BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX HIP SYSTEM

    MDR report key: 4930969 · Received July 20, 2015

    Report

    Report Number
    1226188-2015-00052
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 24, 2015
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    LPH
    PMA / PMN Number
    K000788
    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 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) 2003. THE REVISION SURGERY WAS DUE TO THE NON-OMNI ACETABULAR CUP BECOMING WORN. IN THE REVISION, THE ORIGINAL OMNI STEM, AND MODULAR NECK REMAINED WHILE THE ORIGINAL OMNI COBALT CHROME HEAD WAS REMOVED AND REPLACED WITH A NEW IMPLANT OF THE SAME SIZE AS A PRECAUTION. THE ACETABULAR CUP AND LINER WERE REPLACED WITH NON-OMNI PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469730 APEX HIP SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED LPH OMNILIFE SCIENCE, INC. 256

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R