BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ5

    MDR report key: 3832043 · Received May 27, 2014

    Report

    Report Number
    1818910-2014-19442
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    November 23, 2013
    Report Date
    May 1, 2014
    Manufacturer
    DEPUY IRELAND REG. # 9616671
    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

    A COMPLAINTS DATABASE SEARCH AND REVIEW OF MANUFACTURING RECORDS DID NOT IDENTIFY ANY ANOMALIES. WITHOUT FURTHER INFORMATION OR RETURN OF PRODUCTS THE ROOT CAUSE OF THE COMPLAINT CANNOT BE CONFIRMED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION AND ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. NO FURTHER ACTIONS ARE IDENTIFIED. POST MARKET SURVEILLANCE IS PER SEP 419.

    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

    PROCEDURE: DUOFIX RE-REVISION. 2ND REVISION LEFT TKR. PATIENT HAD LCS DUOFIX COMPONENTS IMPLANTED ON THE LEFT KNEE ON 10 SEPTEMBER 2007 . LEFT KNEE WAS FIRST REVISED ON (B)(6) 2009 AND LCS DUOFIX FEMUR REMOVED. 2ND REVISION LEFT TKR WAS PERFORMED ON (B)(6) 2013. SURGEON REVISED THE COMPONENTS IN SITU ? SIZE 5 MBT CEMENTED KEELED TRAY, 15MM RP INSERT, LARGE MODULAR LCS FEMUR. THE IMPLANTS WERE REVISED FOR LOOSENING AND THESE COMPONENTS WOULD HAVE BEEN DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310530 MBT CEM KEEL TIB TRAY SZ5 KNEE TIBIAL TRAY NJL DEPUY IRELAND REG. # 9616671 2862269

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention