BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS TEX FEM LG LT

    MDR report key: 3123604 · Received May 22, 2013

    Report

    Report Number
    1818910-2013-17462
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    9616671 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

    CONCLUSION AND JUSTIFICATION STATUS: COMPLAINT INVESTIGATION IDENTIFIED THAT INSUFFICIENT INFORMATION HAD BEEN PROVIDED TO VERIFY THE REPORTED INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS AND A SEARCH OF THE COMPLAINTS DATABASE IDENTIFIED NO KNOWN ANOMALIES AND NO KNOWN TRENDS OF THE REPORTED PRODUCTS. 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.

    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.

    Description of Event or Problem · 1

    REVISION OF TOTAL KNEE REPLACEMENT DUE TO CONTINUOUS PAIN SINCE DAY OF IMPLANTATION IN 2005. THE SURGEON FOUND THAT THE PATIENT WAS SUFFERING FROM METAL SENSITIVITY, IT APPEARED THAT THE TIBIAL TRAY HAS BECOME LOOSE DUE TO A LOT OF METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225577 LCS TEX FEM LG LT FEMORAL COMPONENT NJL 9616671 DEPUY IRELAND 1093514

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention