: (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422794 ARTICULEZE M HEAD 36MM +5 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2156118

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention