BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 16715634 · Received April 11, 2023

    Report

    Report Number
    1226188-2023-00100
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    April 6, 2023
    Report Date
    October 12, 2023
    Manufacturer
    OMNILIFE SCIENCE INC.
    Product Code
    JWH
    PMA / PMN Number
    K073602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY DATE (B)(6) 2020. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION NO IMPLANTS WERE REMOVED. THE PATELLA WAS RESURFACED WITH A PATELLA BUTTON. NO IMPLANT ISSUE SURGEON PREFERENCE TO NOT RESURFACE PATELLA DURING PRIMARY SURGERY. ORIGINAL IMPLANTS REMAIN IN SUTI. 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. 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) INITIAL REPORT. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED. THE CORRESPONDING MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. XRAYS WERE PROVIDED. CONCLUSIONS OF THE REVIEW WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. ADDITIONAL INFORMATION WAS REQUESTED, SUCH AS OPERATIVE NOTES, PATIENT ACTIVITY LEVEL AND MEDICAL HISTORY, DID THE PATIENT EXPERIENCE ANY TRAUMA, DID THE PATIENT FOLLOW THE CORRECT POST-OP PROTOCOL AND AN UPDATE ON THE PATIENT POST-REVISION. CONCLUSIONS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. 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. THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 0

    APEX KNEE REVISED DUE TO ANTERIOR KNEE PAIN. THE PATELLA WAS NOT RESURFACED IN THE PRIMARY CASE AND WAS RESURFACED WITH A 32X8MM PATELLA BUTTON. PRIMARY SURGERY DETAILS: BK176043 - 20-FEB-2020 - DR (B)(6) - (B)(6) HOSPITAL. PRIMARY IMPLANTS: ARTG # 286880 - PART # KC-1425R - KNEE FEMUR UNCEMENTED (POROUS COATED), SZ 2+ RT HF - LOT # 35350 (LEFT IN SITU). ARTG # 278528 - PART # KC-2202R - SZ 2 RT PRIMARY TIBIAL BASEPLATE CEMENTED (NON POROUS) - LOT # 31292 (LEFT IN SITU). ARTG # 278615 - PART # KC-35020 - TIBIAL INSERT CONGRUENT CR, SZ 2, 10MM - LOT # 32966 (LEFT IN SITU). ARTG # 309120 - PART # KC-53000 - DOVETAIL TRAY CONNECTOR (LOCKING SCREW) - LOT # 27843 (LEFT IN SITU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623655 APEX KNEE SYSTEM CR FEMORAL UNCEMENTED JWH OMNILIFE SCIENCE INC. KC-1425R 35350

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H DOVETAIL TRAY CONNECTOR KC53000 LOT 27843| FEMUR KC-2202R LOT 31292| TIBIAL INSERT CR KC-35020 LOT 32966