BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERTURETI KNEE RESURFACING SYSTEM

    MDR report key: 23555600 · Received November 14, 2025

    Report

    Report Number
    3027737826-2025-00003
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 12, 2025
    Manufacturer
    OVERTURE ORTHOPAEDICS
    Product Code
    HSX
    UDI-DI
    00810129550207
    PMA / PMN Number
    K221292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON OCTOBER 14, 2025, OVERTURE WAS NOTIFIED OF A REVISION SURGERY INVOLVING THE REMOVAL OF TIBIAL 20MM AND FEMORAL OBLONG 22.5X40MM IMPLANTS, INITIALLY IMPLANTED ON (B)(6) 2024. THE REVISION WAS PERFORMED TO CONVERT THE OVERTURE SYSTEM TO A TOTAL KNEE REPLACEMENT AFTER THE PATIENT REPORTED KNEE PAIN. THE SURGEON STATED THAT THE IMPLANTS WERE WELL FIXED, BUT THERE WERE POLY FRAGMENTS IN THE KNEE. THE TIBIAL POLYETHYLENE ARTICULATION SURFACE WAS WORN AND PITTED. THE FEMORAL COMPONENT APPEARED UNREMARKABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2601123 OVERTURETI KNEE RESURFACING SYSTEM KNEE JOINT FEMOROTIBIAL METAL/POLYMER NON-CONSTRAINED CEMENTED PROSTHESIS HSX OVERTURE ORTHOPAEDICS PKG-90-OVR-300020 LSP0027 00810129550207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention