BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 3499454 · Received November 25, 2013

    Report

    Report Number
    1226188-2013-00097
    Event Type
    Injury
    Date Received
    November 25, 2013
    Date of Event
    October 23, 2013
    Report Date
    November 1, 2013
    Manufacturer
    OMNLIFE SCIENCE INC.
    Product Code
    JWH
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE IMPLANT WAS NOT RETURNED FOR EXAMINATION, AND DEVICE TRACEABILITY INFORMATION COULD NOT BE OBTAINED FOR A MANUFACTURING REVIEW. THE PRODUCT EXPLANTED IS OBSOLETE AND NO LONGER SOLD. THERE WAS NO REPORT OF DEFECT OR FAILURE TO MEET IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED A HIP REVISION SURGERY INVOLVING OMNI PRODUCT. THE SURGERY WAS ORIGINALLY PLANNED TO REVISE THE PATIENT'S ACETABULAR CUP, MADE BY ANOTHER MFR. DURING THE REVISION IT BECAME NECESSARY TO REVISE THE FEMORAL STEM, AN APEX MODULAR STEM, MANUFACTURED BY OMNILIFE SCIENCE, INC. NO INFORMATION COULD BE OBTAINED REGARDING THE ORIGINAL IMPLANTATION DATE, A PATIENT IDENTIFIER OR EXPLANTED PRODUCT MODEL/LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611137 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNLIFE SCIENCE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R