BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HA STEM

    MDR report key: 2963491 · Received February 13, 2013

    Report

    Report Number
    1226188-2013-00004
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 9, 2013
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    LPH
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORT FROM THE SURGEON THERE WAS NO IMPLICATION OF THIS DEVICE BEING RELATED TO THE REVISION SURGERY. A REVIEW OF THE BATCH RECORDS WAS DONE TO CONFIRM THAT THERE WERE NO DEFECTS OF DEVIATIONS REPORTED AT THE TIME OF MANUFACTURING. THE IMPLANT WAS NOT RETURNED FOR EXAMINATION AND THEREFORE OMNI COULD NOT CONFIRM THE LOT NUMBERS OF THE PRODUCT REPORTED. BASED ON THE INFORMATION PROVIDED, A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND THERE WAS NO EVIDENCE IN THE FILES THAT SHOWED ANY DEFECTS OR DEVIATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT HAD A REVISION SURGERY TO REPLACE A LINER IN A WRIGHT MEDICAL CUP, NOT AN OMNI PRODUCT. THE OMNI MODULAR NECK WAS REMOVED AND REPLACED TO PROVIDE SURGEON BETTER ACCESS TO SURGICAL SITE DURING THE WRIGHT MEDICAL LINER REPLACEMENT. THERE WERE NO ISSUES REPORTED WITH THE OMNI MODULAR NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62725 APEX MODULAR HA STEM MODULAR FEMORAL NECK LPH OMNLIFE SCIENCE, INC. 1464

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R