BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE REV FEM CEM R MED

    MDR report key: 3062659 · Received April 17, 2013

    Report

    Report Number
    1818910-2013-15452
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 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

    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 REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915. NO ADDITIONAL INFORMATION WAS OBTAINED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER RELATED OR SIMILAR REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF PROVIDED PATIENT X-RAYS FINDS THE M/L VIEW SHOWS DECREASED RADIOGRAPHIC DENSITY BEHIND THE ANTERIOR FLANGE OF THE FEMORAL COMPONENT AS COMPARED TO THE SURROUNDING SUBSTRATE. THE A/P X-RAY SHOWS DECREASED RADIOGRAPHIC DENSITY ON THE LATERAL SIDE FOR BOTH FEMORAL AND TIBIAL COMPONENT DIRECTLY PROXIMAL AND DISTAL RESPECTIVELY AS COMPARED TO THE SURROUNDING SUBSTRATE. 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 THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED PAINFUL KNEE FOR SOMETIME. X-RAYS INDICATED THAT ONE OR MORE COMPONENT MAY BE LOOSE AND A DECISION WAS MADE TO OPEN THE PATIENT TO EVALUATE COMPONENT FIXATION. ON OPENING KNEE, IT WAS NOTED THAT FEMORAL COMPONENT WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165052 LCS COMPLETE REV FEM CEM R MED FEMORAL COMPONENT NJL DEPUY ORTHOPAEDICS CW8FP1000

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention