BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23036822 · Received September 12, 2025

    Report

    Report Number
    3005180920-2025-00852
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 18, 2025
    Report Date
    September 12, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261877
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25-AUG-2025: 02.12.E0413FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 13MM (K202022) LOT. 2242240: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-07-2023 EXPIRATION DATE: 2028-06-25. 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. 02.07.1204L TIBIAL TRAY FIX CEMENTED S.4L (K090988) LOT. 2305869: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-01-2023 EXPIRATION DATE: 2027-11-29. 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. 02.12.0025L GMK-SPHERE FEMORAL COMPONENT CEMENTED - 5+L (K140826) LOT. 2305319: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-06-2023 EXPIRATION DATE: 2028-05-21. 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. 02.07.0036RP RESURFACING PATELLA SIZE 4 (K113571) LOT. 2307827: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-06-2023 EXPIRATION DATE: 2028-06-11. 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. CONCLUSIONS: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 10 MONTHS THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2676273 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 13MM JWH MEDACTA INTERNATIONAL SA 02.12.E0413FL 2242240 07630971261877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention