BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HUMERAL STEM

    MDR report key: 24639878 · Received March 19, 2026

    Report

    Report Number
    0001822565-2026-00852
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    February 25, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) VAUCLIN, CAMERON ET AL (2025). CLINICAL OUTCOMES OF MODULAR SEGMENTAL MEGAPROSTHESIS FOR REVISION SHOULDER ARTHROPLASTY WITH SEVERE PROXIMAL HUMERUS BONE LOSS AT A MINIMUM TWO-YEAR FOLLOW-UP. JSES INTERNATIONAL, VOLUME 10, ISSUE 1, 101381 HTTPS://DOI.ORG/10.1016/J.JSEINT.2025.09.003. 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 IN A JOURNAL ARTICLE THAT A PATIENT UNDERWENT A SHOULDER REVISION PROCEDURE APPROXIMATELY 8 MONTHS POST IMPLANTATION DUE TO LOOSENING OF THE HUMERAL STEM. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61681 UNK HUMERAL STEM PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown Required Intervention| H