BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® MP? CS INSERT SIZE 3+ 17MM RIGHT

    MDR report key: 20906899 · Received December 11, 2024

    Report

    Report Number
    3010536692-2024-00497
    Event Type
    Injury
    Date Received
    December 11, 2024
    Report Date
    December 5, 2025
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    UDI-DI
    M684EIS3P17R1
    PMA / PMN Number
    K093552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 HAD A NON-MPO TKR REQUIRING REVISION DUE TO INFECTION. A SPACER WAS PLACED ON (B)(6) 2023, WITH EVOLUTION REVISION KNEE IMPLANTED SECOND STAGE ON (B)(6) 2023. THE PATIENT DEVELOPED A FUNGAL INFECTION, REQUIRING ANOTHER REVISION ON (B)(6) 2024. DUE TO DEBRIDEMENT THAT WAS DONE DUE TO THE INFECTION THE SURGEON DECIDED THAT A THICKER INSERT WOULD BE MORE SUITABLE. REVISED WITH A 20MM INSERT. PRODUCTS IMPLANTED DURING REVISION SURGERY: PRODUCT: ETRKN3SR "EVOLUTION® REV TIB BASE NONPOR", LOT: 1814397, QTY: 1. PRODUCT: ETRKMK36 "EVOLUTION® REV TIB MOD KEEL", LOT: 1984317, QTY: 1. PRODUCT: ESP18100 "EVOLUTION® CANAL FILL STEM EXT", LOT: 1807034, QTY: 1. PRODUCT: EFPAN404, "EVOLUTION® REVISION POSTERIOR" LOT: 1754543, QTY: 1. PRODUCT: ESRF0425, "EVOLUTION® FEM OFFSET ADAPTER", LOT: 1755164, QTY: 1. PRODUCT: ESP17100, "EVOLUTION® CANAL FILL STEM EXT", LOT: 1788874, QTY: 1. PRODUCT: EFSRN4RR "EVOLUTION® FEMORAL STEMMED CS" LOT: 1926304, QTY: 1. AUSTRALIA - C24-560.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2428430 EVOLUTION® MP? CS INSERT SIZE 3+ 17MM RIGHT KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. EIS3P17R 10012286601792540 M684EIS3P17R1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention