BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TOTAL KNEE SYSTEM

    MDR report key: 20756806 · Received November 22, 2024

    Report

    Report Number
    3005180920-2024-00973
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    October 29, 2024
    Report Date
    November 22, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040711593
    PMA / PMN Number
    K202684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-NOV-2024: LOT 2247645: 18 ITEMS MANUFACTURED AND RELEASED ON 12-APR-2023. EXPIRATION DATE: 2028-03-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS REVISED, BATCH REVIEW PERFORMED ON 20-NOV-2024: GMK-SPHERE 02.12.E003RP PATELLA RESURFACING SIZE 3 E-CROSS (K202022) LOT 2314117: 55 ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2023. EXPIRATION DATE: 2028-09-24. 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. GMK-SPHERE 02.12.E0511FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R (K202022) LOT 2314696: 50 ITEMS MANUFACTURED AND RELEASED ON 02-AUG-2023. EXPIRATION DATE: 2028-07-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 26 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.07.2805R TIBIAL TRAY FIXED CEMENTED SIZE 5 R TINBN COATED (K202684) LOT 2245298: 24 ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2023. EXPIRATION DATE: 2028-04-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 10 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL GMK-SPHERE COMPONENTS WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852836 GMK TOTAL KNEE SYSTEM FEMORAL COMPONENT SPHERE SIZE 5+ R TINBN COATED JWH MEDACTA INTERNATIONAL SA 02.12.0725R 2247645 07630040711593

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention