BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI HIP SYSTEM

    MDR report key: 10760237 · Received October 30, 2020

    Report

    Report Number
    1226188-2020-00189
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Date of Event
    October 15, 2020
    Report Date
    October 29, 2020
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    LPH
    UDI-DI
    00841690102410
    PMA / PMN Number
    K031110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING DOCUMENTATION AND STERILIZATION DOCUMENTATION FOR THE DEVICES IN QUESTION REVEALED NO DEVIATION FROM PROCESS OR NON-CONFORMITY OF PRODUCT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP SURGERY. DURING THE SURGERY AN APICAL PLUG WAS USED ON AN IMPLANT SIZE IT IS NOT RECOMMENDED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231706 OMNI HIP SYSTEM PROSTHESIS, HIP, SEMICONTRAINED LPH OMNILIFE SCIENCE, INC. 400000 21353 00841690102410

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization