BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL TALUS

    MDR report key: 21287040 · Received January 31, 2025

    Report

    Report Number
    3014833750-2025-00001
    Event Type
    Injury
    Date Received
    January 31, 2025
    Report Date
    January 31, 2025
    Manufacturer
    RESTOR3D, INC.
    Product Code
    QNN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPLANT WAS DESIGNED AS INTENDED AS IT PASSED ALL REQUIREMENTS FOR INSPECTION IN DIMENSIONS AND POLISHING. RESTOR3D HAD PROVIDED SMALLER SIZE IMPLANTS THAN THE ONE IMPLANTED FOR INTRAOPERATIVE FLEXIBILITY; HOWEVER, IT WAS UP TO THE PRIMARY SURGEON TO DECIDE THE BEST IMPLANT FIT FOR THE PATIENT. WHILE IMPLANT BEING OVERSIZED COULD BE A POTENTIAL CAUSE FOR PAIN AND COMPLICATIONS, ADDITIONAL CLINICAL INFORMATION WOULD BE NECESSARY TO FULLY UNDERSTAND THE SYMPTOMS DEVELOPED IN THE LONG TERM.

    Description of Event or Problem · 0

    THE PATIENT BEGAIN EXPERIENCING PAIN AFTER INITIALLY RECOVERING WELL FROM RECEIVING A TOTAL TALUS REPLACEMENT. SOME COLLEAGUES OF THE REVISING PHYSICIAN THOUGHT THE IMPLANT LOOKED OVERSIZED, BUT THE REVISING PHYSICIAN IS NOT CONVINCED THIS IS THE SOLE CAUSE OF THE PATIENT'S SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2176864 TOTAL TALUS TOTAL TALUS REPLACEMENT, FREE-FLOATING QNN RESTOR3D, INC. 20200130-DMP-C-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention