BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM®

    MDR report key: 23084903 · Received September 18, 2025

    Report

    Report Number
    3010470577-2023-03061
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    February 21, 2023
    Report Date
    September 18, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HSN
    UDI-DI
    03701337601461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH HISTORY RECORDS OF THE PRODUCT INVOLVED IN THIS COMPLAINT WAS REVIEWED AND NO NON-CONFORMITY WHICH MIGHT EXPLAIN THE COMPLAINT WAS FOUND. THERE IS NO IDENTIFIED LINK BETWEEN THE BATCH INVOLVED IN THIS COMPLAINT AND ITS MANUFACTURING PROCESSES. AS NO DEVICE RETURNED TO IN2BONES, NO SPECIFIC ANALYSIS OR TESTS COULD BE PERFORMED ON THE INVOLVED PART. THE DEVICE WAS NOT RETURNED, BUT PICTURES WERE PROVIDED : THE DEFECT REPORTED IS VISUALLY CONFIRMED (A COATING PART OF THE IMPLANT IS BROKEN). NO PART OF THE COATING SEEMS TO BE MISSING, THUS NO BROKEN FRAGEMENT WAS LEFT IMPLANTED. THE DESIGN OF THE TIBIAL IMPLANT AND ITS COATING ARE NOT QUESTIONED BY THE INCIDENT REPORTED. AS DESCRIBED BY THE COMPLAINT INITIATOR: THE TIBIAL IMPLANT HAD BEEN INITIALLY IMPLANTED BUT AS ITS IMPACTION WAS NOT DEEMED SUFFICIENT, THE SURGEON DECIDED TO REMOVE IT TO COMPLETE THE TIBIAL CROSS PREPARATION WITHOUT THE DEDICATED INSTRUMENTS. THE PARTIAL DAMAGE OF THE COATING, BEING IN THE EXTERIOR PART OF THE IMPLANT AND HAVING BEEN DETECTED AFTER ITS EXPLANTATION, IS MOST PROBABLY DUE TO THE MANUALLY REMOVAL OF THE IMPLANT PERFORMED INTRAOPERATIVELY. NOTE: THIS REPORTABLE EVENT IS PART OF A REMEDITION RESULTING FROM A 483 LETTER.

    Description of Event or Problem · 0

    MEDICAL DEVICE DESCRIPTION: THE QUANTUM® TOTAL ANKLE PROSTHESIS IS A FIXED-BEARING SEMI-CONSTRAINT ANKLE PROTHESIS WITH 2 COMPONENTS EXISTING IN DIFFERENT SIZES AND MODELS AND COMPOSED OF: - A TIBIAL COMPONENT COMPOSED OF A METALLIC (TA6V) TIBIAL TRAY IMPLANT FIXED TO A POLYMER (UHWMPE) INSERT, - A METALLIC (COCR) TALAR IMPLANT REPRODUCING THE TALUS DOME ANATOMY. WHEN ALL COMPONENTS ARE IMPLANTED, WITH THE INSERT RIGIDLY LOCKED TO THE TIBIAL TRAY, THE POLYETHYLENE INSERT ACTS AS A SINGLE BEARING ALONG THE TALAR DOME, ENABLING FLEXION/EXTENSION AND ROTATION MOVEMENT AT THE REPLACED ANKLE JOINT. EACH COMPONENT OF THE QUANTUM® TOTAL ANKLE PROSTHESIS EXISTS IN DIFFERENT SIZES AND MODELS. EVENT DESCRIPTION : SURGICAL INTERVENTION TO INSTALL A QUANTUM TOTAL ANKLE PROSTHESIS WITH PATIENT SPECIFIC CUTTING GUIDES. DUE TO DIFFICULTIES IN HAVING A COMPLETE IMPACTION OF THE TIBIAL IMPLANT (SCOPIC CONTROL), THE IMPLANT WAS REMOVED MANUALLY (WITHOUT USING INSTRUMENT) IN ORDER TO BE REPOSITIONED AFTER ADDITIONAL PREPARATION WITH THE FIXATION CROSS PREPARATION INSTRUMENTS. THE IMPLANT WAS PLACED ON THE INSTRUMENTATION TABLE, AND THEN IT WAS NOTICED THAT PART OF THE ANTEROMEDIAL COATING OF THE IMPLANT (TITANIUM SPRAY) HAD SEPARATED FROM THE IMPLANT. IT WAS UNTHINKABLE TO REPOSITION THIS TIBIAL IMPLANT WITH AN AREA WITHOUT COATING FOR BONE INTEGRATION. IT WAS USED ANOTHER IMPLANT AS 2 SETS OF IMPLANTS FOR ALL PROSTHETIC SIZES ARE AVAILABLE, WHICH ALLOWED TO RESOLVE THE PROBLEM WITHOUT CONSEQUENCES FOR THE PATIENT. THE PARTIAL DAMAGE OF THE COATING, BEING IN THE EXTERIOR PART OF THE IMPLANT AND HAVING BEEN DETECTED AFTER ITS EXPLANTATION, IS MOST PROBABLY DUE TO THE REMOVAL OF THE IMPLANT PERFORMED INTRAOPERATIVELY. NO BROKEN FRAGMENT WAS LEFT IMPLANTED. NOTE: THIS REPORTABLE EVENT IS PART OF A REMEDITION RESULTING FROM A 483 LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2824815 QUANTUM® QUANTUM® TOTAL ANKLE PROSTHESIS HSN IN2BONES SAS 1906297 03701337601461

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male