BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT REVISION CEM TIB TRAY SZ 3

    MDR report key: 2862122 · Received December 7, 2012

    Report

    Report Number
    1818910-2012-83253
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 20, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    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: FOLLOWING INVESTIGATION BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: ROOT CAUSE: UNDETERMINABLE. THE PERFORMANCE OF DUOFIX FEMORAL RE-REVISION PROCEDURES IS BEING REVIEWED AS PART OF CAPA (B)(4). AN ADVERSE TREND HAS NOT BEEN NOTED HOWEVER, FURTHER INVESTIGATIONS ARE BEING PERFORMED AS PART OF CAPA (B)(4). 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

    REVISION PERFORMED AS TIBIA HAD COLLAPSED ON ONE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBT REVISION CEM TIB TRAY SZ 3 DEPUY KNEE IMPLANT NJL DEPUY ORTHOPAEDICS, INC. DY5ER1000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention