BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS TIB BRG 14X79/83MM

    MDR report key: 24886464 · Received April 15, 2026

    Report

    Report Number
    0001825034-2026-00952
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 15, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304272033
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: VAN PS OPEN INTL FEM-RT 72.5: CATALOG#: 183113, LOT#: J6343129; BIOMET CC CRUCIATE TRAY 79MM: CATALOG#: 141235, LOT#: J6428603; SERIES A PAT STD 37 3 PEG: CATALOG#: 184768, LOT#: 594170. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY SEVEN (7) YEARS AND THREE (3) MONTHS POST-IMPLANTATION, THE PATIENT DEVELOPED PAIN, SWELLING, INSTABILITY, AND POSTERIOR SUBLUXATION OF THE TIBIA. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION WHERE THE POST OF THE ARTICULAR SURFACE WAS FOUND FREE FLOATING. THE BEARING WAS REVISED WITHOUT COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946381 VANGUARD PS TIB BRG 14X79/83MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 944750 00880304272033

    Patients

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