BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG

    MDR report key: 18379829 · Received December 21, 2023

    Report

    Report Number
    0001825034-2023-02964
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    December 1, 2023
    Report Date
    April 23, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PICTURES PROVIDED. VISUAL EVALUATION OF THE PROVIDED PICTURES SHOWS THAT THE ARTICULAR SHOWS WEAR ON THE PROXIMAL MATING SURFACE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4), D10 - MEDICAL PRODUCT: VANGUARD CR ILOK FEM-LT 72.5 CATALOG # 183033, LOT # 850610. PALACOS R + G (1X40) CATALOG # 66022663, LOT # 77814358 POLISHED FINNED TIB TRAY CATALOG # 141255, LOT # 2013101861. G2: AUSTRALIA H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. H3 OTHER TEXT : PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TO RESURFACE THE PATELLA AND EXCHANGE THE TIBIAL BEARING DUE TO DELAMINATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035378 VNGD CR TIB BRG PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 235310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H10 NARRATIVE.