BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CRUCIATE RETAINING TIBIAL BEARING 12MM X 63/67MM

    MDR report key: 21763617 · Received April 3, 2025

    Report

    Report Number
    0001825034-2025-00975
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    August 16, 2021
    Report Date
    July 28, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES - VANGUARD CRUCIATE RETAINING POROUS FEMORAL COMPONENT RIGHT 62.5MM CATALOG #: 183046 LOT #: 839190, BIOMET CRUCIATE TIBIAL TRAY 67MM CATALOG #: 141232 LOT #: J2460941, SERIES A STANDARD 3 PEG PATELLA 34MM CATALOG #: 184766 LOT #: 221220. 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, H4, H6, H11. MEDICAL RECORDS 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 RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, INSTABILITY, DIFFICULTY AMBULATING AND ASEPTIC FAILURE OF THE FEMORAL COMPONENT APPROXIMATELY TEN (10) 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
    614921 VANGUARD CRUCIATE RETAINING TIBIAL BEARING 12MM X 63/67MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 276610

    Patients

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