BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI HIP SYSTEM

    MDR report key: 6046656 · Received October 21, 2016

    Report

    Report Number
    1226188-2016-00084
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 23, 2016
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    LPH
    PMA / PMN Number
    K031110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2016. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF DISLOCATION. DURING THE REVISION, ALL ORIGINAL OMNI ACETABULAR SHELL, INSERT, AND FEMORAL HEAD WERE REMOVED AND REPLACED WITH NEW COMPONENTS. THE ORIGINAL 54MM SHELL WAS REPLACED WITH A 60MM SHELL, THE ORIGINAL 36MM X -4MM FEMORAL HEAD WAS REPLACED WITH A 36MM X +8MM HEAD, AND THE ORIGINAL 36MM 0 DEGREE HOOD INSERT WAS REPLACED WITH A 36MM 10 DEGREE HOODED IMPLANT. IN ADDITION TO THE REVISED COMPONENTS, 2 CANCELLOUS BONE SCREWS WERE IMPLANTED. THE ORIGINAL FEMORAL STEM WAS LEFT UNREVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699949 OMNI HIP SYSTEM PROSTHESIS, HIP, SEMI-CONTRAINED LPH OMNILIFE SCIENCE, INC. 16574

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R