BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 71MM

    MDR report key: 8459889 · Received March 28, 2019

    Report

    Report Number
    0009610576-2019-00005
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    January 14, 2019
    Report Date
    March 26, 2019
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ASSOCIATED PRODUCTS: REF. 183128; LOT J3898234; DESCRIPTION: VANGUARDTM PS INTERLOK FEMORAL 65MM LEFT; REF. EP-183640; LOT 549330; DESCRIPTION: VANGUARDTM E1TM PS TIBIAL BEARING 71/75 X 10MM. REPORT SOURCE: (B)(6). THIS PRODUCT IS MANUFACTURED BY BIOMET SPAIN ORTHOPAEDICS, S.L. AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WARSAW MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K945028. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019 THE SURGEON NOTICED A LOOSENING OF THE TIBIAL COMPONENT. A REVISION SURGERY IS PLANNED TO BE PERFORMED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252395 POLISHED FINNED TIB TRAY 71MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2016100174

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R