BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM®

    MDR report key: 23140947 · Received September 25, 2025

    Report

    Report Number
    3010470577-2024-10011
    Event Type
    Injury
    Date Received
    September 25, 2025
    Date of Event
    October 10, 2024
    Report Date
    September 25, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HSN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORDS HAVE BEEN ASSESSED AND THERE WAS NO DETECTED NON-CONFORMITY WHICH MAY EXPLAIN THE ISSUE REPORTED IN THIS COMPLAINT. AS PER INFORMATION RECEIVED ON 30-DEC-2024, IT IS CONFIRMED THAT THE REVISION WAS CAUSED BY AN INFECTION, NOT RELATED TO THE IMPLANT. DURING THE REVISION SURGERY, IT WAS OBSERVED THAT "THE IMPLANTS WERE PERFECT IN APPEARANCE, WITH NO DETERIORATION OR DAMAGE". IT WAS REPORTED THAT THE PATIENT IS "FEMALE, ABOUT 70 YEARS OLD, OVERWEIGHT AND DID NOT FOLLOW THE PROTOCOLS ESTABLISHED BY THE SURGEON FOR PROPER RECOVERY.". IN ADDITION, IT IS REPORTED THAT THE REVISION WAS CAUSED BY AN INFECTION, NOT RELATED TO THE IMPLANT ITSELF, HOWEVER, THERE IS NO EVIDENCE OF THE CAUSE OF THE INFECTION, SO NO FURTHER INFORMATION REGARDING THE CIRCUMSTANCE OF THE EVENT. INFECTION IS A KNOWN ADVERSE EVENT FOLLOWING A FOOT SURGERY; AND THIS TYPE OF ADVERSE EVENT IS DOCUMENTED IN THE QUANTUM IFU AND TECHNICAL DOCUMENTATION.

    Description of Event or Problem · 0

    MEDICAL DEVICE DESCRIPTION: THE QUANTUM® TOTAL ANKLE PROSTHESIS IS A FIXED-BEARING SEMI-CONSTRAINT ANKLE PROTHESIS WITH 2 COMPONENTS EXISTING IN DIFFERENT SIZES AND MODELS 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 SURGEON IS SCHEDULING AN EARLY REVISION OF A QUANTUM PATIENT (INITIAL SURGERY DATE UNKNOWN). THE REVISION IS SCHEDULED FOR ON (B)(6) 2024; THE SURGEON IS PLANNING ON USING THE MANUAL JIG. ACCORDING TO THE SALES REP. FROM CONMED IBERIA (EMAIL RECEIVED ON 30-DEC-2024), IT IS REPORTED THAT "THE REASON FOR THE REPLACEMENT WAS AN INFECTION OF THE PATIENT NOT RELATED TO THE IMPLANT, BUT FOR PREVENTIVE REASONS THE IMPLANT WAS REMOVED AT FIRST AND IN A SECOND TIME THE OPTION OF A NEW PROSTHESIS OR AN ARTHRODESIS WAS CONSIDERED, AS IT WAS FINALLY DONE.". IN ADDITION, THE DATE ON (B)(6) 2024 FOR REVISION SURGERY IS CONFIRMED, WITH "CORRECT EVOLUTION IN THE REVISION" AS "THE SECOND SURGERY WAS SUCCESSFUL AND THE PATIENT IS LIVING A NORMAL LIFE.". REGARDING THE IMPLANTS REMOVED DURING THE REVISION, "THE IMPLANTS WERE PERFECT IN APPEARANCE, WITH NO DETERIORATION OR DAMAGE.". REGARDING THE PATIENT, IT IS REPORTED THE FOLLOWING: "FEMALE, ABOUT 70 YEARS OLD, OVERWEIGHT AND DID NOT FOLLOW THE PROTOCOLS ESTABLISHED BY THE SURGEON FOR PROPER RECOVERY." NOTE: THIS REPORTABLE EVENT IS PART OF A REMEDITION RESULTING FROM A 483 LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850391 QUANTUM® QUANTUM® TOTAL ANKLE PROSTHESIS HSN IN2BONES SAS 2203003 / 2112099 / 2202133

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention