BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS DRIVE UNIT

    MDR report key: 10209127 · Received June 29, 2020

    Report

    Report Number
    3004105610-2020-00114
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    June 3, 2020
    Report Date
    September 24, 2020
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION THE PATIENT HAD TWO SUCCESSFUL LENGTHENING PROCEDURES IN (B)(6) 2019. SUBSEQUENTLY THE PATIENT HAD A METASTATIC RELAPSE WITH SURGERY AND CYCLES OF CHEMOTHERAPY. AFTER THE CYCLES, IN (B)(6) 2020, ANOTHER ATTEMPT WAS MADE TO PERFORM THE LENGTHENING WITHOUT SUCCESS AND THE EVENT WAS REPORTED TO COMPLAINTS TEAM. IN TOTAL 5 UNSUCCESSFUL ATTEMPTS WERE MADE WITH 2 DIFFERENT JTS DRIVE UNITS: FROM THIS, IT WAS POSSIBLE TO CONCLUDE THAT THE SEIZING ISSUE WAS NOT CAUSED BY THE JTS DRIVE UNIT BUT, MOST LIKELY, BY PATIENT FACTORS. IF THERE ARE NO REGULAR LENGTHENING INTERVALS, THERE IS A CREATION OF FIBROUS TISSUE AROUND THE DEVICE THAT CAN PREVENT THE DEVICE FROM EXTENDING. BASED ON THE PROVIDED INFORMATION, THE JTS DRIVE UNIT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT AND IS THEREFORE CONSIDERED CONCOMITANT. THEREFORE THIS MDR IS BEING CANCELLED.

    Description of Event or Problem · 0

    AS REPORTED BY A MARKETING ASSOCIATE: "WE HAVE BEEN INFORMED THAT IN A NEW ELONGATION PROCEDURE, AGAIN WE HAVE NOT HAD ANY EXTENSION. A CLINICIAN ASSESSMENT WAS PROVIDED WHICH OUTLINES THE FOLLOWING: IMPLANT DATE (B)(6) 2018, LEFT FEMUR. IN (B)(6) 2019, 7-8MM EXTENSION WAS ACHIEVED IN TWO SESSIONS, 16 MINUTES EACH. IN (B)(6) 2019, PATIENT HAD A METASTATIC RECURRENCE OF CANCER AND UNDERWENT CHEMOTHERAPY. TREATMENT COMPLETED IN (B)(6) 2020. IN (B)(6) 2020, ON THREE DIFFERENT DAYS, ATTEMPTS WERE MADE TO LENGTHEN THE IMPLANT UNSUCCESSFULLY ("TO AN AVERAGE OF 16 MINUTES (4MM) WITHOUT GETTING THE PROSTHESIS TO LENGTHEN"). THE DRIVE UNIT HAD LAST BEEN SERVICED IN (B)(6) 2020. UPDATE AS REPORTED: "UNFORTUNATELY, TODAY THE SECOND LENGTHENING PROCEDURE AND IT¿S X-RAY VERIFICATION WAS DONE WITH NO SUCCESS. THEY TRIED TO LENGTHEN WITH 2 DIFFERENT JTS UNITS WITH NO LENGTHENING AT ALL. THE PROBLEM MUST BE IN THE IMPLANT." AN X-RAY WAS PROVIDED

    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. REVIEW OF THE INSPECTION RECORDS INDICATES THE DEVICE CONFORMED TO REQUIREMENTS, AS REPORTED IN THE ANNUAL MAINTENANCE PERFORMED ON THE 10TH OF MARCH 2020.

    Description of Event or Problem · 1

    AS REPORTED BY A MARKETING ASSOCIATE: "WE HAVE BEEN INFORMED THAT IN A NEW ELONGATION PROCEDURE, AGAIN WE HAVE NOT HAD ANY EXTENSION. A CLINICIAN ASSESSMENT WAS PROVIDED WHICH OUTLINES THE FOLLOWING: IMPLANT DATE (B)(6) 2018, LEFT FEMUR. IN (B)(6) 2019, 7-8MM EXTENSION WAS ACHIEVED IN TWO SESSIONS, 16 MINUTES EACH. IN (B)(6) 2019, PATIENT HAD A METASTATIC RECURRENCE OF CANCER AND UNDERWENT CHEMOTHERAPY. TREATMENT COMPLETED IN (B)(6) 2020. IN (B)(6) 2020, ON THREE DIFFERENT DAYS, ATTEMPTS WERE MADE TO LENGTHEN THE IMPLANT UNSUCCESSFULLY ("TO AN AVERAGE OF 16 MINUTES (4MM) WITHOUT GETTING THE PROSTHESIS TO LENGTHEN"). THE DRIVE UNIT HAD LAST BEEN SERVICED IN (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669929 JTS DRIVE UNIT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE 907-250

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other