BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM®

    MDR report key: 20319597 · Received September 27, 2024

    Report

    Report Number
    3010470577-2024-09051
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    August 27, 2024
    Report Date
    December 23, 2024
    Manufacturer
    IN2BONES SAS
    Product Code
    HSN
    PMA / PMN Number
    K191380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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 : A US PHYSICIAN REPORTED FOR HIS FIRST CASE USING THE QUANTUM TOTAL ANKLE SYSTEM, HE HAD INTRAOPERATIVE COMPLICATIONS WHICH LED TO A PROLONGED CASE. THE END RESULT WAS A SUCCESSFUL SURGERY FOR THE PATIENT. HOWEVER, DURING THE CASE, THE PHYSICIAN HAD TO USE TWO TIBIAL COMPONENTS AND TWO POLY COMPONENTS TO HAVE THE CASE COMPLETED. WHEN THE PHYSICIAN TRIED IMPACTING THE FIRST POLY COMPONENT ONTO THE FIRST TIBIAL COMPONENT, THE POLY COMPONENT WOULD NOT ENGAGE ON THE MEDIAL AND LATERAL SIDE. THE POLY WOULD ENGAGE ON ONE SIDE AND THEN WOULD SLIDE OUT ANTERIORLY WHENEVER THE PATIENT'S RANGE OF MOTION WAS TESTED INTRAOPERATIVELY. A SECOND POLY IMPLANT WAS TESTED WITH THE TIBIAL COMPONENT WITH THE SAME ISSUES. THE SURGEON THEN OPTED TO REMOVE THE TIBIAL PROSTHESIS WITH THE TALAR COMPONENT LEFT IN. THE SECOND POLY COMPONENT WAS TESTED WITH A SECOND TIBIAL PROSTHESIS ON THE BACK TABLE AND THEY CONFIRMED THAT BOTH COMPONENTS WORKED TOGETHER BY HAVING THEM "CLICK TOGETHER" ON THE BACK TABLE. FOLLOWING THIS, THE SECOND TIBIAL AND POLY COMPONENTS WERE IMPLANTED AND IMPACTED TOGETHER. ADDITIONAL 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 : A US PHYSICIAN REPORTED FOR HIS FIRST CASE USING THE QUANTUM TOTAL ANKLE SYSTEM, HE HAD INTRAOPERATIVE COMPLICATIONS WHICH LED TO A PROLONGED CASE. THE END RESULT WAS A SUCCESSFUL SURGERY FOR THE PATIENT. HOWEVER, DURING THE CASE, THE PHYSICIAN HAD TO USE TWO TIBIAL COMPONENTS AND TWO POLY COMPONENTS TO HAVE THE CASE COMPLETED. WHEN THE PHYSICIAN TRIED IMPACTING THE FIRST POLY COMPONENT ONTO THE FIRST TIBIAL COMPONENT, THE POLY COMPONENT WOULD NOT ENGAGE ON THE MEDIAL AND LATERAL SIDE. THE POLY WOULD ENGAGE ON ONE SIDE AND THEN WOULD SLIDE OUT ANTERIORLY WHENEVER THE PATIENT'S RANGE OF MOTION WAS TESTED INTRAOPERATIVELY. A SECOND POLY IMPLANT WAS TESTED WITH THE TIBIAL COMPONENT WITH THE SAME ISSUES. THE SURGEON THEN OPTED TO REMOVE THE TIBIAL PROSTHESIS WITH THE TALAR COMPONENT LEFT IN. THE SECOND POLY COMPONENT WAS TESTED WITH A SECOND TIBIAL PROSTHESIS ON THE BACK TABLE AND THEY CONFIRMED THAT BOTH COMPONENTS WORKED TOGETHER BY HAVING THEM "CLICK TOGETHER" ON THE BACK TABLE. FOLLOWING THIS, THE SECOND TIBIAL AND POLY COMPONENTS WERE IMPLANTED AND IMPACTED TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738436 QUANTUM® QUANTUM® TOTAL ANKLE PROSTHESIS, PRODUCT CODE: HSN HSN IN2BONES SAS M50 ST241 / M50 SU235 2106197 / 2009084

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other