BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-RT 70

    MDR report key: 8394531 · Received March 6, 2019

    Report

    Report Number
    0001825034-2019-00640
    Event Type
    Injury
    Date Received
    March 6, 2019
    Report Date
    November 21, 2019
    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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS IS A DUPLICATE COMPLAINT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND WILL BE VOIDED. THE EVENT WILL BE REPORTED UNDER 0001825034-2019-00933. 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 IS A DUPLICATE COMPLAINT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND WILL BE VOIDED. THE EVENT WILL BE REPORTED UNDER 0001825034-2019-00933.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR ILOK FEM; P/N: 183012, L/N: 432290. BIOMET CC CRUCIATE TRAY; P/N: 141235, L/N: J3333616. VNGD CR TIB BRG; P/N: 183466, L/N: 720010. OPTIPAC 40 REFOBACIN BN CMT R; P/N: 4710500394, L/N: UNK. REPORT SOURCE - FOREIGN: (B)(6). 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: 0001825034-2019-00641.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT IS BEING CONSIDERED FOR A REVISION PROCEDURE 5 YEARS POST-IMPLANTATION DUE TO MALPOSITION WHICH LEAD TO INSTABILITY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187021 VANGUARD CR ILOK FEM-RT 70 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 432290

    Patients

    Seq Age Sex Outcome Treatment
    1 Other