BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT STD+ 10MM

    MDR report key: 2252886 · Received September 19, 2011

    Report

    Report Number
    1818910-2011-18453
    Event Type
    Injury
    Date Received
    September 19, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 4, 2011
    Manufacturer
    DEPUY WARSAW
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIVE AND PREVENTATIVE ACTIONS ARE BEING MANAGED VIA (B)(4) AND (B)(4). THERE WAS NO INDICATION OF DEVIATIONS OR ANOMALIES WITH REGARD TO MATERIAL SPECIFICATION OR INSPECTION SO NO REVIEW OF THE DHR WILL BE CARRIED OUT AT THIS POINT IN TIME. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND / OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME?OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    REQUIRED REVISION DUE TO PAIN SUBSEQUENT TO PRIMARY TOTAL KNEE REPLACEMENT WITH LCS DUOFIX COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMP RP INSERT STD+ 10MM KNEE NJL DEPUY WARSAW BF8HE4

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention