BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM CEM R LG

    MDR report key: 1040453 · Received May 8, 2008

    Report

    Report Number
    1818910-2008-01404
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 9, 2008
    Manufacturer
    DEPUY - CORK
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE AS NO PROD WAS RETURNED. A SEARCH OF THE WARSAW AND INTL COMPLAINT DATABASE DID NOT FIND ANY ADD'L REPORTS OF THIS NATURE FOR THE PROD CODE/LOTS PROVIDED SINCE THEIR RESPECTIVE RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DETERMINE THE ROOT CAUSE OF THE LOOSENING FOUND. NO EVIDENCE WAS FOUND THAT WOULD SUGGEST PROD ERROR WAS A CONTRIBUTING FACTOR. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PROD AND/OR ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED DUE TO PAIN AND SWELLING ATTRIBUTED TO LOOSENING OF THE FEMORAL COMPONENT AND PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE FEM CEM R LG 87NJL NJL DEPUY - CORK NA 2150587

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention