BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD POSTERIOR STABILIZED TIBIAL BEARING 10MM X 71/75MM

    MDR report key: 23749664 · Received December 8, 2025

    Report

    Report Number
    0001825034-2025-03899
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 20, 2025
    Report Date
    February 27, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304271937
    PMA / PMN Number
    K113550
    Adverse Event
    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. VISUAL EVALUATION OF THE PICTURES PROVIDED IDENTIFIED EXPLANTED KNEE IMPLANTS COVERED IN BIO-DEBRIS. RADIOGRAPHS PROVIDED CONFIRMED THE REPORTED EVENT. 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 POSTERIOR STABILIZED OPEN FEMORAL COMPONENT 65MM. LEFT CATALOG #: 183128 LOT #: 686960, BIOMET POLISHED FINNED TIBIAL TRAY 71MM CATALOG #: 141253 LOT #: 2016020262. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B6, G3, G6, H2, H10, H11. THE FOLLOWING SECTIONS WERE CORRECTED: B5.

    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 LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS UNKNOWN COMPLICATIONS POST-OPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS INSTABILITY POST-OPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29148 VANGUARD POSTERIOR STABILIZED TIBIAL BEARING 10MM X 71/75MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH ZIMMER BIOMET, INC. 994040 00880304271937

    Patients

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