BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIBIAL TRAY 75MM

    MDR report key: 6487339 · Received April 12, 2017

    Report

    Report Number
    0009610576-2017-00013
    Event Type
    Injury
    Date Received
    April 12, 2017
    Date of Event
    March 13, 2017
    Report Date
    April 12, 2017
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    PMA / PMN Number
    PSEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF BIRTH - (B)(6). CONCOMITANT MEDICAL PRODUCTS: VAN PS OPEN INTL FEM-LT 70, CATALOG# 183132, LOT# 702110; SIG TKA GDE/MDL SET 04-05, CATALOG# 42-422561, LOT# 170540; VANGUARD PS TIB BRG 71/75 X 10MM, CATALOG# 183640, LOT# 227540. EVENT OCCURRED IN (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (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 510K NUMBER K945028. THE DEVICE HAS NOT BEEN RETURNED TO DATE FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY FOURTEEN DAYS POST-IMPLANTATION DUE TO THE LOCKING BAR NOT SEATING CORRECTLY. THE POLYETHYLENE BEARING WAS REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268556 POLISHED FINNED TIBIAL TRAY 75MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. 2016050100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R