BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE M/B PAT POR STD+

    MDR report key: 3161395 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-18572
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 11, 2013
    Manufacturer
    9616671 DEPUY IRELAND
    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

    LCS DUOFIX REVISION. 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
    262779 LCS COMPLETE M/B PAT POR STD+ PATELLA NJL 9616671 DEPUY IRELAND 2076720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention