BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGARD CR TIB BRG 10X71/75

    MDR report key: 25065172 · Received May 4, 2026

    Report

    Report Number
    0001825034-2026-01184
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 8, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 66022663 - PALACOS R + G (1X40) - (B)(6). 183070 - VANGUARD CR POR FMRL-LT 67.5 - (B)(6). 141253 - POLISHED FINNED TIB TRAY 71MM - (B)(6). G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 14 YEARS POST IMPLANTATION. IT WAS OBSERVED WEAR IN THE BEARING. THE POLY WAS EXCHANGED. THE FEMUR AND THE TIBIA REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428752 VANGARD CR TIB BRG 10X71/75 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 515110

    Patients

    Seq Age Sex Outcome Treatment
    1