BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 19573513 · Received June 20, 2024

    Report

    Report Number
    3005180920-2024-00427
    Event Type
    Injury
    Date Received
    June 20, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 20, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    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 27 MAY 2024 LOT 2247504: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2023. EXPIRATION DATE: 2028-03-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.0023L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L (K140826) LOT 2240979: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2023. EXPIRATION DATE: 2028-01-29. 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.E002RP PATELLA RESURFACING SIZE 2 E-CROSS (K202022) LOT 2248044: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2023. EXPIRATION DATE: 2028-03-27. 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.E0310FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L E-CROSS (K202022) LOT 2247344: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-FEB-2023. EXPIRATION DATE: 2028-02-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION DUE TO A KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 11 MONTHS POST PRIMARY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761831 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 2247504 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention