BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE

    MDR report key: 10189876 · Received June 24, 2020

    Report

    Report Number
    1226188-2020-00105
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    June 15, 2020
    Report Date
    June 24, 2020
    Manufacturer
    OMNILIFE SCIENCE INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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)2020. THE ORIGINAL SURGERY DATE IS UNKNOWN. THE REASON FOR REVISION IS SUSPECTED INFECTION. DURING THE REVISION, A NEW INSERT AND RETAINING BOLT WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652354 APEX KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNILIFE SCIENCE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R