BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE REV FEM CEM L LG+

    MDR report key: 3213917 · Received July 9, 2013

    Report

    Report Number
    1818910-2013-20747
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC
    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. TWO X-RAY IMAGES WERE PROVIDED: ONE A/P VIEW AND ONE M/L VIEW. NO DATES ARE PRINTED ON THE IMAGES, SO X-RAY DATES CANNOT BE CONFIRMED. REDUCED RADIOGRAPHIC DENSITY IS APPARENT UNDER LATERAL SIDE OF TIBIAL PLATEAU. . 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 CONCLUSION 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 ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. TWO X-RAY IMAGES WERE PROVIDED: ONE A/P VIEW AND ONE M/L VIEW. NO DATES ARE PRINTED ON THE IMAGES, SO X-RAY DATES CANNOT BE CONFIRMED. REDUCED RADIOGRAPHIC DENSITY IS APPARENT UNDER LATERAL SIDE OF TIBIAL PLATEAU. . 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 CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. LEEDS INVESTIGATION (B)(4) 2013. CONCLUSION AND JUSTIFICATION STATUS: FOLLOWING INVESTIGATION BY DEPUY U.S. AND LEEDS BIOENGINEERING, IT WAS CONCLUDED THAT: IT IS LIKELY IN THIS CASE THAT AN UNKNOWN COMBINATION OF SEVERAL FACTORS OCCURRED ¿ SUCH AS PATIENT FACTORS, SURGICAL PROCEDURE, SURGICAL PROCESS AND IMPLANT DESIGN. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    Description of Event or Problem · 1

    REASON FOR REVISION: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312430 LCS COMPLETE REV FEM CEM L LG+ FEMORAL COMPONENT NJL DEPUY ORTHOPAEDICS INC A4BDN1000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention