BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20735104 · Received November 20, 2024

    Report

    Report Number
    3005180920-2024-00972
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    October 22, 2024
    Report Date
    December 9, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825842
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVING THE COMPLAINT RELATED TO MDR (B)(4) THAT IS ASSOCIATED TO THIS COMPLAINT (MDR (B)(4)) THE PATIENT'S INFORMATION GENDER AND DATE OF BIRTH WERE REPORTED. THE COMPLAINT RELATED TO MDR (B)(4) WAS REPORTED ON NOVEMBER 23RD 2024. THE SECTION A2 AND A3A WERE UPDATED.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 NOVEMBER 2024: LOT 2246097: 103 ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2023. EXPIRATION DATE: 2028-02-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED AND REVISED: GMK-SPHERE 02.12. E0410CRR TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM R (K202022) LOT 2116995: (B)(4) MANUFACTURED AND RELEASED ON 12-JAN-2022. EXPIRATION DATE: 2026-12-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3I4 R (K121416) LOT 2242813: (B)(4) MANUFACTURED AND RELEASED ON 17-FEB-2023. EXPIRATION DATE: 2028-02-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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

    REVISION DUE TO OF INFECTION AT ABOUT 1 YEAR AND 6 MONTHS POST PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND IMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2461225 GMK SPHERE TOTAL KNEE SYSTEM FEMUR SPHERE CEMENTED RIGHT SIZE 4 JWH MEDACTA INTERNATIONAL SA 02.12.0004R 2246097 07630030825842

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention