BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 12377052 · Received August 27, 2021

    Report

    Report Number
    1226188-2021-00101
    Event Type
    Injury
    Date Received
    August 27, 2021
    Date of Event
    August 2, 2021
    Report Date
    August 27, 2021
    Manufacturer
    OMNI LIFE SCIENCE
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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

    A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS UNKNOWN. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274245 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNI LIFE SCIENCE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R