BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM POR R STD+

    MDR report key: 3881732 · Received June 18, 2014

    Report

    Report Number
    1818910-2014-21434
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 29, 2014
    Report Date
    July 13, 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 REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT STATES A RIGHT KNEE REVISION OF BILATERAL PATIENT WAS PERFORMED. THE DOI: (B)(6) 2011. DOR: (B)(6) 2014. REASON FOR REVISION WAS DUE SYNOVITIS AND PAIN. SURGEON DID NOT MAKE ANY COMMENTS TO INDICATE THAT REASON FOR REVISION WAS DUE TO FAULT OR FAILURE OF OUR PROSTHESIS. NO MEDICAL RECORDS WERE RECEIVED TO CONFIRM THIS. A DHR OF LOT 3257106 DID NOT IDENTIFY ANY ANOMALIES. A DHR COULD NOT BE CONDUCTED OF THE OTHER PRODUCTS AS NO LOT NUMBERS WERE PROVIDED. COMPLAINTS DATABASES SEARCHED ON PRODUCT CODES 129403050 IDENTIFIED SIMILAR COMPLAINTS RECEIVED PREVIOUSLY. A COMPLAINT DATABASE 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). **ADDENDUM ADDED 06 AUG 2015** A COMPLAINTS SEARCH IDENTIFIED PREVIOUS COMPLAINTS FOR PAIN UNDER THE PRODUCT CODES PROVIDED HOWEVER A LOT SPECIFIC SEARCH DID NOT IDENTIFY ANY PREVIOUS COMPLAINTS. THE ABOVE CONCLUSION REMAINS VALID.

    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.

    Description of Event or Problem · 1

    PROCEDURE: RIGHT KNEE REVISION OF BILATERAL PATIENT. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2011. PATIENT'S RIGHT KNEE WAS REVISED ON (B)(6) 2014. 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)(6) 2014 - ADDED PRODUCT CODES AND LOT NUMBERS NOT CLEAR WHICH PRODUCTS ARE FOR RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357048 LCS COMPLETE FEM POR R STD+ KNEE FEMORAL COMPONENT NJL DEPUY ORTHOPAEDICS, INC.-1818910 3257106

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention