BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM® TOTAL ANKLE PROSTHESIS

    MDR report key: 23110147 · Received September 22, 2025

    Report

    Report Number
    3010470577-2023-07521
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    July 19, 2023
    Report Date
    September 22, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HSN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TALAR IMPLANT WAS NOT CORRECTLY INSERTED BY THE USER, AS REPORTED BY THE INITIAL COMPLAINT INITIATOR. ADDITIONAL INFORMATION COMMUNICATED BY C. GIL (IN2BONES USA, MARKETING) ON MARCH 28TH, 2024: "I WAS ABLE TO SPEAK WITH DR. (B)(6). PER THAT DISCUSSION THE PATIENT HAS YET NOT BEEN REVISED BY HIM, BUT HE DID INDICATE THAT THAT WAS THE LIKELY PATHWAY BASED ON HIS FINDINGS. OF NOTE, HE MENTIONED THAT THE PATIENT WAS LIKELY LOST TO FOLLOW-UP, AND HE IS UNSURE OF WHETHER OR NOT THEY WENT TO A DIFFERENT SURGEON OR IF THEY HAVE HAD THE REVISION COMPLETED ELSEWHERE. HE WAS NOT AT HIS OFFICE TO PROVIDE ADDITIONAL INFORMATION SURROUNDING THE ORIGINAL CASE DATE WHEN WE SPOKE. UNFORTUNATELY, THAT IS ALL THE INFORMATION THAT I CAN PROVIDE FOR NOW, BUT I HOPE IT HELPS. » AS REPORTED BY THE SURGEON AND COMMUNICATED BY THE COMPLAINT INITIATOR, THE NEED FOR REVISION IS RELATED TO AN UNSUITABLE INITIAL PLACEMENT OF THE TALAR COMPONENT (DURING THE CASE, THE SURGOEN " WENT MORE POSTERIOR THAN HE WANTED" WITH THE TALAR COMPONENT). THE CASE WAS PERFORMED MANUALLY AND THUS; THE FOLLOWING STEPS RECOMMENDED ON THE SURGICAL TECHNIQUE MANUAL "ST-DIG-QUANTUM-REUSABLE-EN-072023" WERE NOT CORRECTLY FOLLOWED BY THE USER: - "5. FINAL TALAR PREPARATION"; - "6. TRIALING" (TALUS TRIAL); - "8. IMPLANTATION" (TALAR IMPLANT).

    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: IN2BONES USA COMPLAINT (B)(4) - RECEIVED BY EMAIL ON JULY 24TH, 2023: "A SURGEON REACHED OUT TO IN2BONES REGARDING A POTENTIAL REVISION CASE. A SURGERY PERFORMED USING A MANUAL INSTRUMENT WAS PERFORMED APPROXIMATELY 10-MONTHS AGO. PATIENT REPORTED RESIDUAL PAIN AND THE SURGEON INDICATED THAT DURING THE CASE HE "WENT MORE POSTERIOR THAN HE WANTED" WITH THE TALAR COMPONENT TO "TRY AND MATCH IT WITH THE TIBIA." A DIAGNOSTIC CT WAS CAPTURED AND DR. (B)(6) INDICATED THAT HE PLANNED TO REVISE THE CHAMFERED TALAR COMPONENT TO A FLAT-CUT BUT WILL KEEP THE EXISTING TIBIAL COMPONENT." "PLEASE NOTE THAT THE REVISION HAS NOT OCCURRED YET. ALSO, BASED ON THE WAY THE INFORMATION WAS REPORTED, IT SEEMS THAT THE SURGEON BELIEVES THE CAUSE FOR THE NEED FOR REVISION WAS USER ERROR AS HE NOTED HE DID NOT PLACE THE IMPLANTS EXACTLY WHERE HE WANTED." A REVISION SURGERY MIGHT BE PERFORMED (TALAR COMPONENT ONLY). THIS REPORTABLE EVENT IS PART OF A REMEDITION RESULTING FROM A 483 LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170253 QUANTUM® TOTAL ANKLE PROSTHESIS QUANTUM HSN IN2BONES SAS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention