BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG 12X63/67

    MDR report key: 17436224 · Received August 1, 2023

    Report

    Report Number
    0001825034-2023-01787
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    July 10, 2023
    Report Date
    July 31, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K171054
    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

    (B)(4). G2: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY THE FACILITY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS: 167026 VANGRD CR POR/HA FEM - RT 62.5, LOT# 2013063. 141272 BMET REGENX PRI TIB TRAY 67MM, LOT# 507270. 141314 BIOMET FINNED PRI STEM 40MM, LOT# 695600.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT WAS REVISED DUE TO POSTERIOR WEAR ON THE BEARING. THE BEARING WAS EXCHANGED WITHOUT ISSUE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343133 VNGD CR TIB BRG 12X63/67 PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 833940

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R