BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET POLISHED FINNED TIBIAL TRAY 71MM

    MDR report key: 23789212 · Received December 12, 2025

    Report

    Report Number
    0001825034-2025-03966
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    November 20, 2025
    Report Date
    February 27, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES - VANGUARD POSTERIOR STABILIZED TIBIAL BEARING 10MM X 71/75MM. CATALOG #: 183640 LOT #: 994040, VANGUARD POSTERIOR STABILIZED OPEN FEMORAL COMPONENT 65MM. LEFT CATALOG #: 183128 LOT #: 686960. 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 INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H4, H6, H10, H11. 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.

    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.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703452 BIOMET POLISHED FINNED TIBIAL TRAY 71MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 2016020262

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.