BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-RT 67.5

    MDR report key: 16459731 · Received March 1, 2023

    Report

    Report Number
    0001825034-2023-00419
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    October 17, 2022
    Report Date
    March 1, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    UDI-DI
    00880304270428
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS & MDRS: 189103 VNGD ANT STAB BRG 13X79, LOT#: 408490. MDR: 0001825034-2023-00420. ADDITIONAL ASSOCIATED PRODUCTS: 141314 BIOMET FINNED PRI STEM 40MM, LOT#: 239970; 141215 BIOMET ILOK PRI TIB TRAY 79MM, LOT#: 501280; 184766 SERIES A PAT STD 34 3 PEG, LOT#: 338010.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY PERFORMED. SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY 2 MONTHS POST IMPLANTATION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AND PATIENT REMAINS SATISFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142132 VANGUARD CR ILOK FEM-RT 67.5 PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A J7215821 00880304270428

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H