BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL TALUS

    MDR report key: 22535464 · Received July 17, 2025

    Report

    Report Number
    3014833750-2025-00011
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    June 17, 2025
    Report Date
    July 17, 2025
    Manufacturer
    RESTOR3D, INC.
    Product Code
    QNN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED TO THE MANUFACTURER BY THE PHYSICIAN TO ELUCIDATE THE CAUSE OF THE ADVERSE EVENT. REVIEW OF PRODUCTION RECORDS REVEALS NO ABNORMALITIES RELATING TO THE DESIGN OR THE MANUFACTURE OF THE IMPLANT WERE IDENTIFIED. UPON REVIEW OF THE CASE DOCUMENTATION FOR THE IMPLANT IN QUESTION, THE ONLY INDICATION FOR THE ORIGINAL OPERATION THAT WAS PROVIDED TO THE MANUFACTURER WAS AVN OF THE TALUS. IT IS UNCLEAR WHETHER THE SUBJECT ARTHRITIS WAS PRESENT BEFORE THE INITIAL SURGERY, AND NO CONFIRMATION OF THIS WAS PROVIDED BY THE OPERATING PHYSICIAN.

    Description of Event or Problem · 0

    PATIENT REPORTED PAIN AROUND AN IMPLANTED TOTAL TALUS REPLACEMENT, AND SURGEON STATED THAT THE PATIENT HAS ARTHRITIS OF THE ANKLE AND SUBTALAR JOINT. SURGEON REQUESTED REVISION IMPLANT FOR THE TOTAL TALUS REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671971 TOTAL TALUS TOTAL TALUS REPLACEMENT QNN RESTOR3D, INC. LT_XC1P5-100 20220529-DMP-C01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention