BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI LIFE SCIENCE

    MDR report key: 8813656 · Received July 22, 2019

    Report

    Report Number
    1226188-2019-00113
    Event Type
    Injury
    Date Received
    July 22, 2019
    Date of Event
    June 4, 2019
    Report Date
    October 2, 2012
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    LPH
    UDI-DI
    00841690119906
    PMA / PMN Number
    K100555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT MADE NO INDICATION OF ANY OMNILIFE SCIENCE DEVICE MALFUNCTION OR DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR DEVICE PERFORMANCE CONTRIBUTING TO THE ADVERSE EVENT. 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 REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY OCCURED ON (B)(6) 2012. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED PATIENT PAIN. DURING THE REVISION, THE ACETABULAR INSERT WAS REMOVED AND REPLACED WITH A NEW COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607792 OMNI LIFE SCIENCE PROSTHESIS, HIP, SEMI-CONSTRAINED LPH OMNILIFE SCIENCE, INC. 11492 00841690119906

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R