BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW

    MDR report key: 25068497 · Received May 4, 2026

    Report

    Report Number
    0001825034-2026-01187
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    December 12, 2022
    Report Date
    May 1, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304677173
    PMA / PMN Number
    K130390
    Removal / Correction 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). D10: ITEM# 180551; LOT# 609770. ITEM# 180556; LOT# 651640. ITEM# 180555; LOT# 030310. ITEM# 110027734; LOT# 026860. ITEM# 110031418; LOT# 64790153. ITEM# 110031402; LOT# 65255202. ITEM# 115310; LOT# J7238894. ITEM# 110031378; LOT# 026870. ITEM# 113610; LOT# 65319641. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE TWO MOST INFERIOR GLENOID BASEPLATE FIXATION SCREWS ARE FRACTURED. THERE IS SIRVEAUX GRADE 1/2 SCAPULAR NOTCHING. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT WAS CONFIRMED. 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 BY THE PMI GROUP THAT A PATIENT UNDERWENT A SHOULDER ARTHROPLASTY THREE (3) YEARS AND SIX (6) MONTHS AGO TO RECEIVE A VRS SHOULDER. SUBSEQUENTLY, THE PATIENT WAS REVISED ON SIX (6) MONTHS POST-IMPLANTATION DUE TO SCREW FRACTURE AND RECEIVED A COMPETITOR BASEPLATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10076 COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 612370 00880304677173

    Patients

    Seq Age Sex Outcome Treatment
    1