BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® NITRX? FEM

    MDR report key: 21555177 · Received March 8, 2025

    Report

    Report Number
    3010536692-2025-00047
    Event Type
    Injury
    Date Received
    March 8, 2025
    Report Date
    March 7, 2025
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MPO WAS MADE AWARE OF REVISIONS FOR LOOSENING FROM A GERMAN REGISTRY REPORT (EPRD). SPECIFIC INFORMATION FOR EACH EVENT IS NOT AVAILABLE. LOOSENING IS A KNOWN RISK OF TOTAL KNEE ARTHROPLASTY. TRENDING DOES NOT REVEAL AN INCREASE IN RISK LEVEL FOR THIS PART FAMILY. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO PERFORM ANY FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    ALLEGEDLY, EPRD REPORTED 11 NEW COMPLICATIONS FOR EVOLUTION® NITRX FEMORAL KNEE REVISION (3 INFECTIONS, 2 LOOSENING, 3 OTHER, 1 UNKNOWN, 1 DISLOCATION, 1 FRACTURE). NO FURTHER INFORMATION WAS REPORTED. THIS INCIDENT IS CAPTURING 3 INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233363 EVOLUTION® NITRX? FEM HIP COMPONENT JWH MICROPORT ORTHOPEDICS INC. EFSANXXX NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention