BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

    MDR report key: 19664070 · Received July 3, 2024

    Report

    Report Number
    3005180920-2024-00416
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 4, 2024
    Report Date
    July 3, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    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 10 JUNE 2024 LOT 2318604: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2023. EXPIRATION DATE: 2028-09-26. 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 IMPLANTS INVOLVED: BATCH REVIEW PERFORMED ON 10 JUNE 2024: GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L (K121416) LOT 2336388: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-OCT-2023. EXPIRATION DATE: 2028-10-10. 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. E001RP PATELLA RESURFACING SIZE 1 E-CROSS (K202022) LOT 2318805: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2023. EXPIRATION DATE: 2028-10-03. 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. E0210FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L E-CROSS (K202022) LOT 2341892: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2023. EXPIRATION DATE: 2028-10-31. 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 ABOUT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526407 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 2318604 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention