BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE

    MDR report key: 10005472 · Received April 28, 2020

    Report

    Report Number
    1226188-2020-00076
    Event Type
    Injury
    Date Received
    April 28, 2020
    Date of Event
    April 15, 2020
    Report Date
    April 28, 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 REPORTED INFECTION. DURING THE REVISION, ALL IMPLANTS WERE EXTRACTED AND TEMPORARY ONES WERE IMPLANTED FOR 6 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468614 APEX KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNILIFE SCIENCE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R