BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION®MP TIB KEELED NONPOR SIZE 7 STANDARD LEF

    MDR report key: 15743933 · Received November 7, 2022

    Report

    Report Number
    3010536692-2022-00407
    Event Type
    Injury
    Date Received
    November 7, 2022
    Report Date
    December 21, 2022
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    UDI-DI
    M684ETPKN7SL1
    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. REVISION NJR NUMBER: 7. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. PRODUCTS NO REVISED: PRODUCT ID: EFSRN7PL, LOT: 1827636, QTY: 1. PRODUCT ID: EIS7S12L, LOT: 1786535, QTY: 1. PRODUCT ID: KPONTP38, LOT: 1823561, QTY: 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2838291 EVOLUTION®MP TIB KEELED NONPOR SIZE 7 STANDARD LEF KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. ETPKN7SL 1824380 M684ETPKN7SL1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention