BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PROXIMAL FEMUR JTS REPLACEMENT IMPLANT

    MDR report key: 4870786 · Received June 25, 2015

    Report

    Report Number
    3004105610-2015-00057
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    May 26, 2015
    Report Date
    May 26, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING HISTORY RECORDS OF THE IMPLANT AND THE ALIGNMENT TOOL HAVE BEEN REVIEWED AND CONFIRMED THAT THE DEVICES WERE MANUFACTURED TO SPECIFICATION WITH NO ABNORMALITIES OR DEVIATIONS. A REVIEW OF THE PREVIOUS 24 MONTHS OF COMPLAINTS HISTORY IDENTIFIES NO SIMILAR REPORTED COMPLAINTS. THE ALIGNMENT TOOL HAS BEEN RETURNED FOR EVALUATION. AN INITIAL VISUAL INSPECTION IDENTIFIES THAT THE TOOL CONTAINS DAMAGE AT THE SQUARE END AND ALONG THE SIDES, WHICH LIKELY OCCURRED DURING INSERTION WHEN THE SURGEON HIT THE TOOL WITH A HAMMER. ALSO, THE SQUARE PEG END OF THE TOOL APPEARS TO BE SLIGHTLY "TWISTED." HOWEVER, A POSSIBLE SCENARIO FOR THE SQUARE END OF THE TOOL BEING "TWISTED" IS THAT AFTER HAMMERING THE ALIGNMENT TOOL INTO THE HOLE IN THE GEARBOX, THE TOOL MAY HAVE BECOME WEDGED AND WHILST REMOVING IT, THE SURGEON "TWISTED" THE TOOL. COMPLETION OF THE EVALUATION OF THE TOOL IS PENDING RECEIPT OF ADDITIONAL INFORMATION FROM THE SURGEON. THE INVESTIGATION IS ONGOING; ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE PROVIDED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO JTS EXTENDIBLE IMPLANT (K092138).

    Additional Manufacturer Narrative · 1

    STANMORE IMPLANTS HAS COMPLETED ITS INVESTIGATION OF THE REPORTED COMPLAINT. AT THE TIME THIS ALIGNMENT TOOL WAS RELEASED, THE DOCUMENTATION WAS NOT PRECISE ENOUGH TO VERIFY/CONFIRM EVERY DIMENSIONAL REQUIREMENT TO EVALUATE THE RETURNED PRODUCT. SUBSEQUENT TO THE MANUFACTURE OF THE TOOL, BUT PRIOR TO THE RECEIPT OF THIS COMPLAINT, THE DRAWING WAS UPDATED AS PART OF A LARGER DRAWING REVIEW PROGRAM, TO REFLECT CRITICAL DIMENSIONS. IT HAS SINCE BEEN RE-REVIEWED ((B)(4) 2015) AND FURTHER UPDATED TO ASSURE COMPLETENESS AND COMPATIBILITY. THE SURGEON ALSO EXPRESSED A PREFERENCE THAT A HANDLE BE ADDED TO THE ALIGNMENT TOOL, INSTEAD OF USING A WRENCH TO TURN THE TOOL. THIS IS NOT AN INDICATION OF A FAILURE OF THE ALIGNMENT TOOL TO MEET ITS SPECIFICATIONS. THIS INFORMATION HAS BEEN PASSED TO THE CUSTOM DESIGN GROUP TO BE CONSIDERED IN PRODUCT AND SERVICE IMPROVEMENT ACTIVITIES.

    Description of Event or Problem · 1

    THIS SURGEON PREVIOUSLY REPORTED THAT THE NON-INVASIVE GROWER MOTOR IN THE PATIENT'S CUSTOM PROXIMAL FEMUR JTS REPLACEMENT IMPLANT HAD FAILED (REPORTED UNDER MDR REF #3004105610-2105-00043), AND HE THEREFORE REQUIRED A CUSTOM ALIGNMENT TOOL TO RE-ALIGN THE CUSTOM PROXIMAL FEMUR IMPLANT. DURING THE (B)(6) 2015 ALIGNMENT PROCEDURE, THE SURGEON REPORTED THAT THE ALIGNMENT TOOL DID NOT FIT INTO THE ASSOCIATED HOLE IN THE GEARBOX. AS A RESULT. THE SURGEON INSERTED THE ALIGNMENT TOOL BY HITTING THE TOOL WITH A HAMMER. THIS PROCESS CAUSED A SLIGHT DELAY TO THE PROCEDURE OF 10-15 MINUTES. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY, WITH NO REPORTED PATIENT CONSEQUENCES. THE SURGEON ALSO EXPRESSED A PREFERENCE THAT A HANDLE BE ADDED TO THE ALIGNMENT TOOL, INSTEAD OF USING A WRENCH TO TURN THE TOOL.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL TO MDR 3004105610-2015-00057. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413173 CUSTOM PROXIMAL FEMUR JTS REPLACEMENT IMPLANT LIMB SPARING SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD. BME 19409 BME 19409

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other