BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS DRIVE UNIT SET

    MDR report key: 14235621 · Received April 28, 2022

    Report

    Report Number
    3004105610-2022-00062
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 7, 2022
    Report Date
    July 26, 2022
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THIS EVENT IS RELATED TO A JTS DRIVE UNIT WHICH IS USED IN CONJUNCTION WITH THE JTS NON-INVASIVE EXTENDIBLE IMPLANT (K092138) SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING NON FUNCTIONALITY INVOLVING A JTS, DRIVE UNIT WAS REPORTED. THE EVENT WAS CONFIRMED BY FUNCTIONAL INSPECTION.METHOD & RESULTS:DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION:VISUAL INSPECTION OF THE JTS COIL REPORTED, SHOWED SMALL SCRATCHES ON THE RIM OF THE COIL AND A SMALL PLASTIC KIDS STICKER COVERING THE DEVICE DESCRIPTION PANEL. ON THE BACK OF THE POWER UNIT, THE PLASTIC COVERING PROTECTING THE BOOST FEATURE IS BROKEN. BOTH THE MAGNETIC COIL AND THE POWER UNIT CONSOLE SHARE THE SAME SERIAL NUMBER ¿907-502¿ AND BOTH DEVICES STATE THE DATE OF MANUFACTURE IS ¿MAY-16¿. FUNCTIONAL INSPECTION:REVIEW OF THE ANNUAL MAINTENANCE AND FUNCTIONAL INSPECTION INDICATES THE DEVICE DID NOT PASS FUNCTIONAL INSPECTION, UNDER THE COMMENTS / OBSERVATION SECTION IT STATES " NO ROTATION ON POLARITY TEST. UNABLE TO TEST FURTHER".CLINICIAN REVIEW:A REVIEW OF THE PROVIDED X-RAYS BY A CLINICAL CONSULTANT INDICATED:THE IMPLANT IN SITU WAS FOR JTS DISTAL FEMORAL REPLACEMENT WHICH WAS INSERTED ON 02JUN2021. THE SURGEON INITIALLY REPORTED FAILURE OF EXTENSION, BUT AFTERWARDS THE IMPLANT WAS SUCCESSFULLY EXTENDED AFTER CHANGING THE DRIVE UNIT. THE THREE IMAGES PROVIDED (ALL TAKEN ON 7TH APRIL 2022) SHOW THE IMPLANT HAD SOME EXTENSION (THE AMOUNT OF EXTENSION CANNOT BE READ CLEARLY), BUT DON¿T KNOW WHETHER THESE IMAGES WERE TAKEN BEFORE OR AFTER FAILURE OF EXTENSION. THERE IS NO IMAGE PROVIDED AFTER 06MAY2022 TO SHOW SUCCESSFUL EXTENSION AFTER CHANGING THE DRIVE UNIT.THEREFORE, DUE TO LACK OF ADEQUATE IMAGES, THE RADIOGRAPHIC REVIEW CANNOT CONFIRM THE CLINICAL REPORT.DEVICE HISTORY REVIEW:REVIEW OF THE ANNUAL MAINTENANCE AND FUNCTIONAL INSPECTION INDICATES THE DEVICE SUCCESSFULLY PASSED FUNCTIONAL INSPECTION. NO COMMENTS/ OBSERVATIONS.COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENT.CONCLUSION:IT WAS REPORTED DRIVE UNIT 907-502 DID NOT PASS THE FUNCTIONAL INSPECTION AND UNDER THE COMMENTS/ OBSERVATION SECTION IT STATES " NO ROTATION ON POLARITY TEST. UNABLE TO TEST FURTHER".AN UPDATE ON 12MAY22 WAS PROVIDED "WE LENGTHENED HIM SUCCESSFULLY ON FRIDAY MAY 6, 2022. THE MAGNET THAT WAS PREVIOUSLY USED WHAT IN FACT THE ISSUE AND IT HAS BEEN SENT IN FOR REPAIR [..] THE PATIENT IS DOING WELL AND WILL COME BACK IN 4 MONTHS FOR ANOTHER LENGTHENING".THE INVESTIGATION CONCLUDED THAT UNSUCCESSFUL LENGTHENING PROCEDURE REPORTED ON THE 07APRIL22 WAS CAUSED BY A NON FUNCTIONAL DRIVE UNIT. INSPECTION OF THE DEVICE CONFIRMED "NO ROTATION ON POLARITY TEST" NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    AS REPORTED: "THE MAGNET DID NOT LENGTHEN THE IMPLANT. IT WAS MAKING THE NORMAL SOUND LIKE IT WAS WORKING, BUT AFTER X-RAY CONFIRMATION, IT SHOWED NO LENGTHENING. THEY TRIED A SECOND TIME AND AGAIN, NO CHANGE ON X-RAY." SPOKE TO REP. THE REP WAS NOT ONSITE FOR THE ATTEMPTED LENGTHENING, BUT SHE HAD SENT AN EMAIL WITH PICTURES EXPLAINING ALL OF THE CORRECT STEPS FOR A LENGTHENING, INCLUDING USING THE DIRECTION AS REPORTED IN THE DESIGN PROPOSAL AND ALIGNING THE EXTERNAL AND INTERNAL MAGNETS. REP HAD ASKED THE SITE IF THEY HAD BOOSTED THE UNIT. THE SITE REPORTED THE UNIT WAS SET TO 4, WHICH IS INEFFECTUAL, SO THE REP ASKED THEM TO ATTEMPT AT SETTING 3. LENGTHENING AGAIN FAILED. SITE REPORTED THAT THE DRIVE UNIT WAS MAKING A WHIRRING SOUND, BUT IT WAS NOT AS AUDIBLE AS EXPERIENCED IN THE PAST. SURGEON WANTS TO OBTAIN ANOTHER DRIVE UNIT TO LENGTHEN THE EXISTING IMPLANT.

