BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS DRIVE UNIT

    MDR report key: 9353804 · Received November 21, 2019

    Report

    Report Number
    3004105610-2019-00122
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    September 6, 2019
    Report Date
    January 23, 2020
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON INITIAL RECEIPT OF THE REPORTED EVENT, THE EVENT DESCRIPTION WAS REVIEWED AND WITH THE LIMITED INFORMATION AVAILABLE AT THAT TIME, A DECISION WAS MADE TO REPORT THE EVENT. THE INVESTIGATION CONFIRMED THAT THIS UNIT WAS FUNCTIONAL AND DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE EVENT IS THEREFORE, NOT REPORTABLE.

    Description of Event or Problem · 0

    THIS PI IS CREATED FOR THE FIRST ATTEMPT LAST 25 OF AUGUST. IT IS REPORTED " FIRST ATTEMPT HAS BEEN PERFORMED WITH NO SUCCESS LAST 25 OF AUGUST WITH POWER UNIT SET ON 0. SECOND ATTEMPT TODAY." ADDITIONAL NOTES STATE "CENTER IS EXPOSED TO JTS SYSTEM, NEVER GOT PROBLEMS BEFORE. SAME SKILLED PHYSICIAN AS IN THE PAST. IT HAS BEEN TRIED SEVERAL TIME THE UNLOCKING PROCEDURE TO SWITCH FROM B TO A. POWER UNIT SET ON 3 AND 4. IMPLANT SOUNDED AS LOCKED, SOUNDED WORKING GOING REVERSE (B) AND THEN GOING AHEAD (A) BUT JUST FOR A FEW SECONDS. "

    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

    THIS PI IS CREATED FOR THE FIRST ATTEMPT LAST 25 OF AUGUST. IT IS REPORTED " FIRST ATTEMPT HAS BEEN PERFORMED WITH NO SUCCESS LAST 25 OF AUGUST WITH POWER UNIT SET ON 0. SECOND ATTEMPT TODAY." ADDITIONAL NOTES STATE "CENTER IS EXPOSED TO JTS SYSTEM, NEVER GOT PROBLEMS BEFORE. SAME SKILLED PHYSICIAN AS IN THE PAST. IT HAS BEEN TRIED SEVERAL TIME THE UNLOCKING PROCEDURE TO SWITCH FROM B TO A. POWER UNIT SET ON 3 AND 4. IMPLANT SOUNDED AS LOCKED, SOUNDED WORKING GOING REVERSE (B) AND THEN GOING AHEAD (A) BUT JUST FOR A FEW SECONDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150404 JTS DRIVE UNIT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE 907-110

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other