BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ L

    MDR report key: 14927427 · Received July 6, 2022

    Report

    Report Number
    3005180920-2022-00511
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    June 8, 2022
    Report Date
    July 6, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862472
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 JUNE 2022: LOT 2100349: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2021. EXPIRATION DATE: 2026-MAR-14. 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. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 10 JUNE 2022: GMK-SPHERE 02.12.E0111FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/11 MM L E-CROSS (K202022) LOT 2002462: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-DEC-2020. EXPIRATION DATE: 2025-NOV-17. 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 STIFFNESS IN THE KNEE AND THE CAUSE IS UNKNOWN. AT ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. FEMUR WAS REVISED BECAUSE THE SURGEON THOUGHT THE PATIENT FELL INTO THE VALGUS PHENOTYPE AND WANTED TO USE A SPHERIKA FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430038 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ L KNEE CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 02.12.0022L 2100349 07630030862472

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention