BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT STD 12.5MM

    MDR report key: 3011393 · Received March 19, 2013

    Report

    Report Number
    1818910-2013-14100
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 4, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    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

    VISUAL EXAMINATION OF THE RETURNED BILATERAL DEVICES FINDS THE TIBIAL INSERTS DISPLAY EXCESSIVE PITTING AND SCRATCHES ON BOTH THE ARTICULATING AND NON-ARTICULATING SURFACES. MATCHING WEAR IS FOUND ON BOTH FEMORAL AND TIBIAL COMPONENT ARTICULATING SURFACES INDICATING THE PRESENCE OF THIRD BODY PARTICULATES, MOST LIKELY DUE TO BONE CEMENT. IT WAS NOT INDICATED IF OR IF NOT THE PATIENT HAD A TRAUMA PRIOR TO REVISION. REVIEW OF PROVIDED PATIENT X-RAYS FINDS THE FEMORAL COMPONENTS HAVE SLIGHT GAP ON THE ANTERIOR FLANGES. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. 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. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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

    REVISION WAS DONE ON BOTH KNEES. DURING THE SURGERY, IT WAS NOTED THAT SYNOVIALIS WAS BLACKENED AND METALLOSIS EXISTED IN BOTH KNEES.

    Description of Event or Problem · 1

    UPDATE (B)(4) 2013 LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114178 LCS COMP RP INSERT STD 12.5MM TIBIAL INSERT NJL DEPUY ORTHOPAEDICS ER9HI4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention