BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE BASEPLATE WITH TAPER ADAPTER

    MDR report key: 22954869 · Received September 3, 2025

    Report

    Report Number
    0001825034-2025-02775
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 12, 2025
    Report Date
    January 21, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304532465
    PMA / PMN Number
    K193373
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: A1; B4; B5; D2; D9; G1; G3; G6; H1; H2; H3; H6. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE TAPER ADAPTOR SHOWED SIGNS OF USE AS WELL AS WEAR AND TEAR. THERE ARE SCRATCHES AND GOUGES ACROSS THE BODY OF THE DEVICE AS WELL AS SCRATCHES AND GOUGES ON THE TAPER OF THE TAPER ADAPTOR. A DEPTH GAUGE WAS USED TO MEASURE THE HEIGHT OF THE TAPER TO CONFIRM THE DEVICE WAS CONFORMING TO THE PRINT SPECIFICATIONS. THE ASSOCIATED GLENOSPHERE, BEARING, AND TRAY WERE ALSO RETURNED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY WITH DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. OPERATIVE NOTES WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 110031425; LOT# 65592671. ITEM# 110031411; LOT# 66272761. ITEM# 115310; LOT# J7848673. ITEM# 113611; LOT# 66418140. G2: FOREIGN - EVENT OCCURRED IN JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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

    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 IMPLANTATION OF A COMPREHENSIVE REVERSE SHOULDER APPROXIMATELY SIX (6) MONTHS AGO. SUBSEQUENTLY, IT WAS DISCOVERED DURING THE PATIENT'S REGULAR CHECKUP THREE (3) MONTHS POST-IMPLANTATION THAT THE BASEPLATE AND TAPER ADAPTER DISASSOCIATED. THE PATIENT LATER UNDERWENT A REVISION APPROXIMATELY FIVE (5) MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397738 COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE BASEPLATE WITH TAPER ADAPTER SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 66535795 00880304532465

    Patients

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