BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 13602481 · Received February 25, 2022

    Report

    Report Number
    1226188-2022-00008
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    February 7, 2022
    Report Date
    February 25, 2022
    Manufacturer
    OMNI LIFE SCIECE, INC.
    Product Code
    JWH
    UDI-DI
    00841690100867
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. REVIEW OF THE MANUFACTURING DOCUMENTATION AND STERILIZATION DOCUMENTATION FOR THE DEVICES IN QUESTION REVEALED NO DEVIATION FROM PROCESS OR NON-CONFORMITY OF PRODUCT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    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. REVIEW OF THE MANUFACTURING DOCUMENTATION AND STERILIZATION DOCUMENTATION FOR THE DEVICES IN QUESTION REVEALED NO DEVIATION FROM PROCESS OR NON-CONFORMITY OF PRODUCT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 0

    A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY DATE IS (B)(6) 2021. THE REASON FOR REVISION IS REPORTED TO REMOVE SPACER THAT WAS IMPLANTED DURING FIRST STAGE REVISION. DURING THE REVISION, THE ORIGINAL FEMUR AND TIBIAL INSERT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

    Description of Event or Problem · 0

    A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY DATE IS (B)(6) 2021. THE REASON FOR REVISION IS REPORTED TO REMOVE SPACER THAT WAS IMPLANTED DURING FIRST STAGE REVISION. DURING THE REVISION, THE ORIGINAL FEMUR AND TIBIAL INSERT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2399310 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNI LIFE SCIECE, INC. KC-1104L 25724 00841690100867

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Hospitalization| R