BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 8478815 · Received April 3, 2019

    Report

    Report Number
    1226188-2019-00049
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    January 9, 2019
    Report Date
    April 3, 2019
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    JWH
    Adverse Event
    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.

    Description of Event or Problem · 1

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY DATE IS UNKNOWN. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270339 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIA JWH OMNILIFE SCIENCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R