BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM POR L STD

    MDR report key: 3843230 · Received June 2, 2014

    Report

    Report Number
    1818910-2014-19885
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 14, 2014
    Report Date
    January 14, 2016
    Manufacturer
    DEPUY IRELAND REG. # 9616671
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REMAINS CLOSED, AS THIS CORRECTED INFORMATION DOES NOT HAVE ANY IMPACT ON THE OUTCOME OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. PER REQUEST BY CUSTOMER, A DHR REVIEW WAS CONDUCTED ON THE PROVIDED PRODUCT/LOT COMBINATION. THE INITIAL REPORTING STATED NO ADDITIONAL INVESTIGATIONAL INPUTS WERE AVAILABLE. 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.

    Description of Event or Problem · 1

    PROCEDURE: KNEE REVISION. ORIGINALLY IMPLANTED IN (B)(6) 2012. REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 BY THE SAME SURGEON. REASON FOR REVISION WAS DUE TO ONGOING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321646 LCS COMPLETE FEM POR L STD KNEE FEMORAL COMPONENT NJL DEPUY IRELAND REG. # 9616671 3514250

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention