BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERTURETI KNEE RESURFACING SYSTEM - FEMORAL IMPLANT

    MDR report key: 19533479 · Received June 13, 2024

    Report

    Report Number
    3027737826-2024-00001
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 13, 2024
    Manufacturer
    OVERTURE ORTHOPAEDICS
    Product Code
    HSX
    UDI-DI
    00810129550092
    PMA / PMN Number
    K221292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024 OVERTURE WAS INFORMED THAT A PATIENT EXPERIENCED ACUTE INFECTION OF THE SURGICAL SITE AND A OVERTURETI REMOVAL TRAY KIT WAS REQUESTED. THE OVERTURETI KNEE RESURFACING SYSTEM -FEMORAL IMPLANT WAS IMPLANTED ON (B)(6) 2024, AND REMOVAL OF IMPLANT WAS COMPLETED ON (B)(6) 2024. ON MAY 28, 2024, FURTHER INFORMATION WAS PROVIDED INDICATING THAT DURING THE REMOVAL THE INFECTION AREA WAS CLEANED, AND PATIENT IS DOING WELL WITH HIGH WHITE BLOOD CELL COUNT CONFIRMED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372619 OVERTURETI KNEE RESURFACING SYSTEM - FEMORAL IMPLANT KNEE JOINT FEMOROTIBIAL METAL/POLYMER NON-CONSTRAINED CEMENTED PROSTHESIS HSX OVERTURE ORTHOPAEDICS LSP0022 00810129550092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention