BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR® COCR NECK

    MDR report key: 8196399 · Received December 26, 2018

    Report

    Report Number
    3010536692-2018-01563
    Event Type
    Injury
    Date Received
    December 26, 2018
    Date of Event
    October 25, 2017
    Report Date
    December 26, 2018
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO COCR NECK FRACTURE (LEFT). THE FOLLOWING COMPONENTS HAVE NO ALLEGED DEFICIENCY AND WERE NOT REVISED DURING THIS SURGERY: LINEAGE® ACETABULAR SHELL, 3645-0054, LOT # 141868, QTY. 1. LINEAGE® CERAMIC LINER, 7200-3252, LOT # 0611372412, QTY. 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036812 PROFEMUR® COCR NECK HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. PHAC-1254 1419971

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention