BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 9341552 · Received November 19, 2019

    Report

    Report Number
    1226188-2019-00180
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    October 22, 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

    A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY DATE IS UNKNOWN. DURING THE REVISION A POLY SWAP OCCURED REPLACING THE TIBIAL INSERT AND RETAINING BOLT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134943 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIA JWH OMNILIFE SCIENCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R