BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERTURETI KNEE RESURFACING SYSTEM

    MDR report key: 24338139 · Received February 13, 2026

    Report

    Report Number
    3027737826-2026-00002
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    January 21, 2026
    Report Date
    February 13, 2026
    Manufacturer
    OVERTURE ORTHOPAEDICS
    Product Code
    HSX
    UDI-DI
    00810129550207
    PMA / PMN Number
    K221292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. AN INVESTIGATION WAS CONDUCTED BASED ON COMMUNICATION PROVIDED BY THE SURGEON WHO IMPLANTED THE DEVICE AND PERFORMED THE REVISION AND ON PHOTOGRAPHS PROVIDED BY THE SURGEON. IT IS NOT CLEAR FROM THE INFORMATION PROVIDED WHY THIS IMPLANT SEEMS TO HAVE WORN MORE THAN OTHER IMPLANTS OF THE SAME DESIGN. NO DISCREPANCIES WERE NOTED IN THE MANUFACTURING HISTORY, AND NO DEFECTS CAN BE CONFIRMED FROM THE INFORMATION PROVIDED. THE ROOT CAUSE CANNOT BE DEFINITIVELY IDENTIFIED.

    Description of Event or Problem · 0

    A BIPOLAR OVERTURE IMPLANT WAS REVISED TO A UKA ON (B)(6) 2026. REVISION WAS INDICATED BECAUSE OF PERSISTENT SWELLING. INSPECTION OF THE WELL-FIXED TIBIAL COMPONENT DEMONSTRATED EVIDENCE OF SIGNIFICANT POLYETHYLENE WEAR ON THE MEDIAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560558 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