BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM®

    MDR report key: 23093679 · Received September 19, 2025

    Report

    Report Number
    3010470577-2023-03361
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    March 31, 2023
    Report Date
    September 19, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HSN
    UDI-DI
    03701337601393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORD 1906306 REVIEWED AND FOUND TO BE DOCUMENTARY COMPLIANT. 15 PRODUCTS WERE MANUFACTURED AS PER OF-190370 RELEASED ON OCTOBER 09TH 2020. THE REVIEW DID NOT IDENTIFY ANY INCIDENTS RELATED TO THE MANUFACTURE OF THIS IMPLANT. AS PER REPORTED BY THE INITIATOR, THE SURGEON'S ANALYSIS POINTS TO EXCESSIVE STRESS ON THE TIBIAL ANCHORAGE IN THE TIBIOTALAR JOINT, DUE TO THE STRESSES TRANSFERRED TO THE ANKLE BECAUSE OF THE TALOCALCANEAL ARTHRODESIS, ASSOCIATED WITH AN EARLY RELOADING OF THE ANKLE FOR A PATIENT WITH AN ABOVE AVERAGE FUNCTIONAL DEMAND. TOO EARLY STRESS ON THE ANKLE WITHOUT A SUFFICIENT PERIOD OF IMMOBILIZATION AFTER AN ANKLE SURGERY. EXCESSIVE STRESS ON THE TIBIAL ANCHORAGE IN THE TIBIOTALAR JOINT, DUE TO THE STRESSES TRANSFERRED TO THE ANKLE BECAUSE OF THE TALOCALCANEAL ARTHRODESIS.

    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: PATIENT MALE 46 YEARS OLD OPERATED WITH A QUANTUM PROSTHESIS ON (B)(6) 2022, (B)(6) CLINIC - (B)(6) DOCTOR (B)(6). AT 10 MONTHS THE PATIENT IS IN PAIN. UNDER ANTI-INFLAMMATORY TREATMENT. THE RADIOGRAPH SHOWS A LUCENCY PROXIMAL TO THE BASE OF THE TIBIAL IMPLANT. WE ALSO NOTICE THE FORMATION OF ANTERIOR AND POSTERIOR OSTEOPHYTES AS WELL AS THE FORMATION OF PERIOSTEAL APPOSITIONS. THE PATIENT HAS AN ABOVE-AVERAGE FUNCTIONAL DEMAND (GYM MANAGER). THE PATIENT UNDERWENT A SUBTALAR ARTHRODESIS PRIOR TO THE QUANTUM TOTAL ANKLE PROSTHESIS. EARLY RELOADING < 10 DAYS, WITHOUT POST-OPERATIVE IMMOBILIZATION (CAST) BUT WITH A WALKING BOOT. THE SURGEON'S ANALYSIS TENDS TOWARDS TOO MUCH STRESS ON THE TIBIAL ANCHORING IN THE TIBIOTALAR JOINT LINKED TO THE STRESSES REPORTED ON THE ANKLE DUE TO THE TALOCALCANEAL ARTHRODESIS. HE OFFERS THE PATIENT A PARTIAL SURGICAL REVISION OF THE TIBIAL IMPLANT ONLY WITH MINIMAL TIBIAL RECOVERY AND CEMENTED REIMPLANTATION OF A NEW QUANTUM TIBIAL IMPLANT AND POLYETHYLENE INSERT. THE TALAR IMPLANT REMAINS IN PLACE. THIS REPORTABLE EVENT IS PART OF A REMEDITION RESULTING FROM A 483 LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269269 QUANTUM® QUANTUM® TIBIAL IMPLANT STANDARD HSN IN2BONES SAS 1906306 03701337601393

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention