BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANA FEMORAL LIFT

    MDR report key: 3842666 · Received May 27, 2014

    Report

    Report Number
    3842666
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    March 15, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FEMORAL LIFTER BROKE DURING ANTERIOR TOTAL HIP REPLACEMENT. THE BOLT SNAPPED INSIDE THE HOOK POST WHICH RESULTED IN A SMALL FEMUR FRACTURE FOR THE PATIENT. SURGEON AWARE. NO FURTHER MEDICAL INTERVENTION/TREATMENT REQUIRED FOR FEMUR FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310388 HANA FEMORAL LIFT TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA MIZUHO ORTHOPEDIC SYSTEMS, INC 6850 *
    310389 HANA SUPPORT HOOK TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA MIZUHO ORTHOPEDIC SYSTEMS, INC 6850 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR FRACTURE TABLE