BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM POR L STD+

    MDR report key: 3881989 · Received June 18, 2014

    Report

    Report Number
    1818910-2014-21440
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 29, 2014
    Report Date
    September 16, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.-1818910
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT STATES THAT A LEFT KNEE REVISION WAS PERFORMED ON A BILATERAL PATIENT. THE DOI WAS (B)(6) 2011 AND DOR WAS (B)(6) 2014. REASON FOR REVISION WAS DUE TO SYNOVITIS AND PAIN. NO MEDICAL RECORDS OR RETURN OF PARTS WERE RETURNED TO CONFIRM THIS. NOTIFICATION WAS RECEIVED STATING THAT NO FURTHER INFORMATION IS AVAILABLE. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE CONDUCTED AS NO LOT NUMBERS WERE RECEIVED. A COMPLAINTS DATABASE SEARCH COULD ONLY BE CONDUCTED ON PRODUCT NUMBER 129404050 WHICH DID NOT IDENTIFY ANY ANOMALIES. A COMPLAINTS SEARCH COULD NOT BE CONDUCTED ON THE OTHER PRODUCTS AS NO PRODUCT NUMBERS WERE RECEIVED. 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. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. NO FURTHER ACTIONS ARE IDENTIFIED. POST MARKET SURVEILLANCE IS PER (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INVESTIGATION HAS BEEN REOPENED BECAUSE THE LOT NUMBER HAS BEEN RECEIVED. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    ***ADDENDUM ADDED 18 AUG 2015 *** THE COMPLAINT WAS REOPENED DUE TO PRODUCT DETAILS WERE RECEIVED. A REVIEW OF THE COMPLAINT DATABASES AND MANUFACTURING RECORDS DID NOT IDENTIFY ANY ANOMALIES. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION AND ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    Description of Event or Problem · 1

    PROCEDURE: LEFT KNEE REVISION OF BILATERAL PATIENT. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2011 BY DR (B)(6) AT (B)(6). PATIENT'S LEFT KNEE WAS REVISED ON (B)(6) 2014 BY DR (B)(6) AT (B)(6). REASON FOR REVISION: SYNOVITIS AND PAIN. SURGEON DID NOT MAKE ANY COMMENTS TO INDICATE THAT REASON FOR REVISION WAS DUE TO FAULT OR FAILURE OF OUR PROSTHESIS. (B)(4) 2014 - ADDED PRODUCT CODES AND LOT NUMBERS NOT CLEAR WHICH PRODUCTS ARE FOR LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359259 LCS COMPLETE FEM POR L STD+ KNEE FEMORAL COMPONENT NJL DEPUY ORTHOPAEDICS, INC.-1818910 3210072

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention