BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD XP INLK PRI TIB TRAY 69MM

    MDR report key: 7777960 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-04609
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    February 24, 2015
    Report Date
    October 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK122160
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT CANNOT BE CONFIRMED. NO PRODUCTS WERE RETURNED AS THEY REMAIN IMPLANTED AND NO SURGICAL NOTES WERE PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE CANNOT BE DETERMINED. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT SUFFERED RADIOLUCENCY A YEAR POST IMPLANTATION.

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: VANGUARD INTERLOK FEMORAL COMPONENT, CATALOG # 195205, LOT # 853530; VANGUARD XP TIBIAL BEARING, CATALOG # 195334, LOT # 878100; VANGUARD XP TIBIAL BEARING, CATALOG # 195404, LOT # 575580. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT SUFFERED RADIOLUCENCY A YEAR POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619390 VNGD XP INLK PRI TIB TRAY 69MM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 764350

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other