BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 21796990 · Received April 8, 2025

    Report

    Report Number
    3005180920-2025-00282
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 8, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 MARCH 2025 LOT 2116098: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2022. EXPIRATION DATE: 2026-12-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 21 MARCH 2025 GMK-SPHERE 02.12. E0410CRR TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM R (K202022) LOT 2112622: 25 ITEMS MANUFACTURED AND RELEASED ON 01-DEC-2021. EXPIRATION DATE: 2026-11-18. 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 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R (K090988) LOT 2005693: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-OCT-2020. EXPIRATION DATE: 2025-09-27. 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. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE 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 2 YEARS 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE SURGEON WAS NOT SATISFIED WITH THEIR ALIGNMENT FROM THE PRIMARY KNEE VARUS/VALGUS. THERE WERE NO ISSUES WITH THE PATIENT'S LIGAMENTS. THE SURGEON REVISED ALL COMPONENTS TO REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721340 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R JWH MEDACTA INTERNATIONAL SA 02.12.0024R 2116098

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention