BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 24738819 · Received March 31, 2026

    Report

    Report Number
    3005180920-2026-00301
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    March 13, 2026
    Report Date
    March 31, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262041
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 MARCH 2026. GMK-SPHERE 02.12.E0511FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 11MM (K202022) LOT 2242960: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 04-DEC-2027. 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 02.12.0025R GMK-SPHERE FEMORAL COMPONENT CEMENTED - 5+R (K140826) LOT 2245094: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2023. EXPIRATION DATE: 26-JAN-2028. 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 02.07.1205R TIBIAL TRAY FIX CEMENTED S.5R (K090988) LOT 2242048: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2023. EXPIRATION DATE: 16-JAN-2028. 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. ROOT CAUSE: 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 2 YEARS AND 9MONTHS FROM THE PRIMARY,THE PATIENT CAME IN DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGERY REVISED THE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT AND IMPLANTED ANTIBIOTIC SPACERS TO TREAT THE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803016 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 11MM JWH MEDACTA INTERNATIONAL SA 02.12.E0511FR 2242960 07630971262041

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention