BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE FEMUR RIGHT 60MM

    MDR report key: 6370957 · Received March 1, 2017

    Report

    Report Number
    3002806535-2017-00098
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    January 31, 2017
    Report Date
    March 1, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    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). CONCOMITANT MEDICAL PRODUCTS: VANGUARD RP STEMMED TIBIAL TRAY CATALOG 161412 LOT 0000712070; VANGUARD RP DEEP DISH BEARING CATALOG 187040 LOT 897798; SERIES A 3 PEG PATELLA CATALOG 184702 LOT 423970. THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMLIAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K945028.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE DUE TO LOOSENING OF THE FEMORAL COMPONENT APPROXIMATELY FOUR YEARS POST IMPLANTATION. THE FEMUR AND TIBIAL BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150289 VANGUARD COMPLETE KNEE FEMUR RIGHT 60MM PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A 2275535

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R