BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 13062064 · Received December 22, 2021

    Report

    Report Number
    1226188-2021-00143
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    November 22, 2021
    Report Date
    December 22, 2021
    Manufacturer
    OMNI LIFE SCIECE, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    OMNI LIFE SCIENCE BECAME AWARE OF OFF LABEL USE OF OUR IMPLANTS ON 11/30/2021. A NON-OMNI POLYBOLT WAS USED WITH OMNI IMPLANTS. AS A COMPANY THE DECISION WAS MADE TO REPORT AS A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1967655 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNI LIFE SCIECE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown