BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPR METAL IMPACTOR

    MDR report key: 23569199 · Received November 17, 2025

    Report

    Report Number
    0001825034-2025-03649
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 23, 2025
    Report Date
    March 18, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00887868470103
    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). D10: MEDICAL PRODUCTS: ITEM#: 110028055, COMPR 3-IN-1 IMPACTOR; LOT#: 844020. H3: 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NEITHER IMPACTOR HAD THE POLY IMPACTOR TIP RETURNED WITH THE DEVICE. VISUAL EXAMINATION OF THE RETURNED PRODUCTS IDENTIFIED SIGNS OF USE WITH WITNESS MARKS ON THE STRIKE PLATE AND WEAR AND TEAR ON THE HANDLES OF THE IMPACTORS. BOTH THREADS ON THE DISTAL ENDS OF THE DEVICE HAVE EPOXY RESIDUE ON THE THREADS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 THAT WHILE THE SURGEON WAS USING THE INSTRUMENT TO IMPLANT THE IMPLANT, THE TIP OF THE INSTRUMENT FRACTURED. THERE WAS NO FOREIGN BODY OR HARM TO THE PATIENT.

    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
    274464 COMPR METAL IMPACTOR SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 613600 00887868470103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown