BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R

    MDR report key: 17181878 · Received June 22, 2023

    Report

    Report Number
    3005180920-2023-00432
    Event Type
    Injury
    Date Received
    June 22, 2023
    Date of Event
    May 23, 2023
    Report Date
    June 22, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819896
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 MAY 2023 LOT 2102506: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAY-2021. EXPIRATION DATE: 2026-APR-(B)(4). NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 1,5 YEARS AFTER PRIMARY CEMENTED TKA THE PATIENT IS IN PAIN AND THE SURGEON DIAGNOSED METAL HYPERSENSITIVITY, ACCORDING TO A REASONABLE INTERPRETATION OF THE REPORT. THEREFORE, HE DECIDED TO CHANGE THE METAL IMPLANTS TO A CERAMIC COATED VERSION, IN ORDER TO REDUCE THE ION RELEASE THAT MAY TRIGGER THE HYPERSENSITIVITY REACTION. THE PRIMARY PROSTHESIS LOOKS CORRECTLY IMPLANTED AND THERE IS NO REASON TO SUSPECT A FAULTY OR DEFECTIVE DEVICE; THE POSSIBILITY OF HYPERSENSITIVITY REACTION IS LISTED AMONG THE POTENTIAL SOURCES OF ADVERSE EVENTS IN THE PRODUCT LITERATURE, BUT IT IS KNOWN THAT IT IS SOMETIMES DIFFICULT TO VERIFY IN ADVANCE AND THEN IT CAN INTERVENE SECONDARILY. IT OUGHT TO BE NOTED THAT THE SURGEON OPTED FOR A MORE CONSTRAINED DEVICE FOR THE REVISION OPERATION, BUT THE REASONS FOR THIS CHOICE ARE NOT SPECIFIED IN THE REPORT. OTHER DEVICE INVOLVED: GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R (K121416) LOT 2001647: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUN-2020. EXPIRATION DATE: 2025-JUN-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A NICKEL ALLERGY AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS TO HINGE SENSITIN COMPONENTS AND RESURFACED THE PATIENT'S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72140 GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1203R 2102506 07630030819896

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention