BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPR RVS GLENO 2-PRNG INS/IMP

    MDR report key: 23945748 · Received January 2, 2026

    Report

    Report Number
    0001825034-2026-00008
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    October 23, 2025
    Report Date
    April 29, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00887868470011
    PMA / PMN Number
    K193373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): -110028055(791360). THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: A3; B4; B5; D2; G1; G3; G6; H1; H2; H3; H6; H10. THE REPORTED IS CONFIRMED THROUGH EVALUATION OF THE RETURNED DEVICE. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE DEVICE SHOWS SIGNS OF USE AS WELL AS WEAR AND TEAR. THE BASE HAS SEVERAL SCRATCHES AND DENTS FROM HEAVY USE. THE BODY HAS SEVERAL SCRATCHES AND DENTS AS WELL INCLUDING ON THE KNURLED SURFACE OF THE DEVICE. THERE IS WEAR ON THE PRONGS OF THE DEVICE ALSO. THERE IS NO VISIBLE BEND IN THE DEVICE AS STATED IN THE COMPLAINT. THE COMPLAINT ALSO STATES THE END CAP FRACTURED BUT THE END CAP WAS NOT RETURNED WITH THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND 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 THE IMPACTOR FRACTURED WHEN IMPACTING THE GLENOSPHERE WHILE FOLLOWING THE CORRECT SURGICAL PROCEDURE. THE PROCESS OF IMPACTING THE GLENOSPHERE WAS COMPLETED TO THE SURGEON'S SATISFACTION WITH THE INSTRUMENT. HOWEVER, IT WAS BROKEN IN THE PROCESS. NO BROKEN PIECES FELL INTO THE PATIENT. AND THE PATIENT HAS NOT EXPERIENCED ANY HARM DUE TO THE EVENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416356 COMPR RVS GLENO 2-PRNG INS/IMP SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. 67015470 00887868470011

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male