BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM POR L LG

    MDR report key: 2447408 · Received February 13, 2012

    Report

    Report Number
    1818910-2012-03503
    Event Type
    Injury
    Date Received
    February 13, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 24, 2012
    Manufacturer
    DEPUY IRELAND
    Product Code
    NJL
    PMA / PMN Number
    P830055/S105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE 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 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

    THE PATIENT HAD PRESENTED IN 2011 WITH PAIN AND SWELLING. THE PATIENT HAD AN LCS KNEE, UNDERWENT LAPAROSCOPIC KNEE EVALUATION AND THE SURGEON NOTICED SCRATCHING OF THE FEMUR AND SOME LOOSE BEADS IN THE JOINT SPACE. ON (B)(6) 2012, THE IMPLANT WAS REVISED DUE TO THE DAMAGE AND THE ONGOING ISSUES WITH SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE FEM POR L LG KNEE NJL DEPUY IRELAND 2976255

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention