BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEMORAL

    MDR report key: 9151782 · Received October 3, 2019

    Report

    Report Number
    0001825034-2019-04445
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    September 9, 2019
    Report Date
    March 5, 2020
    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
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. 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

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET CC CRUCIATE TRAY; P/N: 141231, L/N: J3884994. E1 VNGD CRL TIB BRG; P/N: EP-183522, L/N: 141070. VANGUARD CR ILOK FEM-LT; P/N: 183028, L/N: J6077425. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 04386, 0001825034 - 2019 - 04445.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REVISION PROCEDURE 2 YEARS POST-IMPLANTATION DUE TO DUE TO PAIN, DIFFICULTY AMBULATING, HAVING TO USE A WALKER, INSTABILITY, AND SUBSIDENCE. SUBSEQUENTLY, LOOSENING OF THE COMPONENTS LEAD TO VALGUS ALIGNMENT. THE POLYETHYLENE BEARING, FEMORAL COMPONENT AND TIBIAL TRAY WAS REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945283 VANGUARD CR ILOK FEMORAL PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A J6077425

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R