BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4

    MDR report key: 19949041 · Received August 9, 2024

    Report

    Report Number
    3005180920-2024-00617
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 18, 2024
    Report Date
    August 9, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825835
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 JUL 2024. LOT 2246095: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2023. EXPIRATION DATE: 2028-02-09. 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 DEVICES INVOLVED IN THE EVENT: GMK-SPHERE 02.12.0412FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L (K121416) LOT 2238751: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2022. EXPIRATION DATE: 2027-10-30. 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. GMK-SPHERE 02.12.T3I4L TIBIAL TRAY FIXED CEMENTED SIZE T3I4 L (K121416) LOT 2245110: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAR-2023. EXPIRATION DATE: 2028-02-20. 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

    AT 1 YEAR AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS, WHICH WAS CAUSED BY ARTHROFIBROSIS. THE SURGEON REVISED THE FEMORAL COMPONENT, POLY AND TIBIAL INSERT, CONVERTING THE SPHERE KNEE TO A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661480 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 2246095 07630030825835

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention