BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TAPER

    MDR report key: 24498755 · Received March 3, 2026

    Report

    Report Number
    0001825034-2026-00490
    Event Type
    Injury
    Date Received
    March 3, 2026
    Report Date
    March 3, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: UNK BASEPLATE CAT# UNK LOT# UNK. UNK GLENOSPHERE CAT# UNK LOT# UNK. G2: FOREIGN - EVENT OCCURRED IN SOUTH KOREA. G2: LITERATURE - CLINICAL OUTCOME OF REVERSE TOTAL SHOULDER ARTHROPLASTY (COMPREHENSIVE SYSTEM) AFTER FAILED ROTATOR CUFF REPAIR WITH A MEDIUM-TERM FOLLOW-UP: COMPARISON WITH REVERSE TOTAL SHOULDER ARTHROPLASTY FOR MASSIVE ROTATOR CUFF TEAR WITHOUT OSTEOARTHRITIS. KIM, JI UN; YOON, JI YOUNG; JEON, YOUNG DAE; CHO, HYUNG KI; JEONG, HYEON JANG; OH, JOO HAN JSES INTERNATIONAL, VOLUME 9, ISSUE 6, 2081 - 2086 DOI: 10.1016/J.JSEINT.2025.06.012. 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 ONE PATIENT WHO UNDERWENT REVERSE TOTAL SHOULDER ARTHROPLASTY FOR CUFF TEAR ARTHROPATHY DEVELOPED SCAPULAR NOTCHING THAT ULTIMATELY REQUIRED REVISION SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555047 UNK TAPER PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H