BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIM IMPACTOR

    MDR report key: 21760989 · Received April 3, 2025

    Report

    Report Number
    0001822565-2025-00878
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 21, 2025
    Report Date
    April 24, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SUGGESTED COMPONENT CODE: MECHANICAL (G04) - IMPACTOR. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. 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 {UPDATE/CORRECTED} UPDATED: G3; H2; H6 SUGGESTED COMPONENT CODE: MECHANICAL (G04) ¿ IMPACTOR NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON AN INTERNAL DATA REVIEW, IT WAS DETERMINED THAT THIS DEVICE WAS REPORTED UNDER THE INCORRECT MANUFACTURER. THIS REPORT SHOULD BE CONSIDERED VOID, AND THE EVENT WILL BE REPORTED UNDER MFR 3005751028.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPACTOR BROKE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON AN INTERNAL DATA REVIEW, IT WAS DETERMINED THAT THIS DEVICE WAS REPORTED UNDER THE INCORRECT MANUFACTURER. THIS REPORT SHOULD BE CONSIDERED VOID, AND THE EVENT WILL BE REPORTED UNDER MFR 3005751028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410218 RIM IMPACTOR INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE ZIMMER BIOMET, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown