BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VANGUARD FEMORAL

    MDR report key: 22700690 · Received August 4, 2025

    Report

    Report Number
    0001825034-2025-02354
    Event Type
    Injury
    Date Received
    August 4, 2025
    Report Date
    August 4, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. D10- MEDICAL PRODUCT: VG DA360 TIB BRG ARCM 79/83X14 3 X 14MM, ITEM# 161455, LOT# UNKNOWN. G2- UNITED KINGDOM. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS AND THE PART AND LOT NUMBER WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS NOT 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. PROPOSED ANNEX G CODE: MECHANICAL (G04) ¿ FEMUR.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT IS EXPERIENCING INSTABILITY POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205724 UNKNOWN VANGUARD FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11