BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MODULAR TIBIAL SYSTEM -POLISHED FINNED TIBIAL TRAY 71 MM

    MDR report key: 7286102 · Received February 21, 2018

    Report

    Report Number
    0009610576-2018-00004
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    August 23, 2017
    Report Date
    February 21, 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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS: P/N 183126 LOT J3688009, P/N EP-183642 LOT 522340. THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMLIAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K945028.  THIS EVENT WAS PREVIOUSLY REPORTED UNDER 0001825034-2017-09392.

    Description of Event or Problem · 1

    IT HAS BEEN THAT THE PATIENT UNDERWENT A REVISION SURGERY 7 MONTHS POST INITIAL KNEE SURGERY DUE TO PAIN AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130075 BIOMET MODULAR TIBIAL SYSTEM -POLISHED FINNED TIBIAL TRAY 71 MM PROSTHESIS KNEE KRO BIOMET SPAIN, S.L. N/A 2016021853

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R