BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MODULAR TIBIAL SYSTEM

    MDR report key: 7540579 · Received May 24, 2018

    Report

    Report Number
    0009610576-2018-00019
    Event Type
    Injury
    Date Received
    May 24, 2018
    Report Date
    May 24, 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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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. MEDICAL PRODUCTS: REFERENCES AND LOT NUMBERS NOT PROVIDED. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    DURING THE PERFORMANCE OF THE SCHEDULE PMS 17 BTMS SISTEMA MODULAR TIBIAL BIOMET REV.4, THE SURVEY PERFORMED BY (B)(6) REVEALS SOME ISSUES RELATED TO BIOMET MODULAR TIBIAL SYSTEM: IMPLANT REVISION DUE TO ASEPTIC LOOSENING .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383990 BIOMET MODULAR TIBIAL SYSTEM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R