BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MD HYBRID GLENOID BASE 4MM

    MDR report key: 24628297 · Received March 18, 2026

    Report

    Report Number
    0001825034-2026-00558
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 11, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304462489
    PMA / PMN Number
    K193038
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 113053; LOT# 798910. ITEM# 113631; LOT# 647540. ITEM# 118001; LOT# 959640. ITEM# PT-113950; LOT# 280950. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY SIX (6) YEARS POST-IMPLANTATION DUE TO LOOSENING OF THE GLENOID COMPONENT. IT WAS NOTED THAT THE PATIENT ALSO HAD POLY WEAR OF THE GLENOID COMPONENT AND OSTEOLYSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691055 MD HYBRID GLENOID BASE 4MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED MBF ZIMMER BIOMET, INC. NI 711170 00880304462489

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE NARRATIVE IN H11.