BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 79MM

    MDR report key: 7259209 · Received February 9, 2018

    Report

    Report Number
    0009610576-2018-00003
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    September 28, 2017
    Report Date
    February 9, 2018
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K945028.  INVOLVED PRODUCT NOT RETURNED DUE TO HOSPITAL POLICY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO MALALIGNMENT OF THE TIBIAL AND FEMORAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105209 POLISHED FINNED TIB TRAY 79MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2013061634

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention