BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI HIP SYSTEM

    MDR report key: 6675322 · Received June 28, 2017

    Report

    Report Number
    1226188-2017-00061
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    May 18, 2017
    Report Date
    May 31, 2017
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    LZO
    UDI-DI
    00841690119333
    PMA / PMN Number
    K101451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 AND STERILIZATION DOCUMENTATION FOR THE DEVICES IN QUESTION REVEALED NO DEVIATION FROM PROCESS OR NON-CONFORMITY OF PRODUCT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP SURGERY ON (B)(6) 2017. DURING THE SURGERY, A BIOLOX FEMORAL HEAD WAS IMPLANTED 18 DAYS PAST EXPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456245 OMNI HIP SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED LZO OMNILIFE SCIENCE, INC. 11640 00841690119333

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization