BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM

    MDR report key: 17798265 · Received September 22, 2023

    Report

    Report Number
    3010470577-2022-12071
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    December 13, 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
    BE
    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 BELGIUM REPORTED 4 CASES OF LUCENCY (BORDER ON XRAYS) AROUND THE TIBIAL COMPONENT ASSOCIATED TO PAIN FOR 4 OF HIS PATIENTS (2 OF THEM MIGHT NEED A REVISION SURGERY LATER): PATIENT NUMBER: 12 = LUCENCY WITH PAIN REPORTED 1 YEAR POST-OPERATIVE; PATIENT NUMBER: 14 = LUCENCY WITH PAIN REPORTED 6 MONTHS POST-OPERATIVE; PATIENT NUMBER: 16 = LUCENCY WITH PAIN REPORTED 6 MONTHS POST-OPERATIVE; PATIENT NUMBER: 17 = LUCENCY WITH PAIN REPORTED 4 MONTHS POST-OPERATIVE. ADDITIONAL INFORMATION COMMUNICATED BY THE SURGEON: FOR PATIENT 12 = INFORMATION COMMUNICATED DURING MEETING ON (B)(6) 2023: THE SIGNIFICANT LUCENCY REPORTED FOR PATIENT 12 MIGHT HAVE BEEN INDUCED BY A USER ERROR DURING THE INITIAL SURGERY (10° OF VALGUS INDUCED BY ERROR WHEN USING THE PSI). FOR PATIENT 14 = INFORMATION COMMUNICATED DURING MEETING ON (B)(6) 2023: YOUNG PATIENT, VERY ACTIVE, THAT HAD AN ACTIVE REEDUCATION. THE PATIENT HAD AN INFILTRATION FOR PAIN MANAGEMENT AND WILL BE CLOSELY MONITORED. A SMALL ARTIFACT SEEMS TO BE PRESENT AROUND THE TIBIAL IMPLANT. ADDITION INFORMATION RECEIVED BY IN2BONES ON MARCH 2ND, 2023 (E-MAIL): THE PATIENT HAS BEEN REVIEWED BY THE SURGEON (9 MONTHS POST-OPERATIVE), IT SEEMS THAT A SMALL FRAGMENT OF COATING HAS BEEN DETACHED FROM THE TIBIAL IMPLANT. FOR PATIENT 16 = INFORMATION COMMUNICATED DURING MEETING ON (B)(6) 2023: THIS PATIENT ALSO HAS AN IMPORTANT TIBIAL PERIOSTEAL REACTION, AND THE TIBIAL IMPLANT LUCENCY IS ASSOCIATED TO A TILT OF THE TIBIAL IMPLANT. THIS PATIENT IS CLOSELY MONITORED AND MIGHT NEED A REVISION SURGERY. ADDITIONAL INFORMATION COMMUNICATED DURING MEETING ON (B)(6) 2023 : A REVISION SURGERY IS BEING PLANNED FOR THIS PATIENT. FOR PATIENT 17 = INFORMATION COMMUNICATED DURING MEETING ON (B)(6) 2023: FOR THIS PATIENT, THE LUCENCY MIGHT BE RELATED TO AN INSUFFICIENT IMPACTION OF THE TIBIAL IMPLANT INTRA-OPERATIVELY. THIS PATIENT HAS OSTEOPOROTIC BONES. A REVISION SURGERY MIGHT BE REQUIRED FOR THIS PATIENT AT A LATER DATE. ADDITIONAL INFORMATION COMMUNICATED DURING MEETING ON (B)(6) 2023 : A REVISION SURGERY IS BEING PLANNED FOR THIS PATIENT.

    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 BELGIUM REPORTED 4 CASES OF LUCENCY (BORDER ON XRAYS) AROUND THE TIBIAL COMPONENT ASSOCIATED TO PAIN FOR 4 OF HIS PATIENTS (2 OF THEM MIGHT NEED A REVISION SURGERY LATER): . PATIENT NUMBER 12 = LUCENCY WITH PAIN REPORTED 1 YEAR POST-OPERATIVE; . PATIENT NUMBER 14 = LUCENCY WITH PAIN REPORTED 6 MONTHS POST-OPERATIVE; . PATIENT NUMBER 16 = LUCENCY WITH PAIN REPORTED 6 MONTHS POST-OPERATIVE; . PATIENT NUMBER 17 = LUCENCY WITH PAIN REPORTED 4 MONTHS POST-OPERATIVE. ADDITIONAL INFORMATION ARE TO BE COLLECTED AND INVESTIGATIONS ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104984 QUANTUM QUANTUM® TIBIAL IMPLANT HSN IN2BONES SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other