BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIM IMPACTOR

    MDR report key: 24980069 · Received April 24, 2026

    Report

    Report Number
    3005751028-2026-00029
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 21, 2025
    Report Date
    April 24, 2026
    Manufacturer
    ZIMMER TMT
    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). NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, 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. H6: COMPONENT CODE: PROPOSED COMPONENT (ANNEX G) CODE IS: MECHANICAL (G04) - IMPACTOR. H10: THIS DEVICE WAS ERRONEOUSLY REPORTED UNDER AN INCORRECT MFR AND IS NOW BEING SUBMITTED UNDER THE APPROPRIATE MFR. SEE ORIGINAL REPORT 0001822565-2025-00878.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200087 RIM IMPACTOR INSTRUMENT, HIP HWE ZIMMER TMT NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown