BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 21010518 · Received December 24, 2024

    Report

    Report Number
    3005180920-2024-01118
    Event Type
    Injury
    Date Received
    December 24, 2024
    Date of Event
    December 10, 2024
    Report Date
    December 24, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17-DEC-2024. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-APR-2021. EXPIRATION DATE: 2026-04-07. 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. ADDITIONAL IMPLANTS REVISED: GMK-SPHERE 02.07.1206R TIBIAL TRAY FIXED CEMENTED SIZE 6 R (K090988) LOT. 2202646 BATCH REVIEW PERFORMED ON 17-DEC-2024 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2022. EXPIRATION DATE: 2027-05-26. 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. GMK-SPHERE 02.12.0610FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM R (K121416) LOT. 189065 BATCH REVIEW PERFORMED ON 17-DEC-2024 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2019. EXPIRATION DATE: 2024-02-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 4 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.07.0036RP PATELLA RESURFACING SIZE 4 (K113571) LOT. 2108184 BATCH REVIEW PERFORMED ON 17-DEC-2024 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-SEP-2021. EXPIRATION DATE: 2026-09-07. 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 AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1967048 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 R JWH MEDACTA INTERNATIONAL SA 02.12.0007R 2101915

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention