BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX HIP SYSTEM

    MDR report key: 5052855 · Received September 3, 2015

    Report

    Report Number
    1226188-2015-00062
    Event Type
    Injury
    Date Received
    September 3, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 28, 2015
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    LPH
    PMA / PMN Number
    K073150
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 AND STERILIZATION DOCUMENTATION FOR THE EXPLANTED DEVICES REVEALED NO DEVIATION FROM PROCESS OR NON-CONFORMITY OF PRODUCT THAT WOULD HAVE CAUSED THE ADVERSE EVENT.

    Description of Event or Problem · 1

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2015. THE ORIGINAL SURGERY WAS DATED (B)(6) 2015. THE REVISION SURGERY WAS DUE TO PATIENT HIP DISLOCATION. IN THE REVISION, THE SIZE 36MM, 0 DEGREE HOOD ACETABULAR INSERT WAS REVISED TO A 36MM, 10 DEGREE HOOD ACETABULAR INSERT. THE 36MM X 0MM FEMORAL HEAD WAS ALSO REVISED TO A 36MM X +4MM FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583857 APEX HIP SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED LPH OMNILIFE SCIENCE, INC. 18865

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R