BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SRS SHOULDER GLENOSPHERE

    MDR report key: 22393585 · Received July 2, 2025

    Report

    Report Number
    MW5172197
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    August 12, 2024
    Report Date
    June 30, 2025
    Manufacturer
    ZIMMER, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING AN ATRAUMATIC SHOULDER ROTATION THE GLENOSPHERE DISSOCIATED FROM THE BASE PLATE. THIS DID NOT INVOLVE EXTREME RANGE OF MOTION OR ANY SIGNIFICANT FORCE. THIS OCCURRED FOR THE 1ST TIME ON (B)(6) 2024 AND A 2ND TIME ON (B)(6) 2024. THERE WAS NO EVIDENCE OF INFECTION OR MALALIGNMENT OF ANY OF THE REMAINING PROSTHETIC PARTS. TO VERY EXPERIENCED SHOULDER ELBOW SURGEONS INSPECTED AN IMPLANTED THE GLENOSPHERE COMPONENTS ONTO THE WELL-FIXED GLENOID BASE PLATE AT THE TIME OF BOTH SURGICAL REOPERATIONS. LABORATORY EVALUATION CONFIRMED NO EVIDENCE OF INFECTION AND RADIOGRAPHS DEMONSTRATED NO MALALIGNMENT OF THE REMAINING PROXIMAL HUMERAL REPLACEMENT COMPONENTS. PT CODES: 1924, 2032. DEVICE CODES: 2907, 2960, 3026. REF REPORT: MW5172196.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176916 SRS SHOULDER GLENOSPHERE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER, INC. 110030777

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention