BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HUMERAL STEM

    MDR report key: 24686647 · Received March 25, 2026

    Report

    Report Number
    0001822565-2026-00937
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    February 25, 2026
    Report Date
    March 25, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    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): H6: PROPOSED CODE: MECHANICAL (G04)- STEM. 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

    A JOURNAL ARTICLE WAS OBTAINED ON 25-FEB-2026 THAT REPORTED A RETROSPECTIVE STUDY FROM THE USA. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE FUNCTIONAL OUTCOMES, PAIN, AND SURVIVORSHIP OF MODULAR SEGMENTAL MEGAPROSTHESIS UTILIZED FOR REVISION, REVERSE TOTAL SHOULDER ARTHROPLASTY FOLLOWING FAILED SHOULDER ARTHROPLASTY IN THE SETTING OF SEVERE PROXIMAL HUMERAL BONE LOSS. BETWEEN 2014 AND 2022, REVIEWED A TOTAL OF 28 PATIENTS WHO UNDERWENT REVISION SHOULDER ARTHROPLASTY RECONSTRUCTION USING A COMPREHENSIVE SEGMENTAL REVISION SYSTEM AT LOUISIANA STATE UNIVERSITY HEALTH SHREVEPORT. THE STUDY POPULATION HAD A MEAN AGE OF 76 YEARS AT TIME OF SURGERY (RANGE, 60-91 YEARS); (7 MALES/21 FEMALES). FOLLOW-UP WAS CONDUCTED AT 6-WEEK, 12-WEEK, 6-MONTH, 1-YEAR, AND 2-YEAR INTERVALS, WITH A MEAN LENGTH OF FOLLOW-UP FOR 2.8 YEARS (RANGE, 2.0-3.5 YEARS). THE LITERATURE REPORTED ONE PATIENT REQUIRED AN ORIF ONE MONTH POST-OPERATIVE DUE TO A FRACTURE DISTAL TO THE TIP OF THE STEM. LATER, UNDERWENT A REVISION OF THE CEMENTED HUMERAL COMPONENT DUE TO A PERIPROSTHETIC REFRACTURE AND A TOTAL HUMERUS REPLACEMENT WAS PERFORMED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746370 UNKNOWN HUMERAL STEM PROSTHESIS, REVERSE SHOULDER PHX ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Unknown Required Intervention| H SEE H11 NARRATIVE.