BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR TIB BRG

    MDR report key: 22063365 · Received May 21, 2025

    Report

    Report Number
    0001825034-2025-01479
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    May 1, 2025
    Report Date
    August 26, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K023546
    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 - MEDICAL PRODUCT: POLISHED FINNED TIB TRAY 67MM CATALOG # 141252 LOT # UNK. VANGUARD CR POR FMRL-LT 57.5 CATALOG # 183062 LOT # UNK. G2: AUSTRALIA. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE REQUESTED BUT NOT RETURNED BY HOSPITAL. 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; B5; D2; D5; G1; G3; G6; H1; H2; H3; H6. THE EVENT IS CONFIRMED. VISUAL EXAMINATION OF THE PROVIDED PICTURE FOUND THE PROXIMAL MATING SURFACE TO SHOW WEAR AND DELAMINATION. AS THE DEVICE WAS NOT RETURNED, FURTHER EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FIFTEEN YEARS POST IMPLANTATION DUE TO ARTICULAR SURFACE WEAR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE 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
    2322016 VANGUARD CR TIB BRG PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. 691390

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H10 NARRATIVE.