BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19615999 · Received June 26, 2024

    Report

    Report Number
    3010536692-2024-00376
    Event Type
    Injury
    Date Received
    June 26, 2024
    Report Date
    August 14, 2024
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    UDI-DI
    M684EIS6S10L1
    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: L. GENDER: M. NON REVISED PRODUCTS: PRODUCT ID: EFSRN5PL EVOLUTION® MP FEM CS/CR NON-POROUS SIZE 5 PRIMARY LEFT/ LOT. NO.: 1973342/ QTY: 1. PRODUCT ID: ETPKN6SL EVOLUTION® MP TIBIAL BASE KEELED NON-POROUS SIZE 6 STANDARD LEFT/ LOT. NO.: 197723/ QTY: 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640229 EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 10MM LEFT KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. EIS6S10L 1972241 M684EIS6S10L1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention