BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM

    MDR report key: 17798331 · Received September 22, 2023

    Report

    Report Number
    3010470577-2022-12161
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    December 19, 2022
    Report Date
    September 22, 2023
    Manufacturer
    IN2BONES SAS
    Product Code
    HSN
    PMA / PMN Number
    K191380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATIONS ARE IN PROGRESS. A COMPLETE AND FINAL MDR REPORT WILL BE SUBMITTED WHEN ALL INVESTIGATIONS ARE PERFORMED.

    Description of Event or Problem · 0

    THE QUANTUM® TOTAL ANKLE PROSTHESIS IS INDICATED AS A TOTAL ANKLE REPLACEMENT IN PRIMARY OR REVISION SURGERY FOR PATIENTS WITH ANKLE JOINTS DAMAGED BY SEVERE RHEUMATOID, POST-TRAUMATIC, OR DEGENERATIVE ARTHRITIS. THE QUANTUM® TOTAL ANKLE PROSTHESIS IS A FIXED-BEARING, SEMI-CONSTRAINT ANKLE PROTHESIS WITH 2 COMPONENTS 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 : ONE SURGEON BASED IN FRANCE REPORTED 6 CASES OF LUCENCY (BORDERS ON XRAYS) AROUND THE TIBIAL COMPONENT ASSOCIATED TO PAIN FOR 5 OF HIS PATIENTS (3 OF THEM MIGHT NEED A REVISION SURGERY LATER). ADDITIONAL INFORMATION RECEIVED: . ONE OF THE 5 INITIAL PATIENTS ALSO HAS A MIGRATION OF HERS/HIS TIBIAL COMPONENTS; . TOW OF THE 5 INITIAL PATIENTS HAVE HAD REVISION SURGERIES PERFORMED BY THE SURGEON + 2 WILL BE PERFORMED AT A LATER DATE; . AN ADDITIONAL PATIENT HAS BEEN INTEGRATED ON THIS COMPLAINT FOR A REVISION DUE TO LUCENCIES AROUND THE TIBIAL COMPONENT.

    Description of Event or Problem · 0

    THE QUANTUM® TOTAL ANKLE PROSTHESIS IS INDICATED AS A TOTAL ANKLE REPLACEMENT IN PRIMARY OR REVISION SURGERY FOR PATIENTS WITH ANKLE JOINTS DAMAGED BY SEVERE RHEUMATOID, POST-TRAUMATIC, OR DEGENERATIVE ARTHRITIS. THE QUANTUM® TOTAL ANKLE PROSTHESIS IS A FIXED-BEARING, SEMI-CONSTRAINT ANKLE PROTHESIS WITH 2 COMPONENTS 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 : ONE SURGEON BASED IN FRANCE REPORTED 6 CASES OF LUCENCY (BORDERS ON XRAYS) AROUND THE TIBIAL COMPONENT ASSOCIATED TO PAIN FOR 5 OF HIS PATIENTS (3 OF THEM MIGHT NEED A REVISION SURGERY LATER). ADDITIONAL INFORMATION ARE TO BE COLLECTED AND INVESTIGATIONS ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353605 QUANTUM QUANTUM® TIBIAL IMPLANT HSN IN2BONES SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O