BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS TEX FEM STD+ LT

    MDR report key: 2960769 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-12328
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 4, 2013
    Manufacturer
    DEPUY IRELAND
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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

    CONCLUSION AND JUSTIFICATION STATUS: COMPLAINT INVESTIGATION IDENTIFIED THAT INSUFFICIENT INFORMATION HAD BEEN PROVIDED TO VERIFY THE REPORTED INCIDENT. MANUFACTURING RECORD REVIEW AND A REVIEW OF OUR COMPLAINTS DATABASE IDENTIFIED NO ISSUES REPORTED PREVIOUSLY WITH PRODUCTS FROM THE RESPECTIVE LOTS. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED; THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    REVISION KNEE SURGERY. PATIENT REVISED DUE TO ASEPTIC LOOSENING. PRODUCTS HAVE BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65465 LCS TEX FEM STD+ LT FEMORAL COMPONENT NJL DEPUY IRELAND 1159645

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention