BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM CEM L LG

    MDR report key: 2782083 · Received October 11, 2012

    Report

    Report Number
    1818910-2012-20326
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    NJL
    PMA / PMN Number
    P830055/S073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PRODUCT INFORMATION REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE DATABASE BY LOT WAS NOT PROVIDED. PER THE INITIAL REPORTING, PATIENT X-RAYS ARE NOT AVAILABLE FOR EXAMINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE PROVIDED INFORMATION. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN. (LEFT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE FEM CEM L LG FEMORAL KNEE PROSTHESIS NJL DEPUY WARSAW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention