BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX HIP SYSTEM

    MDR report key: 2963513 · Received February 13, 2013

    Report

    Report Number
    1226188-2013-00012
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    LZO
    PMA / PMN Number
    K101451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANTS WERE NOT RETURNED FOR EXAMINATION; THEREFORE, OMNI COULD NOT CONFIRM THE LOT NUMBERS OF THE PRODUCT REPORTED. BASED ON THE INFORMATION PROVIDED, A REVIEW OF MANUFACTURING WAS PERFORMED. ALL IMPLANT LOT RECORDS OF EXPLANTED OMNI PRODUCT WERE REVIEWED AND THERE WERE NO DEVIATIONS REPORTED. BASED ON THE INFORMATION PROVIDED, THE REVISION SURGERY WAS REQUIRED DUE TO TENDONITIS IN THE PATIENT, THERE WAS NO INDICATION FROM THE SURGEON THAT THERE WAS AN ISSUE WITH ANY OF THE OMNI IMPLANTS.

    Description of Event or Problem · 1

    SALES REPRESENTATIVE REPORTED THAT PATIENT WAS HAVING PAIN DUE TO TENDONITIS. THE SURGEON PERFORMED REVISION SURGERY TO REMOVE AND REPLACE THE FEMORAL HEAD AND ACETABULAR INSERT. INITIAL SURGERY WAS ON (B)(6) 2011 AND REVISION SURGERY WAS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63877 APEX HIP SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED LZO OMNLIFE SCIENCE, INC. 3948

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R