BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 3893075 · Received June 24, 2014

    Report

    Report Number
    1818910-2014-21888
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    February 15, 2012
    Report Date
    June 16, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PFS AND MEDICAL RECORDS RECEIVED. IT SHOULD BE NOTED THESE RECORDS WERE RECEIVED THROUGH A PFS. THIS COMPLAINT IS NOT YET LEGAL. PFS ALLEGES PAIN, DISFIGUREMENT, AND DECREASED RANGE OF MOTION. AFTER REVIEW OF THE MEDICAL RECORDS THERE WAS NO MENTION OF METALLOSIS. IT DID INDICATE THE CUP HAD SOME SLIGHT RETROVERSION SO IT WAS REVISED. (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A MEDICAL PROFESSIONAL. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, THE COMPLAINT IS NOT PRODUCT RELATED. 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.

    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. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. IT SHOULD BE NOTED THESE RECORDS WERE RECEIVED THROUGH A PFS. THIS COMPLAINT IS NOT YET LEGAL. PFS ALLEGES PAIN, DISFIGUREMENT, AND DECREASED RANGE OF MOTION. AFTER REVIEW OF THE MEDICAL RECORDS THERE WAS NO MENTION OF METALLOSIS. IT DID INDICATE THE CUP HAD SOME SLIGHT RETROVERSION SO IT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367831 ARTICULEZE M HEAD 36MM +1.5 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2780681

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention