BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS FEM 75MM LG RT

    MDR report key: 5996416 · Received October 4, 2016

    Report

    Report Number
    1818910-2016-28674
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    September 27, 2016
    Report Date
    September 27, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(4). 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

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649226 LCS FEM 75MM LG RT KNEE FEMORAL COMPONENT NJL DEPUY ORTHOPAEDICS, INC. 1818910 VH5CY1001

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention