BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCS COMPLETE FEM CEM L LG

    MDR report key: 7902404 · Received September 24, 2018

    Report

    Report Number
    1818910-2018-70209
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Report Date
    August 31, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295021643
    PMA / PMN Number
    P830055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO PRODUCT WAS RETURNED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. 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

    THE 'LIFT HERE' STERILE TABS ON THE PACKAGING TORE OFF (TIBIAL TRAY) AND STARTED TO TEAR AWAY (FEMORAL COMPONENT) (AS LISTED ABOVE) WHEN LIFTING THE IMPLANTS FROM THE NON-STERILE PACKAGING WITH ARTERY FORCEPS WITH THE 'LIFT HERE' TAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745349 LCS COMPLETE FEM CEM L LG LCS COMPLETE : KNEE FEMORAL NJL DEPUY ORTHOPAEDICS INC US 8588160 10603295021643

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR