BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS FEM 65MM STD LT

    MDR report key: 4162136 · Received October 10, 2014

    Report

    Report Number
    1818910-2014-29774
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(6).

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EVALUATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A. PATIENT X-RAYS WERE RECEIVED. THE X-RAY REVIEW DID NOT DRAW ANY CONCLUSIONS ABOUT FEMORAL COMPONENT AND TIBIAL TRAY CONTRIBUTION TO THE REPORTED PATIENT PAIN. AT THIS POINT BASED ON THE INFORMATION PROVIDED A ROOT CAUSE CANNOT BE DETERMINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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.

    Description of Event or Problem · 1

    KNEE REVISION PERFORMED ON (B)(6) 2014 AT (B)(6) HOSPITAL. PRIMARY LCS TKJR DONE IN 1994, METAL BACKED PATELLA REVISED IN 2007. FULL REVISION OF THE ENTIRE TKJR WAS PERFORMED FOR PAIN, EFFUSION AND POLY INSERT WEAR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644133 LCS FEM 65MM STD LT KNEE FEMORAL COMPONENT NJL DEPUY ORTHOPAEDICS, INC. 1818910 OCMC03000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention