BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 4181099 · Received October 17, 2014

    Report

    Report Number
    1818910-2014-30172
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    April 30, 2018
    Report Date
    January 14, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. 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

    UDI: UNAVAILABLE. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    PER INTERNAL PROCEDURES, THE EVENT INFORMATION AND ANY INVESTIGATIONAL INPUTS RECEIVED AS PART OF REQUIRED FOLLOW UP WERE REVIEWED. FOR THIS INVESTIGATION, NO IMMEDIATE ACTION WAS REQUIRED AS NO ALLEGED DEFICIENCY WITH THE DEVICE(S) WAS IDENTIFIED. 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 ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, STIFFNESS, DECREASED RANGE OF MOTION, CLICKING SOUNDS, FEELING OF SHIFTING/MOVEMENT, MOMENTS OF DISLOCATION, AND MUSCLE SPASMS.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2015 - PFS AND MEDICAL RECORDS RECEIVED. PFS NOW ALLEGES HIGH METAL IONS. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, LAB RESULTS FROM (B)(6) 2013 INDICATED THE METAL IONS LEVELS WERE NOT ABOVE 7PPB, SO THE STEM ISN'T BEING ADDED AT THIS TIME. THE COMPLAINT WAS UPDATED ON: (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662365 ARTICULEZE M HEAD 36MM +8.5 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2313651

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention