BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 67MM

    MDR report key: 8459908 · Received March 28, 2019

    Report

    Report Number
    0009610576-2019-00006
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    January 10, 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: REF. (B)(4); LOT J3795010; DESCRIPTION: VANGUARDTM PS INTERLOK FEMORAL 62,5MM LEFT; REF. (B)(4); LOT 770970; DESCRIPTION: VANGUARDTM E1TM PS TIBIAL BEARING 63/67 X 10MM. FOREIGN SOURCE: SWITZERLAND. 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 THE SURGEON NOTICED A LOOSENING OF THE TIBIAL COMPONENT ON (B)(6) 2019. A REVISION SURGERY IS PLANNED TO BE PERFORMED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252836 POLISHED FINNED TIB TRAY 67MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2016051961

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R