BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX HIP SYSTEM

    MDR report key: 3601795 · Received January 17, 2014

    Report

    Report Number
    1226188-2014-00001
    Event Type
    Injury
    Date Received
    January 17, 2014
    Date of Event
    December 18, 2013
    Report Date
    December 19, 2013
    Manufacturer
    OMNLIFE SCIENCE
    Product Code
    LPH
    PMA / PMN Number
    K04312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SALES REP INDICATED A RETURN OF THE PRODUCT, BUT IT HAS NOT BEEN RECEIVED TO BE EVALUATED. REVIEW OF THE MFG DOCUMENTATION FOR THE DEVICE 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 PT WHO UNDERWENT HIP REVISION SURGERY ON (B)(6) 2013. THE ORIGINAL SURGERY WAS DATED (B)(6) 2013. BOTH SURGERIES INVOLVED IMPLANTATION OF OMNILIFE DEVICES. THE REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE ARC STEM. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44483 APEX HIP SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED LPH OMNLIFE SCIENCE 12927

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R