BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE M/B PAT POR LG

    MDR report key: 2903441 · Received January 9, 2013

    Report

    Report Number
    1818910-2013-10615
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    WARSAW ORTHOPAEDICS
    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: FOLLOWING INVESTIGATION BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: ROOT CAUSE: UNDETERMINABLE, IT IS NOT POSSIBLE TO SAY WHAT CAUSED THE DAMAGE NOTED ON THE PARTS OR WHY REVISION WAS REQUIRED. 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. 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

    KNEE REVISION DUE TO PATIENT COMPLAINT OF ANTERIOR KNEE PAIN. SOME MINOR SCRATCHING APPARENT ON SURFACE OF MBT TIBIAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12221 LCS COMPLETE M/B PAT POR LG PATELLA NJL WARSAW ORTHOPAEDICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention