BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM®

    MDR report key: 19048765 · Received April 5, 2024

    Report

    Report Number
    3010470577-2024-03041
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    March 6, 2024
    Report Date
    June 14, 2024
    Manufacturer
    IN2BONES SAS
    Product Code
    HSN
    PMA / PMN Number
    K191380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN2BONES WILL CONTINUE TO MONITOR AND RECORD SUCH EVENTS, IF ANY. IF ADDITIONAL INFORMATION ARE RECEIVED ON THIS INCIDENT, AN UPDATE OF THIS VIGILANCE REPORT WILL BE 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 : AN IRISH SURGEON IS PLANNING A PROSTHESIS REVISION SURGERY FOR ONE OF HIS PATIENTS. AT THE 9 MONTHS FOLLOW-UP, THE CONTROL CT SCAN SHOWS A TILTED TIBIAL COMPONENT AND A DISLOCATED INSERT. THE PATIENT IS ASYMPTOMATIC. THE PATIENT PREVIOUSLY HAD AN ARTHRODESIS OF THE TALUS NAVICULAR AND FIRST CUNEIFORM BONE. THE REVISION HAS NOT BEEN PERFORMED YET (NO PLANNED DATE COMMUNICATED), BUT THE SURGEON PLANS TO REVISE THE TIBIAL COMPONENT WITH A BONE RECUT TO CORRECT THE SLOPE AND CEMENTING OF THE NEW TIBIAL IMPLANT. THE INSERT WILL ALSO BE CHANGED BUT NO REVISION OF THE TALAR COMPONENT. ADDITONAL INFORMATION ARE TO BE COLLECTED AND INVESTIGATIONS ARE IN PROGRESS.

    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 : AN IRISH SURGEON IS PLANNING A PROSTHESIS REVISION SURGERY FOR ONE OF HIS PATIENTS. AT THE 9 MONTHS FOLLOW-UP, THE CONTROL CT SCAN SHOWS A TILTED TIBIAL COMPONENT AND A DISLOCATED INSERT. THE PATIENT IS ASYMPTOMATIC. THE PATIENT PREVIOUSLY HAD AN ARTHRODESIS OF THE TALUS NAVICULAR AND FIRST CUNEIFORM BONE. THE REVISION HAS NOT BEEN PERFORMED YET (NO PLANNED DATE COMMUNICATED), BUT THE SURGEON PLANS TO REVISE THE TIBIAL COMPONENT WITH A BONE RECUT TO CORRECT THE SLOPE AND CEMENTING OF THE NEW TIBIAL IMPLANT. THE INSERT WILL ALSO BE CHANGED BUT NO REVISION OF THE TALAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298522 QUANTUM® QUANTUM® TOTAL ANKLE PROSTHESIS HSN IN2BONES SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention