BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM®

    MDR report key: 23083115 · Received September 18, 2025

    Report

    Report Number
    3010470577-2025-10121
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    October 11, 2022
    Report Date
    September 18, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HSN
    UDI-DI
    03701337602260
    PMA / PMN Number
    K191380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORD 1906370 WAS REVIEWED AND FOUND TO BE COMPLIANT: (B)(4) PRODUCTS WERE MANUFACTURED AS PER (B)(4) AND RELEASED ON JANUARY 06TH, 2021. BATCH RECORD 2002121 WAS REVIEWED AND FOUND TO BE COMPLIANT: (B)(4) PRODUCTS WERE MANUFACTURED AS PER (B)(4) AND RELEASED ON JANUARY 05TH, 2021. BATCH RECORD 2106170 WAS REVIEWED AND FOUND TO BE COMPLIANT: (B)(4) PRODUCTS WERE MANUFACTURED AS PER (B)(4) AND RELEASED ON NOVEMBER 08TH, 2021. AS PER REPORTED BY THE INITIATOR, THE SURGEON BELIEVED THAT THE INCIDENT WAS NOT CAUSED NOR RELATED TO THE IMPLANT. INFECTION, NOT RELATED TO THE IMPLANTED DEVICE, IS A KNOWN ADVERSE EVENT FOLLOWING A FOOT SURGERY. THIS TYPE OF ADVERSE EVENT IS DOCUMENTED IN THE QUANTUM IFU AND TECHNICAL DOCUMENTATION. THIS INCIDENT IS THE FIRST CASE OF INFECTION REPORTED AFTER A QUANTUM SURGERY.

    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: AS REPORTED BY IN2BONES USA (EMAIL DATED ON OCTOBER 12TH, 2022): « A COMPLAINT WAS RECEIVED FOR QUANTUM TOTAL ANKLE SYSTEM. SALES REP BILLY ORTIZ REPORTED THAT DR. SCOTT CARRINGTON (GUNDERSEN HEALTH SYSTEM) REMOVED QUANTUM IMPLANTS POSTOPERATIVELY DUE TO A PATIENT INFECTION. ACCORDING TO THE SURGEON, THE INFECTION WAS NOT CAUSED BY OR RELATED TO THE IMPLANT. THE DATE OF SURGERY WAS (B)(6) 2022. AWARE DATE IS 10-11-2022. THE PARTS HAVE NOT BEEN RETURNED TO IN2BONES, USA. PRODUCT INFORMATION: PART NUMBER. LOT NUMBER . DESCRIPTION. M50 SU155 1906370 QUANTUM FIXED INSERT IMPLANT SIZE 5 RIGHT 5MM. M50 SC145 2002121 QUANTUM TALAR IMPLANT FLAT CUT RIGHT SIZE 5. M50 ST160 2106170 QUANTUM TIBIAL IMPLANT STAND RIGHT SIZE 6. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 12TH, 2022 : THE PROSTHESIS WAS COMPLETELY REMOVED AND REPLACED BY AN ANTIBIOTIC SPACER CIMENT BLOCK. THIS EVENT IS REPORTED ACCORDING THE REMEDIATION PLAN FOLLOWING FDA OBSERVATION 1 FROM 04-SEPT-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647983 QUANTUM® QUANTUM® TOTAL ANKLE PROSTHESIS HSN IN2BONES SAS 1906370; 2002121; 2106170 03701337602260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other