BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS DRIVE UNIT SET

    MDR report key: 13768196 · Received March 15, 2022

    Report

    Report Number
    3004105610-2022-00026
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Date of Event
    February 22, 2022
    Report Date
    May 31, 2022
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    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: THE REPORTED DEVICE IS A JTS DRIVE UNIT, SN: (B)(6) . METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION OF THE JTS COIL REPORTED, SHOWED OVERALL GENERAL WEAR AND TEAR ON THE PRODUCT. BOTH THE MAGNETIC COIL AND THE POWER UNIT CONSOLE SHARE THE SAME SERIAL NUMBER ¿(B)(6)¿ AND BOTH DEVICES STATE THE DATE OF MANUFACTURE IS ¿MAR 2014¿. DIMENSIONAL INSPECTION: NOT PERFORMED AS NOT RELEVANT TO THE REPORTED EVENT. FUNCTIONAL INSPECTION: THE DRIVE UNIT MLE3 LOT: (B)(6) PASSED THE ANNUAL MAINTENANCE/ FUNCTION TEST. MATERIAL ANALYSIS: NOT PERFORMED AS NOT RELEVANT TO THE REPORTED EVENT. CLINICIAN REVIEW: N/A. DEVICE HISTORY REVIEW: REVIEW OF THE ANNUAL MAINTENANCE AND FUNCTIONAL INSPECTION INDICATES THE DEVICE CONFORMED TO REQUIREMENTS. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS. CONCLUSION. THE JTS DRIVE UNIT ((B)(6)) PASSED ITS ANNUAL MAINTENANCE TEST, CONFIRMING THAT DRIVE UNIT IS WORKING ACCORDINGLY. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING OPERATIVE REPORTS, PATHOLOGY REPORTS, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 0

    FAILED LENGTHENING REPORTED.

    Description of Event or Problem · 0

    FAILED LENGTHENING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663866 JTS DRIVE UNIT SET PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other