BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS OPEN INTL FEM RT 75

    MDR report key: 24832781 · Received April 9, 2026

    Report

    Report Number
    0001825034-2026-00907
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    May 6, 2021
    Report Date
    April 9, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304270824
    PMA / PMN Number
    K113550
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: VNGD PS+ TIB BRG 10X79/83 MM: CATALOG#183760, LOT#531780; BIOMET ILOK PRI TIB TRAY 79 MM: CATALOG#141215, LOT#NI; BIOMET FINNED PRI STEM 40 MM: CATALOG#141314, LOT#NI; COBALT G-HV BONE CEMENT 40GM: CATALOG#600-15-100, LOT# NI. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - FEMUR. 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 BY LEGAL THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. A FEW YEARS POSTOP, THE PATIENT REPORTEDLY STEPPED ON A BOOK WHICH BROKE APART THE IMPLANTED COMPONENTS RESULTING IN DIFFICULTY AMBULATING AND PAIN AND ALLOWED THE KNEE TO BE ROTATED INDEPENDENTLY ABOVE AND BELOW THE PROSTHESIS. SUBSEQUENTLY, THREE (3) YEARS AND SEVEN (7) MONTHS POST-IMPLANTATION, A REVISION OF UNKNOWN COMPONENTS WAS PERFORMED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895792 VANGUARD PS OPEN INTL FEM RT 75 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 370100 00880304270824

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE.