BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERTURETI KNEE RESURFACING SYSTEM

    MDR report key: 23235276 · Received October 7, 2025

    Report

    Report Number
    3027737826-2025-00002
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 6, 2025
    Manufacturer
    OVERTURE ORTHOPAEDICS
    Product Code
    HSX
    PMA / PMN Number
    K221292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025 WE WERE NOTIFIED OF A REVISION SURGERY INVOLVING EXPLANTATION OF OUR TIBIAL AND FEMORAL IMPLANTS, INITIALLY IMPLANTED ON (B)(6) 2024. THE REVISION WAS PERFORMED ON (B)(6) 2025, BECAUSE THE TIBIAL COMPONENT SEEMED TO BE COLLAPSED BASED ON THE XRAY, WHICH LED TO REMOVAL OF BOTH TIBIAL AND FEMORAL IMPLANTS. OVERTURE SYSTEM WAS REMOVED AND ZB TOTAL KNEE WAS PERFORMED. NO ISSUES WERE NOTED FOR THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2653308 OVERTURETI KNEE RESURFACING SYSTEM KNEE JOINT FEMOROTIBIAL METAL/POLYMER NON-CONSTRAINED CEMENTED PROSTHESIS, HSX OVERTURE ORTHOPAEDICS PKG-90-OVR-300017 LSP0026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention