BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE TOTAL SHOULDER ARTHROPLASTY

    MDR report key: 20481888 · Received October 18, 2024

    Report

    Report Number
    3014833750-2024-00003
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Report Date
    October 17, 2024
    Manufacturer
    RESTOR3D, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SHOWS THAT THE IMPLANT DESIGN WAS SEGMENTED AND DESIGNED AS INTENDED PER THE PHYSICIANS'S REQUEST THE DESIGN WAS APPROVED BY THE PHYSICIAN. THE DEVICE WAS REVIEWED FOR MECHANICAL STRENGTH AND PASSED THE REQUIREMENTS. UNRELATED TO THIS FAILURE, RESTOR 3D HAS SINCE INCREASED THE SOLID CORE DIAMETER ON THE CENTRAL POST FOR ADDITIONAL MECHANICAL STRENGTH.

    Description of Event or Problem · 0

    GLENOID BASEPLATE EXPERIENCED A FRACTURE AT THE POST FOR CENTRAL FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244002 REVERSE TOTAL SHOULDER ARTHROPLASTY PHX RESTOR3D, INC. 20230308-DMP-E-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention