BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM

    MDR report key: 6180551 · Received December 16, 2016

    Report

    Report Number
    3002806535-2016-00909
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    October 12, 2016
    Report Date
    December 16, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    MBH
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K060303.

    Description of Event or Problem · 1

    DURING A LEFT TOTAL KNEE ARTHROPLASTY, AFTER THE FEMUR WAS IMPLANTED, SCRATCHES WERE NOTICED ON THE DISTAL CONDYLES OF THE FEMUR. THE SURGEON REMOVED THE FEMUR AND COMPLETED THE PROCEDURE WITH ANOTHER FEMUR AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830884 VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM PROSTHESIS, KNEE MBH BIOMET UK LTD. N/A 2687256

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention