BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP INLK PRI TIB TRAY 65MM

    MDR report key: 7753619 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-04556
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    August 27, 2015
    Report Date
    March 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK132873
    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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD XP FEMORAL, CATALOG #: 195204, LOT #: 747010; SERIES A PATELLA STANDARD, CATALOG #: 184766, LOT #: 600430; VANGUARD XP E1 TIBIAL BEARING LATERAL, CATALOG #: 195772, LOT #: 628340; VANGUARD XP E1 TIBIAL BEARING MEDIAL, CATALOG #: 195842, LOT #: 940370; THIRD PIN, CATALOG #: 32-700036, LOT #: 531500; VANGUARD XP RECIPROCAL KEEL BLADE, CATALOG #: 32-700367, LOT #: 937077. 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.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI): (B)(4). THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED WITH NO DEVIATIONS OR ANOMALIES IDENTIFIED. 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 · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT SUFFERED RADIOLUCENCY AROUND MEDIAL SIDE OF TIBIAL TRAY.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594822 VGXP XP INLK PRI TIB TRAY 65MM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 206950

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other