BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD ANTERIOR STABILIZED TIBIAL BEARING 10MM X 75MM

    MDR report key: 20819014 · Received December 2, 2024

    Report

    Report Number
    0001825034-2024-02798
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    November 6, 2024
    Report Date
    February 27, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K050222
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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, G3, G6, H2, H3, H6, H11. EVALUATION OF A PHOTOGRAPH PROVIDED CONFIRMED EXCESSIVE WEAR ON THE DEVICE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES - VANGUARD FINNED POLISHED TIBIAL TRAY 75MM CATALOG #: 141254 LOT #: 2007061613, VANGUARD CRUCIATE RETAINING POROUS FEMORAL COMPONENT RIGHT 70MM CATALOG #: 183052 LOT #: 375770. G2 - REPORT SOURCE - FOREIGN: EVENT OCCURRED IN AUSTRALIA. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS SIGNIFICANT POLYETHYLENE WEAR ACCOMPANIED BY PAIN AND INFLAMMATION APPROXIMATELY SIXTEEN (16) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96888 VANGUARD ANTERIOR STABILIZED TIBIAL BEARING 10MM X 75MM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 904080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H