BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RTSA

    MDR report key: 21608671 · Received March 14, 2025

    Report

    Report Number
    3014833750-2025-00003
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    January 27, 2025
    Report Date
    March 14, 2025
    Manufacturer
    RESTOR3D, INC.
    Product Code
    PHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ULTIMATELY, THE CAUSE OF GLENOSPHERE DISASSOCIATION IS UNKNOWN. THERE ARE NUMEROUS POTENTIAL CAUSES RANGING FROM IMPROPER ASSEMBLY, FAILURE TO ENSURE SURROUNDING COMPONENT SUCH AS SCREWS ARE FULLY SEATED, OR THE MORE TAPER SURFACE NOT BEING CLEAN PRIOR TO ENGAGEMENT. REVIEW OF LHR, DHR, AND INSPECTION RECORDS SHOW THE PART WAS DESIGNED, MANUFACTURED, AND SHIPPED AS INTENDED. TAPER ENGAGEMENT IS TESTED AND VERIFIED. THE PATIENT RECEIVED A REPLACEMENT GLENOSPHERE ON (B)(6) 2025 AS PART OF A SUCCESSFUL REVISION SURGERY, AND THERE HAS BEEN NO FURTHER MALFUNCTION REPORTED.

    Description of Event or Problem · 0

    THE GLENOSPHERE WAS FOUND DISASSOCIATED APPROXIMATELY 2 WEEKS POST-OP ON FOLLOW-UP X-RAY FILMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399100 RTSA REVERSE TOTAL SHOULDER ARTHROPLASTY PHX RESTOR3D, INC. E-485

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention