BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM® TOTAL ANKLE PROSTHESIS

    MDR report key: 23142135 · Received September 25, 2025

    Report

    Report Number
    3010470577-2025-01161
    Event Type
    Injury
    Date Received
    September 25, 2025
    Date of Event
    November 15, 2024
    Report Date
    September 25, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HSN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH HISTORY RECORDS OF THE PRODUCTS INVOLVED IN THIS COMPLAINT WERE REVIEWED AND ASSESSED (BATCHES 2106227, 2112080 AND 2210194). NO NON-CONFORMITY WHICH MIGHT EXPLAIN THE COMPLAINT WAS DETERMINED. ONLY A NON-CONFORMITY REPORTED BY THE SUPPLIER REFERENCE (B)(4) WAS RECORDED FOR THE BATCH 2210194 ABOUT AN UNKNOWN SPOT ON ONE PIECE. THIS PIECE WAS DISCARDED. IRRADIATION GAMMA (28,8 - 35,6 KGY) WERE PERFORMED BY THE SUPPLIER (B)(4) AND NO NON-CONFORMITY WAS MENTIONED BY THE SUPPLIER ABOUT THE STERILIZATION OF THE PRODUCT. THEN, THE SEMI-FINISHED PRODUCTS BATCHES USED FOR THE FINISHED PRODUCTS WERE REVIEWED (OF-88643 CORRESPONDING TO THE BATCH 2106227; OF-109991 CORRESPONDING TO BATCH 2112080 AND OF-233810 CORRESPOND TO THE BATCH 2210194). THE RESULTS OF THESE BATCHES WERE CONFORM TO THE SPECIFICATIONS. ALL THE CONTROLS ARE COMPLIANT TO THE SPECIFICATIONS. NO NON-CONFORMITY WAS RECORDED ON THESE BATCHES. THE QUALITY OF THE BATCHES IS NOT QUESTIONED. IN THE IFU028_R02 IN2BONES QUANTUM TAR FROM 10/2022, IT IS MENTIONED IN THE PARAGRAPH 5 "COMPLICATIONS" THAT: "COMPLICATIONS MAY INCLUDE BUT ARE NOT LIMITED TO: [...], INFECTION, [...]". THEN, THE PACKAGING AND LABELLING INTEGRITY MUST BE CHECK BEFORE USE (PARAGRAPH 6.2 PERIOPERATIVE). THIS COULD PREVENT INFECTION IN CASE THE PRODUCT IS NO MORE STERILE. ACCORDING TO QUANTUM CER REV04, AN INFECTION CAN OCCUR FOR UP TO 4.6% OF TOTAL ANKLE REPLACEMENT. THIS IS THE FOURTH CASE OF INFECTION REPORTED AFTER A QUANTUM SURGERY THAT LED TO A REVISION SURGERY. THE INVESTIGATION SHOWS THAT: - NO NON-CONFORMITY WHICH MIGHT EXPLAIN THE ISSUE WERE RECORDED ON THE BATCH USED - GAMMA IRRADIANT WAS PERFORMED BY THE SUPPLIER WITHOUT ANY ISSUE - THE SAMPLE WAS DISCARDED - NO MORE INFORMATION WAS PROVIDED ABOUT THE SURGERY - THE SURGEON MENTIONED THAT THE INFECTION IS NOT RELATED TO THE IMPLANT - THIS TYPE OF ADVERSE EVENT (INFECTION) IS KNOWN AND DOCUMENTED IN THE IFU THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED.

    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: IT WAS REPORTED BY (B)(6) ON (B)(6) 2025 THAT "DR (B)(6) HAD TO DO A QUANTUM REVISION BECAUSE OF AN INFECTION. HE WROTE THE FOLLOWING: "UNFORTUNATELY, I HAD TO REMOVE MY LAST QUANTUM PROSTHESIS DUE TO A LOW-GRADE INFECTION. I AM PLANNING A RE-IMPLANTATION THIS MONTH. I MIGHT NEED THE TIBIAL FLAT CUT AND THE MANUAL INSTRUMENTS FOR THIS. WHEN WOULD THAT BE POSSIBLE? MAYBE WE SHOULD HAVE A QUICK PHONE CALL TOMORROW. I'M IN THE OPERATING ROOM AND IT SHOULD WORK OUT SOMEHOW". I CALLED HIM. HE REMOVED ALL COMPONENTS COMPLETLY (TIBIA 6, LONG, INSERT 6,6MM, TALAR 6, RIGHT SIDE). HIS IDEA IS TO DO A RE-IMPLANTATION END OF (B)(6) WITH THE MANUAL JIG INSTRUMENTS. HE WOULD LIKE TO RESECT BONE A FEW MM TO USE THE SAME IMPLANTS. OR TO USE THE FLAT CUT ON THE TALAR SIDE." THE CONMED FILE NAMED "BEANSTANDUNGSFORMULAR" FILLED BY THE COMPLAINANT DR (B)(6) INDICATES THAT THE FIRST IMPLANT DATE IS THE (B)(6) 2024 AND THE EXPLANTATION DATE IS THE (B)(6) 2024. ADDITIONAL INFORMATION ON (B)(6) 2025 REPORTED THAT "DR. (B)(6) DOESN'T THINK THAT THE LOW GRADE INFECT HAS SOMETHING TO DO WITH QUANTUM." SURGEON WAS SAYING ON (B)(6) 2025 THAT "HE WOULD LIKE TO RESECT BONE A FEW MM". 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
    1642405 QUANTUM® TOTAL ANKLE PROSTHESIS QUANTUM HSN IN2BONES SAS 2106227; 2112080; 2210194

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Other