BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIS

    MDR report key: 17564130 · Received August 17, 2023

    Report

    Report Number
    17564130
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    July 12, 2023
    Report Date
    July 20, 2023
    Manufacturer
    DEPUY SYNTHES, INC.
    Product Code
    MEH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "SURGEON PLACE THE HEAD ONTO THE STEM AND BANGED IT IN PLACE. WHEN HE CHECKED TO SEE IF IT WAS SECURE, THE STEM CAME OUT. SURGEON TOOK X-RAYS TO CONFIRM FEMUR WAS NOT FRACTURED. IMPLANTS WERE SEQUESTERED AND REMOVED FROM THE ROOM. A DIFFERENT SIZE IMPLANT WAS USED TO COMPLETE THE SURGERY. THE REMAINDER OF THE PROCEDURE RESUMED WITHOUT INCIDENT. ITEMS GIVEN TO SUPPLY CHAIN MANAGEMENT (SCM). PER THE REP, SHE DOES NOT FEEL THERE WAS ANY ISSUE WITH THE IMPLANT BUT THE ISSUE WAS WITH THE SIZE OF THE BROOCH USED TO CREATE CAVITY FOR STEM IMPLANTATION. BECAUSE THE STEM CAME OUT, ANOTHER SIZE BROOCH WAS USED, AND THE IMPLANTATION OF THE STEM WAS SUCCESSFUL. THIS ITEM DID NOT NEED TO SEQUESTERED, BECAUSE IT WASN'T DEFECTIVE. NO FOLLOW UP NEEDED." MANUFACTURER RESPONSE FOR FEMORAL STEM AND HEAD IMPLANTS, DEPUY SYNTHES (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793355 ACTIS PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS MEH DEPUY SYNTHES, INC. 1010-12-070 3994279

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA Unknown