    Description of Event or Problem · 0

    AS REPORTED: "THE MAGNET DID NOT LENGTHEN THE IMPLANT. IT WAS MAKING THE NORMAL SOUND LIKE IT WAS WORKING, BUT AFTER X-RAY CONFIRMATION, IT SHOWED NO LENGTHENING. THEY TRIED A SECOND TIME AND AGAIN, NO CHANGE ON X-RAY." SPOKE TO REP. THE REP WAS NOT ONSITE FOR THE ATTEMPTED LENGTHENING, BUT SHE HAD SENT AN EMAIL WITH PICTURES EXPLAINING ALL OF THE CORRECT STEPS FOR A LENGTHENING, INCLUDING USING THE DIRECTION AS REPORTED IN THE DESIGN PROPOSAL AND ALIGNING THE EXTERNAL AND INTERNAL MAGNETS. REP HAD ASKED THE SITE IF THEY HAD BOOSTED THE UNIT. THE SITE REPORTED THE UNIT WAS SET TO 4, WHICH IS INEFFECTUAL, SO THE REP ASKED THEM TO ATTEMPT AT SETTING 3. LENGTHENING AGAIN FAILED. SITE REPORTED THAT THE DRIVE UNIT WAS MAKING A WHIRRING SOUND, BUT IT WAS NOT AS AUDIBLE AS EXPERIENCED IN THE PAST. SURGEON WANTS TO OBTAIN ANOTHER DRIVE UNIT TO LENGTHEN THE EXISTING IMPLANT. UPDATE 12-MAY-2022: "WE LENGTHENED HIM SUCCESSFULLY ON FRIDAY (B)(6) 2022. THE MAGNET THAT WAS PREVIOUSLY USED WHAT IN FACT THE ISSUE AND IT HAS BEEN SENT IN FOR REPAIR. HERE IS AN XRAY CONFIRMING LENGTHENING. THE PATIENT IS DOING WELL AND WILL COME BACK IN 4 MONTHS FOR ANOTHER LENGTHENING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195930 JTS DRIVE UNIT SET PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE 907-502

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Other