BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM POR L LG

    MDR report key: 2527000 · Received April 11, 2012

    Report

    Report Number
    1818910-2012-09639
    Event Type
    Injury
    Date Received
    April 11, 2012
    Date of Event
    March 14, 2012
    Report Date
    March 14, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    NJL
    PMA / PMN Number
    P830055/S105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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

    EXAMINATION OF THE RETURNED DEVICES REVEALED EVIDENCE INDICATING DEVICE LOOSENING OF THE TIBIAL COMPONENT IN VIVO. IT SHOULD BE NOTED THAT EXAMINATION DID FIND MINIMAL BONY INGROWTH ON BOTH TIBIAL AND FEMORAL COMPONENTS. A SEARCH OF THE COMPLAINT DATABASES DID NOT SHOW ANY OTHER REPORTS AGAINST THE MANUFACTURING LOT CODES SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE DEVICE LOOSENING; HOWEVER, EVIDENCE WAS FOUND SUGGESTING POOR FIXATION WAS A LIKELY CONTRIBUTING FACTOR. NO EVIDENCE WAS FOUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    REVISED DUE TO ASEPTIC LOOSENING AND NO BONY INGROWTH ON THE IMPLANTS. PATIENT COMPLAINED OF PAIN AND THERE WAS SWELLING IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE FEM POR L LG KNEE NJL DEPUY WARSAW 2715826

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention