BEUDAMED
    FDA Adverse Event Summary report: N

    CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT

    MDR report key: 6002997 · Received October 6, 2016

    Report

    Report Number
    3004105610-2016-00028
    Date Received
    October 6, 2016
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REVISED WITH A NEW PROSTHESIS WITH NO ADVERSE CONSEQUENCES REPORTED. THE NEW DEVICE HAS SINCE HAD A SUCCESSFUL LENGTHENING PROCEDURE. THE DEVICE HAS BEEN RETURNED TO SIW AND WILL BE INSPECTED AS PART OF THE INVESTIGATION OF THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REVISED WITH A NEW PROSTHESIS WITH NO ADVERSE CONSEQUENCES REPORTED. THE NEW DEVICE HAS SINCE HAD A SUCCESSFUL LENGTHENING PROCEDURE. THE DEVICE HAS BEEN RETURNED TO SIW AND WILL BE INSPECTED AS PART OF THE INVESTIGATION OF THIS COMPLAINT. UPDATE 03 JULY 2017 - UPDATED WITH THE EVENT DESCRIPTION AS PER EMAIL REQUEST FROM (B)(4) DATED 29 JUNE 2017.

    Additional Manufacturer Narrative · 1

    THE GROWER UNIT WAS PRODUCED TO SPECIFICATION AND PASSED ALL MANUFACTURING PRE-RELEASE TESTS. AFTER A REBUILD AND TEST EXERCISE, NO EVIDENCE WAS FOUND TO SUGGEST THE DEVICE WOULD NOT PERFORM AS DESIGNED. THE LEAD SCREW/SHAFT SLIDING SURFACES APPEAR TO HAVE SEIZED IN USE, THE STATEMENT MADE IN THE INITIAL COMPLAINT WAS THAT THE GROWER MECHANISM "FELT STICKY FROM THE START" WOULD INDICATE THAT THE DEVICE WAS NOT WORKING AS EXPECTED FROM THE INITIAL IMPLANT DATE. DURING SUBSEQUENT EVALUATIONS OF THE DEVICE, IT HAS NOT BEEN POSSIBLE TO REPLICATE THE REPORTED FAILURE MODE. THE JTS GEARBOX ASSEMBLY WAS DISASSEMBLED/RE-ASSEMBLED AND WORKED AS INTENDED. EVALUATION CONDUCTED BY THE BUILD TECHNICIAN CONFIRMED THE DEVICE WORKED WITHOUT FAULT AND THAT THE SOUND OF THE GEARBOX MECHANISM WHILE IT WAS RUNNING WAS AS EXPECTED. 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.

    Description of Event or Problem · 1

    REF SIW: (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOM JTS DISTAL FEMUR IMPLANT CANNOT BE LENGTHENED. THIS IS THE FIRST SUPPLEMENTAL REPORT TO 3004105610-2016-00028 (SIW-16-1417).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOM JTS DISTAL FEMUR IMPLANT CANNOT BE LENGTHENED. THIS IS THE SECOND SUPPLEMENTAL REPORT TO 3004105610-2016-00028 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661571 CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT LIMB SALVAGE SYSTEM, KRO STANMORE IMPLANTS WORLDWIDE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1