BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 3630785 · Received February 17, 2014

    Report

    Report Number
    1818910-2014-12758
    Event Type
    Injury
    Date Received
    February 17, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 4, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 AND ELEVATED ION LEVELS. UPDATE REC'D (B)(4) 2014 - UF (B)(4) RECEIVED FROM HOSPITAL STATES THAT PATIENT ALSO HAD "FRANK FAILURE OF THE FEMORAL STEM OR ACETABULAR SHELL." MULTIPLE ATTEMPTS TO OBTAIN INFORMATION AS TO THE NATURE OF THIS FAILURE WERE MET WITH NO RESPONSE. IT APPEARS THAT NEITHER THE STEM OR CUP WAS REMOVED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS, THE COMPLAINT WILL BE UPDATED AGAIN AT THAT TIME. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014. DOI: (B)(6) 2004; DOR: (B)(6) 2014 (LEFT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FOUND ONE ADDITIONAL COMPLAINT AGAINST THE 1183387 LOT CODE. PER (B)(4), REVISION (B)(4), A REVIEW OF THE DEVICE HISTORY RECORDS IS NO LONGER REQUIRED FOR THIS PRODUCT. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 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.

    Additional Manufacturer Narrative · 1

    UDI (10) (B)(4). EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST THE FEMORAL HEAD/LINER. PER PROCEDURE, THIS DEVICE(S) IS EXEMPT FROM DEVICE HISTORY RECORD REVIEW. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED NO OTHER REPORTS AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY STILL 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

    ADDITIONAL NARRATIVE: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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED ION LEVELS.

    Description of Event or Problem · 1

    UPDATE REC'D 1/15/2016 - LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED SERIOUS PHYSICAL INJURIES, INCLUDING ELEVATED METAL LEVELS IN THE PATIENT'S BLOOD, AND A GRINDING SENSATION AND PAIN IN THE PATIENT'S HIP. THESE INJURIES INHIBITED THE PATIENT'S ABILITY TO MOVE, AND PREVENTED HER FROM PARTICIPATING IN HER REGULAR RECREATIONAL ACTIVITIES. COMPLAINT WAS UPDATED ON 1/19/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99926 ARTICULEZE M HEAD 36MM +8.5 HIP FEM HEAD JDI DEPUY ORTHOPAEDICS INC US 1169390

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention