BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HUMERAL TRAY TAPER

    MDR report key: 21950151 · Received May 2, 2025

    Report

    Report Number
    0001825034-2025-01310
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    April 10, 2025
    Report Date
    May 13, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. ATTEMPTS HAVE BEEN MADE TO GATHER PRODUCT ID INFORMATION AND NO FURTHER INFO IS AVAILABLE VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE TAPER FRACTURED. MEDICAL RECORDS WERE NOT PROVIDED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS CONFIRMED AS A PICTURE WAS PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. D10: ITEM# 211219; LOT# 66485982. ITEM# 110031399; LOT# 67121712. ITEM# 110031429; LOT# 65854049. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS NOT RETURNED BY THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY THREE (3) WEEKS AGO DUE TO THE HUMERAL TRAY TAPER FRACTURING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195516 UNK HUMERAL TRAY TAPER SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE NARRATIVE IN H11