BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD XP CR INTLK TIB TRAY 75MM

    MDR report key: 22412184 · Received July 7, 2025

    Report

    Report Number
    0001825034-2025-01986
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    June 16, 2025
    Report Date
    November 12, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00880304552814
    PMA / PMN Number
    K132873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, H2, H3, H6 THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF INFORMATION. MEDICAL RECORDS WERE NOT PROVIDED. VISUAL EXAMINATION OF THE PROVIDED IMAGES REVEALS THAT THE DEVICE EXHIBITS SIGNS OF USE (NICKS/SURFACE SCRATCHES). DIMENSIONAL ANALYSIS OF THE PRODUCT DETERMINED THAT THE PRODUCT, WHERE MEASURED, WAS CONFORMING TO PRINT SPECIFICATIONS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 195558, VGXP AS E1 TIB BRG LM/RL 11X75, LOT 221790. 195779, VGXP XP E1 TIB BRG RL 9X71, LOT 874910. 195910, VGXP INTLK FEMORAL RT 65, LOT 050170. G2: EVENT OCCURRED IN JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING 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

    NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 5 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION TO THE RIGHT KNEE DUE TO THE LOCKING BAR DISASSOCIATING. THE LOCKING BAR AND BEARING WERE REPLACED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND NONE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153603 VNGD XP CR INTLK TIB TRAY 75MM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. 193630 00880304552814

    Patients

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