BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM TOTAL ANKLE REPLACEMENT

    MDR report key: 24245134 · Received February 3, 2026

    Report

    Report Number
    3010470577-2025-01015
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    October 1, 2025
    Report Date
    November 28, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HSN
    PMA / PMN Number
    K191380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IN2BONES SAS RECEIVED FROM (B)(6) HOSPITAL A COMPLAINT DESCRIBING FOLLOWING EVENT: "DURING A CASE, AS THE IMPLANT WAS ABOUT TO BE INSERTED (M50 SC135, LOT 2204203), IT WAS DISCOVERED THAT THE IMPLANT HAD EXPIRED ON (B)(6) 2025. THERE WAS NO ALTERNATIVE IMPLANT. THE SURGEON DETERMINED THAT CHANGING SIZE AT THAT STAGE WOULD COMPROMISE THE PROCEDURE AND, GIVEN IT WAS ONLY ONE MONTH POST EXPIRY, MADE THE CLINICAL DECISION TO IMPLANT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305065 QUANTUM TOTAL ANKLE REPLACEMENT QUANTUM TALAR IMPLANT STANDARD RIGHT SIZE 5 HSN IN2BONES SAS M50 SC135 2003088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown