BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR TIB BRG 12X71/75

    MDR report key: 20130443 · Received September 3, 2024

    Report

    Report Number
    0001825034-2024-02144
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    August 15, 2024
    Report Date
    December 26, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    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). D11 MEDICAL DEVICES: VANGUARD CR POR FEM-RT 70, CATALOG #: 183052, LOT #: 896730. POLISHED FINNED TIB TRAY 75MM, CATALOG #: 141254, LOT #: 20133060562. PALACOS R + G (1X40), CATALOG #: 66022663, LOT# : 76544333. G2 FOREIGN SOURCE: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT 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. UPDATED: B4, G3, G6, H2, H3, H6, AND H11. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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 PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY ELEVEN YEARS POST-IMPLANTATION DUE TO TIBIAL INSERT WEAR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    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
    735267 VANGUARD CR TIB BRG 12X71/75 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 384020

    Patients

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