BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS TEX FEM STD LT

    MDR report key: 2663561 · Received July 20, 2012

    Report

    Report Number
    1818910-2012-16749
    Event Type
    Injury
    Date Received
    July 20, 2012
    Date of Event
    July 17, 2012
    Report Date
    July 17, 2012
    Manufacturer
    DEPUY IRELAND
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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: FOLLOWING INVESTIGATION BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: ROOT CAUSE: UNDETERMINED, FROM THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO SAY WHY THIS TOTAL KNEE REPLACEMENT FAILED. FROM THE COMPLAINANTS REPORT IT WOULD APPEAR THAT SOME BONE CEMENT CAUSED DAMAGE TO THE FEMORAL COMPONENT LEADING TO METALLOSIS. IT WAS NOT POSSIBLE TO CONFIRM THIS. ETQ COMPLAINTS DATABASE SEARCHED ON PRODUCT LOT 1000405, 1013459 1009201 IDENTIFIED NO SIMILAR COMPLAINTS RECEIVED PREVIOUSLY. SIZE OF IMPLANT IS REASONABLE. TRAY IS AT 90DEG TO LONG AXIS OF TIBIA. IT IS NOT POSSIBLE TO CHECK THE FEMORAL POSITION. PER THE COMPLAINT REPORT NO LUCENCY VISIBLE ON EITHER X-RAY. REVIEW OF MANUFACTURING RECORDS FOR PRODUCT LOT 1000405, 1013459 1009201 WAS COMPLETED BY THE MANUFACTURING SITE ((B)(4)), WITH NOTIFICATION RECEIVED THAT: ALL ATTACHED REVIEWED AND NO ISSUES. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    Description of Event or Problem · 1

    FURTHER SURGERY PERFORMED CONSEQUENT TO PATIENT REPORTING PAIN OVER PRECEDING 2 MONTHS. NO SIGNS OF LUCENCY WERE EVIDENT ON X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS TEX FEM STD LT DEPUY KNEE IMPLANT NJL DEPUY IRELAND 1000405

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention