BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® MP CS INSERT SIZE 3 STANDARD 10MM

    MDR report key: 19986081 · Received August 14, 2024

    Report

    Report Number
    3010536692-2024-00425
    Event Type
    Injury
    Date Received
    August 14, 2024
    Report Date
    September 5, 2025
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 0

    ALLEGEDLY, OPERATED IN FRANCE WITH TKA EVOLUTION CS NR 3, TIBIA 3 STD, INSERT 10 MM, PATELLA 29 MM - MICROPORT ORTHOPEDICS INC. NO FULL ORIGINAL DOCUMENTATION IS ACCESSIBLE FOR ME. AFTER OPERATION AND ACTUALLY DISCOMFORT, MAINLY WHEN BEARING WEIGHT, "IT FEELS LIKE IT'S JUMPING" IN THE KNEE. CLINICALLY UNSTABLE IN THE FRONTAL PLANE. ON X-RAY NO LOOSENING, PROPER GEOMETRY OF IMPLANT AND KNEE AXIS. QUESTION - ACCESSIBILITY OF TIBIAL INSERT IN POLAND WHEN PLANNING EXCHANGE FROM INSERT 10 MT 12- OR 14-MM HEIGHT. OTHER PRODUCT NOT RELATED WITH THE FAILURE: PRODUCT: EFSRN3PX EVOLUTION® MP FEM CS/CR NON-POR SIZE 3 PRIMARY, LOT: N/I, QTY: 1 PRODUCT: ETPKN3SX EVOLUTION® MP TIB KEELED NONPOR SIZE 3 STANDARDS, LOT: N/I, QTY: 1 PRODUCT: KPONTP29 ADVANCE® ONLAY ALL-POLY PATELLA TRI-PEG, LOT: N/I, QTY: 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2362674 EVOLUTION® MP CS INSERT SIZE 3 STANDARD 10MM KNEE COMPONENT JWH MICROPORT ORTHOPEDICS INC. EIS3S10X N/I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention