BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM TOTAL ANKLE/TOTAL TALUS REPLACEMENT

    MDR report key: 22441023 · Received July 8, 2025

    Report

    Report Number
    3014833750-2025-00010
    Event Type
    Injury
    Date Received
    July 8, 2025
    Report Date
    July 8, 2025
    Manufacturer
    RESTOR3D, INC.
    Product Code
    HSN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT HAD A PRIOR TOTAL ANKLE REPLACEMENT THAT FAILED WITH THE TALAR DOME COLLAPSING INTO THE SUBTALAR JOINT. IT WAS REVISED WITH A CUSTOM TOTAL ANKLE/TOTAL TALUS REPLACEMENT AS 520(B) CUSTOM PER DESIGN INPUTS BY, AND APPROVAL FROM, THE OPERATING PHYSICIAN. ACCORDING TO THE PHYSICIAN, THE PATIENT'S MEDIAL SOFT TISSUES COMPLETELY GAVE OUT, LEADING TO INSTABILITY AND VALGUS COLLAPSE. REVIEW OF PRODUCTION RECORDS REVEALS NO ABNORMALITY THAT MIGHT HAVE CONTRIBUTED TO ANY ADVERSE EVENT. FROM THE INFORMATION PROVIDED BY THE PHYSICIAN, THERE IS NO SUGGESTION THAT THE EVENT WAS DUE TO THE RESTOR3D IMPLANT, BUT RATHER DUE TO THE PATIENT'S CONDITION AND FAILURE OF THEIR SOFT TISSUES.

    Description of Event or Problem · 0

    THE PATIENT RECEIVED A TOTAL ANKLE-TOTAL TALUS REPLACEMENT AS A REVISION TO A FAILED TAR. THE PATIENT LATER PRESENTED WITH BONE LOSS AND VOIDS IN THE CALCANEUS REQUIRING REVISION TO AN ANKLE FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856561 CUSTOM TOTAL ANKLE/TOTAL TALUS REPLACEMENT TATTR HSN RESTOR3D, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention