BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-STEM SIZE 7 PRIMARY

    MDR report key: 6034171 · Received October 17, 2016

    Report

    Report Number
    1818910-2016-29471
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    August 9, 2012
    Report Date
    January 8, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K982918
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. UNFORTUNATELY NO SAMPLES OF LOT NUMBERS 2280230 SMARTSET GHV AND 2221997 SMARTSET GHV REMAIN IN THE CONTROL OF DEPUY CMW AND AS SUCH NO INVESTIGATIVE TESTING CAN BE CONDUCTED. A SEARCH OF THE COMPLAINT DATABASE FOUND COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE - BY LOT NUMBER - 0/0/0. BY PRODUCT CODE - 0/0/0. BY PRODUCT FAMILY - 25 (6XGMV EO, 1X GMV ENDURANCE, 4X GHV, 7X MV EO, 3X MV ENDURANCE, 4X HV). THE DEVICE HISTORIES WERE REVIEWED: 2280230: DEVICE HISTORY REVIEWED: 1 UNRELATED NON CONFORMANCE(S) ON THIS BATCH. FINAL MICRO AND STERILITY TESTS PASSED; 2221997: DEVICE HISTORY REVIEWED: 2 UNRELATED NON CONFORMANCE(S) ON THIS BATCH. FINAL MICRO AND STERILITY TESTS PASSED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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.

    Description of Event or Problem · 1

    CLINICAL STUDY (B)(4). SUBJECT WAS REVIEWED ON (B)(6) AND WAS IDENTIFIED TO HAVE A LOOSE FEMORAL COMPONENT ON THE LEFT SIDE. SUBJECT HAS BEEN SCHEDULED FOR A REVISION PROCEDURE IN (B)(6) 2013 TO REMOVE THE LOOSE FEMORAL COMPONENT. IT IS CURRENTLY UNKNOWN WHICH OTHER COMPONENTS WILL BE REMOVED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685766 C-STEM SIZE 7 PRIMARY HIP FEMORAL STEM/SLEEVE JDI DEPUY ORTHOPAEDICS, INC. 2178016

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention