BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL FEMUR JTS

    MDR report key: 5808104 · Received July 20, 2016

    Report

    Report Number
    3004105610-2016-00054
    Event Type
    Injury
    Date Received
    July 20, 2016
    Date of Event
    June 21, 2016
    Report Date
    June 21, 2016
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FAILURE OF THE DISTAL FEMUR JTS IMPLANT IS ALLEGED BY THE SURGEON. DUE TO METASTATIC DISEASE, THE IN SITU DISTAL FEMUR JTS IMPLANT WILL BE REVISED TO ALLOW FOR CONNECTION TO THE NEW PROXIMAL TIBIA IMPLANT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER THE OPERATION IS PERFORMED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMAGING SUPPLIED BY THE HOSPITAL CONCLUDED THAT THERE WAS NO VISIBLE DEFECT OR ISSUE WITH THE IN SITU DISTAL FEMUR JTS. BASED ON THE INFORMATION PROVIDED A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. FURTHER INFORMATION SUCH AS PRODUCT RETURN, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. THE COMPLAINT IS BEING CLOSED AND TRACKED AND TRENDED.

    Description of Event or Problem · 1

    (B)(4). THE PATIENT HAS A HISTORY OF OSTEOSARCOMA AND UNDERWENT A DISTAL FEMUR JTS IMPLANT ON (B)(6) 2015. THE PATIENT IS NOW REPORTED TO HAVE PRESENTED WITH METASTATIC DISEASE OF THE PROXIMAL TIBIA. AS A RESULT OF DISEASE PROGRESSION, A PROXIMAL TIBIAL IMPLANT HAS BEEN ORDERED. THE IN SITU DISTAL FEMUR JTS IMPLANT WILL BE REVISED TO ALLOW FOR THE CONNECTION OF THE PROXIMAL TIBIAL IMPLANT. SCHEDULING OF THE OPERATION DATE IS PENDING.

    Description of Event or Problem · 1

    THE PATIENT HAS A HISTORY OF OSTEOSARCOMA AND UNDERWENT A DISTAL FEMUR JTS IMPLANT ON (B)(6) 2015. THE PATIENT IS NOW REPORTED TO HAVE PRESENTED WITH METASTATIC DISEASE OF THE PROXIMAL TIBIA. AS A RESULT OF DISEASE PROGRESSION, A PROXIMAL TIBIAL IMPLANT HAS BEEN ORDERED. THE IN SITU DISTAL FEMUR JTS IMPLANT WILL BE REVISED TO ALLOW FOR THE CONNECTION OF THE PROXIMAL TIBIAL IMPLANT. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2016-00054 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463103 DISTAL FEMUR JTS LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 19398 PIN 19398

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other