BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BEARING

    MDR report key: 24766698 · Received April 2, 2026

    Report

    Report Number
    0001822565-2026-01086
    Event Type
    Injury
    Date Received
    April 2, 2026
    Report Date
    May 21, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: LITERATURE - WATANABE S, KAIBARA T, FEELEY BT, ZHANG AL, LANSDOWN DA, MA CB. (2025). SURVIVAL RATE AND OUTCOMES OF REVERSE TOTAL SHOULDER ARTHROPLASTY WITH A MINIMUM TEN-YEAR FOLLOW-UP USING A TRABECULAR METAL IMPLANT. BONE JT OPEN. 2025 OCT 2;6(10):1171-1178. DOI: 10.1302/2633-1462.610.BJO-2025-0147.R1. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A JOURNAL ARTICLE THAT A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISLOCATION APPROXIMATELY 2 WEEKS POST IMPLANTATION. THE PATIENT UNDERWENT A REVISION OF THE POLYETHYLENE LINER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70723 UNK BEARING PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1