BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCS COMPLETE REV FEM CEM R STD

    MDR report key: 2090737 · Received April 28, 2011

    Report

    Report Number
    1818910-2011-05954
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 30, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S090
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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

    THE DEVISE NOR PACKAGING LABEL ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE DATABASES DID NOT SHOW ANY OTHER REPORTS WITH REGARDS TO THE REPORTED EVENT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT: HOWEVER, IT WAS DISCOVERED THE VVC NOTATION IS USED ON THE INSERT COMPONENTS ONLY, NOT THE FEMORAL COMPONENTS. THE FEMORAL COMPONENTS ARE NOTED BY REV. THE PRICE LIST MENTIONED IN THE COMPLAINT DESCRIPTION WAS NOT RETURNED; THEREFORE NOT COMMENTS COULD BE MADE REFERENCING IT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND / OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THIS IS A LABELLING ISSUE. DURING REVISION KNEE SURGERY, THE WRONG FEMORAL COMPONENT WAS OPENED DUE TO A LABELLING ISSUE, AND NEARLY IMPLANTED. SURGERY TIME WAS EXTENDED DUE TO THE ERROR, AND THE HOSPITAL INCURRED EXTRA COST AS THEY WERE REQUIRED TO OPEN THE APPROPRIATE FEMUR AND EXTRA FEMORAL AUGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE REV FEM CEM R STD 87 NJL NJL DEPUY ORTHOPAEDICS, INC. NA C74J1000

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention