BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX HIP SYSTEM

    MDR report key: 4101719 · Received August 28, 2014

    Report

    Report Number
    1226188-2014-00050
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 31, 2014
    Manufacturer
    OMNLIFE SCIENCE INC.
    Product Code
    LPH
    PMA / PMN Number
    K073150
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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 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 HIP REVISION SURGERY IN (B)(6) 2014. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2009. THE REVISION SURGERY WAS PERFORMED BECAUSE OF SUSPECTED TRUNNIONOSIS AND ELEVATED COBALT LEVELS IN THE METAL ION SCREENING. THE ORIGINAL OMNI 36MM COCR HEAD WAS REMOVED AND REPLACED WITH A CERAMIC NON-OMNI HEAD, AND THE ACETABULAR INSERT WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526493 APEX HIP SYSTEM LPH OMNLIFE SCIENCE INC. 5852

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R