BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS TIB BRG 12X79/83MM

    MDR report key: 24852037 · Received April 11, 2026

    Report

    Report Number
    0001825034-2026-00912
    Event Type
    Injury
    Date Received
    April 11, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 10, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    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: MEDICAL PRODUCT: POLISHED FINNED TIB TRAY 79MM: CATALOG#: 141255, LOT#: 2011080076; VAN PS OPEN INTL FEM-LT 72.5: CATALOG#: 183133, LOT#: 388510; CMT CMW T. 1 AVEC ANTIBIOTIQUE: CATALOG#: 3315040, LOT#: 3409094. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY FOURTEEN (14) YEARS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE INSTABILITY IN THE JOINT AS THE POST OF THE POLYETHYLENE BEARING HAD FRACTURED. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE FRACTURED BEARING WITHOUT REPORTED COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910850 VANGUARD PS TIB BRG 12X79/83MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 071670

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.