BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SHOULDER INSTRUMENTS MINI HUMERAL REAMER

    MDR report key: 23838449 · Received December 18, 2025

    Report

    Report Number
    0001825034-2025-04050
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    July 9, 2025
    Report Date
    January 16, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K193038
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): D10: ITEM# 113626; LOT# 710590. ITEM# 41-406805; LOT# UNKNOWN. G2: FOREIGN - EVENT OCCURRED IN THE NETHERLANDS. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. 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.

    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; H10. THE BROACH WAS NOT RETURNED TO COMPLETE VISUAL EXAMINATION. MEDICAL RECORDS WERE NOT PROVIDED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS; LOT IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT WAS UNABLE TO BE 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 THAT DURING AN INITIAL SHOULDER ARTHROPLASTY, THE PLACEMENT OF THE STEM WAS UNSUCCESSFUL. IT WAS NOTED THAT IT WAS NOT POSSIBLE TO INSERT THE STEM DEEPLY ENOUGH INTO THE HUMERAL SHAFT. SUBSEQUENTLY, REPEATED REAMING ALSO YIELDED NO IMPROVEMENT. DUE TO EXCESSIVE TENSION, AVULSION OF THE CONJOINED ROTATOR CUFF TENDON OCCURRED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244461 COMPREHENSIVE SHOULDER INSTRUMENTS MINI HUMERAL REAMER PROSTHESIS, SHOULDER, SEMI-CONSTRAINED MBF ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE NARRATIVE IN H11.