BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM CEM R STD+

    MDR report key: 2896490 · Received January 4, 2013

    Report

    Report Number
    1818910-2013-10243
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    DEPUY (IRELAND)
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. ADDITIONAL INFORMATION RELEVANT TO THE EVENT WAS REQUESTED BUT NOT PROVIDED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT KNEE REVISION SURGERY FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5098 LCS COMPLETE FEM CEM R STD+ FEMORAL COMPONENT NJL DEPUY (IRELAND) 3336721

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention