BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR® NECK A/R 8DG SHORT COBALT CHROME

    MDR report key: 9555125 · Received January 6, 2020

    Report

    Report Number
    3010536692-2020-00021
    Event Type
    Injury
    Date Received
    January 6, 2020
    Report Date
    May 21, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    UDI-DI
    M684PHAC12321
    PMA / PMN Number
    K091423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION ON 03/16/2020: ALLEGEDLY, THE PATIENT WAS REVISED DUE TO CORROSION OF COCR COMPONENTS. UPDATED EVENT CODES.

    Description of Event or Problem · 0

    ALLEGEDLY PATIENT WAS REVISED DUE TO UNKNOWN REASONS. LEFT HIP. UPDATED INFORMATION ON 03/16/2020: ALLEGEDLY, THE PATIENT WAS REVISED DUE TO CORROSION OF COCR COMPONENTS.

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT WAS REVISED DUE TO UNKNOWN REASONS. LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14631 PROFEMUR® NECK A/R 8DG SHORT COBALT CHROME HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. PHAC1232 1702505 M684PHAC12321

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention