BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 8921991 · Received August 22, 2019

    Report

    Report Number
    1226188-2019-00126
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    July 24, 2019
    Report Date
    August 22, 2019
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    JWH
    UDI-DI
    00841690121220
    PMA / PMN Number
    K112891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    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

    A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A PRIMARY KNEE SURGERY ON (B)(6) 2019. DURING THE SURGERY AN EXPIRED FEMORAL COMPONENT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715840 APEX KNEE SYSTEM PROSTHESIS, KNEE PATELOFEMOROTIBIA JWH OMNILIFE SCIENCE, INC. 15362 00841690121220

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization