BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI HIP SYSTEM

    MDR report key: 6576586 · Received May 18, 2017

    Report

    Report Number
    1226188-2017-00046
    Event Type
    Injury
    Date Received
    May 18, 2017
    Date of Event
    April 18, 2017
    Report Date
    April 20, 2017
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    KWY
    UDI-DI
    00841690118909
    PMA / PMN Number
    K110947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    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

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF LOOSENING OF THE HIP STEM. DURING THE REVISION, THE ORIGINAL SIZE 0 STEM, 49MM X 28MM BIPOLAR HEAD AND 28MM X +0MM COBALT CHROME FEMORAL HEAD WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

    Description of Event or Problem · 1

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF INSTABILITY. DURING THE REVISION, THE ORIGINAL SIZE 0 STEM, 49MM X 28MM BIPOLAR HEAD AND 28MM X +0MM COBALT CHROME FEMORAL HEAD WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357648 OMNI HIP SYSTEM PROSTHESIS, HIP, HEMI-, FEMORAL KWY OMNILIFE SCIENCE, INC. 18547 00841690118909

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R