BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD PS+ TIB BRG 59X10

    MDR report key: 11948184 · Received June 7, 2021

    Report

    Report Number
    0001825034-2021-01728
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 24, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304480018
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, AND H10. NO PRODUCT WAS RETURNED OR NO PHOTOGRAPHS WERE PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2021-01726, 0001825034-2021-01727. MEDICAL PRODUCT: VNGD PS OPEN INTL FEM-RT 57.5, ITEM# 183102, LOT# J6448073. VANGUARD FEM PEGS SET 2, ITEM# 183099, LOT# 329220. BIOMET BC R 1X40 US, ITEM# 110035368 LOT# 915FAA0805. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR AND ONE-MONTH POST IMPLANTATION DUE TO INSTABILITY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845890 E1 VNGD PS+ TIB BRG 59X10 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 328950 00880304480018

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R