BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 3532867 · Received December 23, 2013

    Report

    Report Number
    1818910-2013-36780
    Event Type
    Malfunction
    Date Received
    December 23, 2013
    Date of Event
    December 9, 2013
    Report Date
    February 7, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE REC'VD (B)(6) 2014 - CLINICAL REPORT STATES PATIENT WAS REVISED TO ADDRESS METALLOSIS. PART AND LOT INFORMATION WAS REC'VD. THE INVESTIGATION IS ONGOING. 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

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNK DOR: (B)(6) 2013 (RIGHT HIP). UPDATE REC'D (B)(6) 2014 - CLINICAL REPORT STATES PATIENT WAS REVISED TO ADDRESS METALLOSIS. PART AND LOT INFORMATION WAS REC'D. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS ONE OTHER REPORT AGAINST THE PROVIDED FEMORAL HEAD PRODUCT AND LOT COMBINATION, NO OTHER REPORTS WERE FOUND AGAINST THE PROVIDED INSERT. A REVIEW OF THE DHR (DEVICE HISTORY RECORD) FOR PRODUCT NUMBER 121887352 LOT NUMBER 1150784 AND PRODUCT NUMBER 136553000 LOT NUMBER 1174799 FOUND NO ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. 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 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Description of Event or Problem · 1

    UPDATE REC'D 12/11/2015 - LITIGATION PAPERS ALLEGE THE PATIENT HAS EXPERIENCED PAIN AND DISCOMFORT AS A RESULT OF HER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671867 ARTICULEZE M HEAD 36MM +8.5 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 1174799

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention