BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 17164100 · Received June 20, 2023

    Report

    Report Number
    1226188-2023-00121
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    June 13, 2023
    Report Date
    September 11, 2023
    Manufacturer
    OMNILIFE SCIENCE INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL REPORT. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED. THE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. ADDITIONAL INFORMATION WAS REQUESTED, SUCH AS XRAYS, OPERATIVE NOTES, PATIENT ACTIVITY LEVEL AND MEDICAL HISTORY, DID THE PATIENT EXPERIENCE ANY TRAUMA, DID PATIENT FOLLOW CORRECT POST-OP PROTOCOL AND AN UPDATE ON THE PATIENT POST REVISION. CONCLUSIONS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. PLEASE NOTE: THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    (B)(4) FINAL REPORT THE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED ON THE REVISED PARTS. . PARTS FROM KC-53000 LOT 28555 AND KC-36034 LOT 24596 CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURE. A CONCESSION WAS RAISED ON KC-2204R LOT 26072 ON A DIMENSIONAL NON-CONFORMANCE WHICH WOULD NOT AFFECT THE FUNCTIONALITY OF THE IMPLANT. IT IS THE FIRST TIME THAT LOOSENING IS REPORTED ON PARTS FROM THIS BATCH. ADDITIONAL INFORMATION, SUCH AS XRAYS, OPERATIVE NOTES, PATIENT ACTIVITY LEVELS, MEDICAL HISTORY, DID THE PATIENT EXPERIENCE ANY TRAUMA, AND AN UPDATE ON THE PATIENT POST-REVISION WERE REQUESTED ON (B)(4) 2023 JUNE AND JULY. NO ADDITIONAL INFORMATION WAS PROVIDED. BASED ON THIS, NO FURTHER INVESTIGATION CAN BE PERFORMED. THE ROOT CAUSE REMAINS UNKNOWN AND THIS CASE IS NOW CONSIDERED CLOSED. IF ADDITIONAL INFORMATION IS PROVIDED, THE CASE MAY BE REOPENED. PLEASE NOTE: THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    APEX TIBIAL BASEPLATE, INSERT AND LOCKING BOLT REVISION AFTER 5 YEARS DUE TO LOOSENING.

    Description of Event or Problem · 0

    APEX TIBIAL BASEPLATE, INSERT AND LOCKING BOLT REVISION AFTER 5 YEARS DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546565 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH OMNILIFE SCIENCE INC. KC-36034 24596

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| H APEX BOLT KC-53000 LOT 28555| APEX FEMUR KC-1103R LOT 24698| APEX PATELLA KC-40410 LOT 27144| TIBIAL BASEPLATE KC-2204R LOT 26072