BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERTURETI KNEE RESURFACING SYSTEM

    MDR report key: 22523541 · Received July 16, 2025

    Report

    Report Number
    3027737826-2025-00001
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 15, 2025
    Manufacturer
    OVERTURE ORTHOPAEDICS
    Product Code
    HSX
    UDI-DI
    00810129550214
    PMA / PMN Number
    K221292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON 06/23/2025 OVERTURE WAS NOTIFIED BY A SALES REPRESENTATIVE, THAT A PATIENT REQUIRED REVISION DUE TO TIBIAL IMPLANT LOOSENING. ON (B)(6) 2025 THE OVERTURE IMPLANT WAS REMOVED AND REPLACED WITH A UNICOMPARTMENTAL KNEE ARTHROPLASTY DEVICE. THE OVERTURE IMPLANT WAS IMPLANTED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554468 OVERTURETI KNEE RESURFACING SYSTEM KNEE JOINT FEMOROTIBIAL METAL/POLYMER NON-CONSTRAINED CEMENTED PROSTHESIS HSX OVERTURE ORTHOPAEDICS LSP0028 00810129550214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention