BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD INTERLOK XP TIBIAL TRAY

    MDR report key: 7525646 · Received May 18, 2018

    Report

    Report Number
    0001825034-2018-03449
    Event Type
    Injury
    Date Received
    May 18, 2018
    Date of Event
    April 24, 2018
    Report Date
    August 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD INTERLOK FEMORAL COMPONENT, CATALOG #: 195923, LOT #: 244690, ARCOM SERIES-A STANDARD PATELLA, CATALOG #: 184768, LOT #: 143010, VANGUARD XP TIBIAL BEARING, CATALOG #: 195822, LOT #: 641550, VANGUARD AS TIBIAL BEARING, CATALOG #: 195563, LOT #: 091950. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03448, 0001825034-2018-03449. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, SWELLING AND A KNEE THAT IS HOT TO THE TOUCH. THE PATIENT ASSUMES METAL ALLERGIES ARE AN ISSUE AND HAS METAL TESTING SCHEDULED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367450 VANGUARD INTERLOK XP TIBIAL TRAY PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 841560

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other