BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS COIL

    MDR report key: 9706423 · Received February 13, 2020

    Report

    Report Number
    3004105610-2020-00028
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    December 19, 2019
    Report Date
    March 23, 2020
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    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) . REPORTED EVENT: AN EVENT REGARDING NON FUNCTIONING JTS DRIVE UNIT WAS REPORTED. THE EVENT WAS CONFIRMED BY PRODUCT INSPECTION. METHOD AND RESULTS: PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION - PICTURES OF THE JTS POWER UNIT, JTS COIL AND CABLES WERE TAKEN. VISUAL INSPECTION OF THE JTS POWER UNIT REPORTED THAT MINOR SIGNS OF DAMAGE WERE FOUND ON THE UPPER AND LATERAL SURFACES. MOREOVER, THE LABEL REPORTING THE LATEST ANNUAL MAINTENANCE WAS MISSING. THE JTS COIL SHOWED MINOR SCRATCHES ON THE LATERAL SIDE. CABLES DID NOT SHOW ANY VISIBLE DAMAGE. FUNCTIONAL INSPECTION - NOT PERFORMED AS THE ITEM WAS RETURNED DAMAGED. PRODUCT HISTORY REVIEW: REVIEW OF THE INSPECTION RECORDS REPORTED THAT THE JTS DRIVE UNIT PASSED THE ANNUAL MAINTENANCE ON THE (B)(6) 19 WITHOUT DISCREPANCIES. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION THE COMPLAINT DATABASES WERE REVIEWED FROM (B)(6) 2017 TO PRESENT FOR SIMILAR EVENTS REGARDING JTS DRIVE UNIT NOT FUNCTIONING. THERE HAVE BEEN 6 SIMILAR EVENTS. CONCLUSIONS: AN EVENT REGARDING NON FUNCTIONING JTS DRIVE UNIT WAS REPORTED. THE EVENT WAS CONFIRMED BY PRODUCT INSPECTION, DURING WHICH THE DEVICE WAS FOUND DAMAGED. THE SALES REP REPORTED ON THE (B)(6) 2019 THAT THE IMPLANT HAS NOT ONLY FAILED TO EXTEND, BUT ALSO REDUCED IN HEIGHT; HOWEVER, HE ALSO REPORTED ON THE (B)(6) 2020 THAT THE PATIENT WAS SUCCESSFULLY EXTENDED OF 6MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S JTS DISTAL FEMUR IMPLANT UNDERWENT A SERIES OF VERY IRREGULAR LENGTHENING EVENTS.

    Additional Manufacturer Narrative · 1

    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). AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S JTS DISTAL FEMUR IMPLANT UNDERWENT A SERIES OF VERY IRREGULAR LENGTHENING EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171315 JTS COIL PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other