BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM®

    MDR report key: 23095536 · Received September 19, 2025

    Report

    Report Number
    3010470577-2023-11651
    Event Type
    Injury
    Date Received
    September 19, 2025
    Report Date
    September 19, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HSN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE VARIOUS REQUESTS AND REMINDERS, NO ADDITIONAL INFORMATION WERE COMMUNICATED. AS THE REVISION SEEMS TO BE DUE TO UNSUITABLE INITIAL PLACEMENT OF THE TALAR IMPLANT, THE MOST PROBABLE ROOT CAUSE WOULD BE A USER ERROR. NOTE: THIS REPORTABLE EVENT IS PART OF A REMEDIATION 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: INFORMATION VERBALLY COMMUNICATED BY MARKETING DEPARTMENT ON NOVEMBER 30TH, 2023; REGARDING THE REALIZATION OF A REVISION SURGERY BY DR. (B)(6) IN IRELAND DUE TO AN UNSUITABLE PLACEMENT OF THE TALAR COMPONENT OF A QUANTUM PROSTHESIS. DESPITE VARIOUS REQUESTS AND REMINDERS, NO ADDITIONAL INFORMATION WERE COMMUNICATED TO THE QARA TEAM, THUS, THE DECISION HAS BEEN TAKEN TO DOCUMENT THE INCIDENT WITH THE INFORMATION AVAILABLE. TO DATE, THE FOLLOWING INFORMATION ARE NOT AVAILABLE: TRACEABILITY OF THE PROSTHESIS COMPONENTS (INITIAL AND REVISION SURGERIES). DATES OF SURGERIES (INITIAL AND REVISION). PATIENT INFORMATION. TYPE OF REVISION PERFORMED (COMPLETE OR JUST REPLACEMENT OF THE TALAR IMPLANT AND INSERT). SUCCESS OF THE REVISION. NOTE: THIS REPORTABLE EVENT IS PART OF A REMEDIATION RESULTING FROM A 483 LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766992 QUANTUM® QUANTUM® TOTAL ANKLE PROSTHESIS HSN IN2BONES SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention