BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT

    MDR report key: 4265310 · Received November 4, 2014

    Report

    Report Number
    3004105610-2014-00041
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELAY IN DISPATCH OF THE CUSTOM DEVICE WAS DUE TO A TEMPORARY STAFFING ISSUE WHICH CAUSED A DELAY IN CREATING A FINAL DESIGN OF THE CUSTOM DEVICE. ALTHOUGH THE SURGERY WAS DELAYED FOUR DAYS, THE SURGERY WAS SUCCESSFUL AND THE PATIENT IS REPORTED TO BE WELL FOLLOWING THE SURGERY. NOTE: THIS CUSTOM DEVICE IS SIMILAR TO JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152).

    Additional Manufacturer Narrative · 1

    A DISTAL FEMUR JTS WAS SUCCESSFULLY IMPLANTED WITH NO REPORTED COMPLICATIONS. THE CAUSE OF THE LATE SHIPMENT WAS ATTRIBUTED TO A TEMPORARY STAFFING ISSUE WHICH CAUSED A DELAY IN CREATING A FINAL DESIGN OF THE CUSTOM DEVICE. ALTHOUGH THE SURGERY WAS DELAYED 4 DAYS, THE SURGERY WAS SUCCESSFUL AND THE PATIENT IS REPORTED TO BE DOING WELL FOLLOWING SURGERY. AS A RESULT, STANMORE IS NOW COMMITTING TO MANUFACTURING AND RELEASE DATES FOR CUSTOM IMPLANTS ONLY AFTER THE DESIGN REQUIREMENTS ARE FULLY UNDERSTOOD AND DOCUMENTED. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. SIW WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTED DATA: COMMON DEVICE NAME/PRODUCT CODE WAS CORRECTED FROM "CUSTOM DISTAL FEMUR IMPLANT" TO "LIMB SALVAGE SYSTEM/KRO". EXPIRATION DATE WAS CORRECTED FROM 04/08/2015 TO 04/09/2015.

    Description of Event or Problem · 1

    THE PATIENT WAS DIAGNOSED WITH OSTEOSARCOMA OF THE RIGHT LEG IN 2011. A STANMORE IMPLANT WAS PROVIDED AS A PART OF TREATMENT OF THE DISEASE IN (B)(6) 2011. THE IMPLANT BECAME LOOSE AND THE SURGEON REQUESTED TO REVISE IN (B)(6) 2014, THIS WAS REPORTED UNDER MFR REPORT # 3004105610-2014-00025. IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE SURGICAL PROCEDURE DATE HAS CHANGED FROM (B)(6) 2014. THIS FOUR DAY DELAY WAS DUE TO THE NOTIFICATION OF LATE DISPATCH OF THE CUSTOM IMPLANT BY STANMORE IMPLANTS WORLDWIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE SURGICAL PROCEDURE DATE HAS CHANGED FROM (B)(6) 2014. THIS FOUR DAY DELAY WAS DUE TO THE NOTIFICATION OF LATE DISPATCH OF THE CUSTOM IMPLANT BY STANMORE IMPLANTS WORLDWIDE. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00041 ((B)(4)). NOTE: COMPLAINT (B)(4) HAS BEEN SPLIT INTO TWO PARTS - (B)(4) (3004105610-2014-00025) REGARDING ASEPTIC LOOSENING AND (B)(4) (3004105610-2014-00041) REGARDING CUSTOMER SERVICE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706252 CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME18939

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization