BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM

    MDR report key: 17797813 · Received September 22, 2023

    Report

    Report Number
    3010470577-2022-09041
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    September 3, 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 : - INITIAL INFORMATION REPORTED BY THE SURGEON ON (B)(6) 2022: THE PATIENT WAS REVIEWED AT HIS/HER 4 MONTHS POSTOPERATIVE FOLLOW-UP. A TILT OF THE TIBIAL COMPONENT OF THE QUANTUM PROSTHESIS WAS IDENTIFIED IN REGARDS TO THE IMMEDIATE POSTOPERATIVE RESULTS, CREATING A VARUS ANGLE (DISPLACEMENT OF THE TIBIAL COMPONENT PLACEMENT BETWEEN THE IMMEDIATE RESULTS AND THE 4 MONTHS RESULTS). HOWEVER, AND AS REPORTED BY THE INITIATOR, THE PATIENT FUNCTIONAL RESULTS AND PAIN LEVELS WERE DEEMED ACCEPTABLE. - ADDITIONAL INFORMATION REPORTED BY THE SURGEON ON (B)(6) 2022: THE PATIENT WAS REVIEWED 3 TIMES BETWEEN (B)(6) AND HAS AN AGGRAVATION OF HIS/HER PAIN LEVEL DESPITE AN INFILTRATION. - ADDITIONAL INFORMATION REPORTED BY THE SURGEON: THIS PATIENT WAS REVISED ON (B)(6) 2023: THE QUANTUM PROSTHESIS WAS REMOVED AND REPLACED BY A COMPETITOR PROSTHESIS WITH CEMENT.

    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 : INITIAL INFORMATION REPORTED BY THE SURGEON ON (B)(6) 2022: THE PATIENT WAS REVIEWED AT HIS/HER 4 MONTHS POSTOPERATIVE FOLLOW-UP. A TILT OF THE TIBIAL COMPONENT OF THE QUANTUM PROSTHESIS WAS IDENTIFIED IN REGARDS TO THE IMMEDIATE POSTOPERATIVE RESULTS, CREATING A VARUS ANGLE (DISPLACEMENT OF THE TIBIAL COMPONENT PLACEMENT BETWEEN THE IMMEDIATE RESULTS AND THE 4 MONTHS RESULTS). HOWEVER, AND AS REPORTED BY THE INITIATOR, THE PATIENT FUNCTIONAL RESULTS AND PAIN LEVELS WERE DEEMED ACCEPTABLE. ADDITIONAL INFORMATION REPORTED BY THE SURGEON ON DECEMBER 12TH, 2022: THE PATIENT WAS REVIEWED 3 TIMES BETWEEN (B)(6) AND (B)(6) AND HAS AN AGGRAVATION OF HIS/HER PAIN LEVEL DESPITE AN INFILTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200857 QUANTUM QUANTUM® TIBIAL IMPLANT HSN IN2BONES SAS M50 ST250 1906284

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| S