BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLIANCE GLENOID

    MDR report key: 25017744 · Received April 28, 2026

    Report

    Report Number
    0001822565-2026-01410
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K193180
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D6A: UNKNOWN DATE IN 2022. D10: ITEM# SAGP0002; LOT# UNKNOWN, ITEM# 118001; LOT# UNKNOWN, ITEM# SBGL7010; LOT# UNKNOWN, ITEM# 113075; LOT# UNKNOWN, ITEM# UNK STEM; LOT# UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED. 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 REVISION APPROXIMATELY FOUR (4) YEARS POST-IMPLANTATION DUE TO THE HUMERAL HEAD WEARING THROUGH THE GLENOID, RESULTING IN A HOLE IN THE GLENOID. HUMERAL HEAD AND GLENOID WERE REMOVED AND IT IS NOTED THE PATIENT MIGHT NEED A VRS IN THE FUTURE. IT WAS ALSO NOTED THAT THE PATIENT HAD A CYST VISIBLE ON THE GT SCAN BEHIND THE GLENOID, BUT IT IS UNKNOWN IF THAT CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54591 ALLIANCE GLENOID PROSTHESIS, SHOULDER, SEMI-CONSTRAINED KWS ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R SEE NARRATIVE IN H11.