BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD POSTERIOR STABILIZED E1 TIBIAL BEARING 10MM X 63/67MM

    MDR report key: 20652348 · Received November 11, 2024

    Report

    Report Number
    0001825034-2024-02647
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    October 16, 2024
    Report Date
    January 6, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304465787
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES - BIOMET TIBIAL TRAY CATALOG #: 141232 LOT #: J6231056, VANGUARD POSTERIOR STABILIZED FEMORAL COMPONENT LEFT 62.5MM CATALOG #: 183126 LOT #: J6211456, SERIES A STANDARD 3 PEG PATELLA 31MM CATALOG #: 184764 LOT #: 053410 G2 - REPORT SOURCE - FOREIGN: EVENT OCCURRED IN JAPAN. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR 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, H6, H11. 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 TIBIAL BEARING FRACTURE AND DISCOMFORT APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, 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
    1569268 VANGUARD POSTERIOR STABILIZED E1 TIBIAL BEARING 10MM X 63/67MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 119410 00880304465787

    Patients

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