BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 75MM

    MDR report key: 8934062 · Received August 27, 2019

    Report

    Report Number
    0009610576-2019-00013
    Event Type
    Injury
    Date Received
    August 27, 2019
    Date of Event
    July 29, 2019
    Report Date
    August 27, 2019
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED BY BIOMET (B)(4) ORTHOPAEDICS, (B)(4). AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K945028. REQUESTED BUT NOT RETURNED BY HOSPITAL.

    Description of Event or Problem · 1

    PRIMARY SURGERY WAS CONVERTED TO A FIRST STAGE DUE TO UNCERTAINTY OVER POSSIBLE INFECTION. TESTS RETURNED CLEAR AND THE SECOND STAGE SURGERY WAS PERFORMED ON (B)(6) 2019. THIS WAS NOT A REVISION OF COMPONENTS BUT RATHER A SECOND STAGE SURGERY CONVERTING THE TEMPORARY VANGUARD TO A 360. INITIAL SURGERY WAS PERFORMED BY (B)(6) ON (B)(6) 2019. REVISION SURGERY OF THE INVOLVED PRODUCT (REF: 141254; LOT: 2018050406) ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731231 POLISHED FINNED TIB TRAY 75MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2018050406

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R