BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS FEMORAL COMPONENT

    MDR report key: 2850075 · Received November 29, 2012

    Report

    Report Number
    1818910-2012-28393
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    JWH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 PATIENT UNDERWENT TKR REVISION FOR AN LCS RIGHT KNEE PROSTHESIS. THE FEMORAL COMPONENT AND POLY-ETHYLENE BEARING WERE REMOVED AND REVISED. THE MBT TIBIAL COMPONENT REMAINS IN SITU. THE REASON FOR REVISION WAS LOOSENING OF THE FEMORAL COMPONENT AND PRESENCE OF AN ECTOPIC BONE MASS ON THE POSTERIOR ASPECT OF THE KNEE. THE PATIENT IS BOOKED FOR RADIOLOGY TREATMENT OF THE BONE MASS ON THE (B)(6) 2012. THE PATIENT'S RIGHT KNEE WAS REVISED PREVIOUSLY IN 2009 BY DR (B)(6), WHO HAD ALSO PERFORMED THE PRIMARY KNEE IMPLANT PROCEDURE. (AT (B)(6) HOSPITAL) THERE ARE NO X-RAYS, NO PRODUCT CODES, AND NO ADDITIONAL INFORMATION AVAILABLE EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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.

    Description of Event or Problem · 1

    THE REASON FOR REVISION WAS LOOSENING OF THE FEMORAL COMPONENT AND PRESENCE OF AN ECTOPIC BONE MASS ON THE POSTERIOR ASPECT OF THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS FEMORAL COMPONENT DEPUY KNEE IMPLANT JWH DEPUY WARSAW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention