BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS DRIVE UNIT SET

    MDR report key: 14526666 · Received May 27, 2022

    Report

    Report Number
    3004105610-2022-00085
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    May 5, 2022
    Report Date
    August 12, 2022
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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). IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. 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 NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. 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 EVENTS FOR THE LOT REFERENCED. CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE UNSUCCESSFUL LENGTHENING PROCEDURE REPORTED ON THE (B)(6) 22 WAS CAUSED BY IMPROPER SEATING OF THE PATIENT LEG, ON THE (B)(6) 2022 IT WAS REPORTED THAT THE SECOND LENGTHENING ATTEMPT WAS SUCCESSFUL THEY STATED" [..] APPARENTLY, THE PATIENT LEG WAS NOT PLACED PROPERLY INSIDE THE MAGNETIC COIL: REASON OF THE FAILURE. IT WORKS WELL THE SECOND TIME." A REVIEW OF THE LENGTHENING PROTOCOL & OPERATION MANUAL, NOTED THE FOLLOWING: IN THE SECTION TITLED "PATIENT POSITIONING" IT STATES "[..] THE PATIENT SHOULD BE POSITIONED COMFORTABLY SITTING IN A CHAIR WITH THEIR HIPS THE SAME HEIGHT AS THE CENTER OF THE MAGNETIC COIL [..] PLEASE USE PROPER CUSHIONING SO THAT THE PATIENT¿S LIMB IS ADEQUATELY SUPPORTED DURING THE LENGTHENING [..]". 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

    IT HAS BEEN REPORTED THERE WAS A FAILED LENGTHENING. ON (B)(6) 2022 ANOTHER LENGTHENING IS SCHEDULED WITH THE SAME DRIVE UNIT. UPDATE (B)(6) 2022 THE LENGTHENING ON (B)(6) 2022 WAS SUCCESSFUL.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THERE WAS A FAILED LENGTHENING. ON (B)(6) 22 ANOTHER LENGTHENING IS SCHEDULED WITH THE SAME DRIVE UNIT. UPDATE (B)(6) 22 THE LENGTHENING ON (B)(6) 22 WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1876380 JTS DRIVE UNIT SET PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE 907-234

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male Other