BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 13291476 · Received January 19, 2022

    Report

    Report Number
    1226188-2021-00151
    Event Type
    Injury
    Date Received
    January 19, 2022
    Date of Event
    December 23, 2021
    Report Date
    January 19, 2022
    Manufacturer
    OMNI LIFE SCIECE, INC.
    Product Code
    JWH
    UDI-DI
    00841690101536
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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) 2021. THE ORIGINAL SURGERY DATE WAS ON (B)(6) 2014. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT, PATELLA AND RETAINING BOLT 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) 2021. THE ORIGINAL SURGERY DATE WAS ON (B)(6) 2014. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT, PATELLA AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804741 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNI LIFE SCIECE, INC. KC-36021 15874 00841690101536

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention| H