BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 10MM RIGH

    MDR report key: 22178252 · Received June 10, 2025

    Report

    Report Number
    3010536692-2025-00282
    Event Type
    Injury
    Date Received
    June 10, 2025
    Report Date
    July 31, 2025
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    UDI-DI
    M684EIS6S10R1
    PMA / PMN Number
    K093552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: R GENDER: M NON REVISED PRODUCTS: PRODUCT ID: EFSRN6PR EVOLUTION® MP FEM CS/CR NON-POROUS SIZE 6 PRIMARY RIGHT/ LOT NO: 1984097/ QTY: (B)(4). PRODUCT ID: ETPKN6PR EVOLUTION® MP TIBIAL BASE KEELED NON-POROUS SIZE 6 PLUS RIGHT/ LOT NO.: 1989138/ QTY: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551152 EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 10MM RIGH KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. EIS6S10R 1969295 M684EIS6S10R1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention