BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT STD+ 10MM

    MDR report key: 3161392 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-18567
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 11, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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.

    Description of Event or Problem · 1

    REASON FOR REVISION: PAIN. (B)(6) 2013 - UPDATED - PRODUCT DETAILS RECEIVED FOR TIBIAL TRAY, INSERT AND PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262778 LCS COMP RP INSERT STD+ 10MM TIBIAL INSERT NJL DEPUY ORTHOPAEDICS AX3F34000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention