BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22506237 · Received July 15, 2025

    Report

    Report Number
    3005180920-2025-00660
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 15, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261600
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 JUNE 2025, LOT 2430458 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10/12/2024. EXPIRATION DATE: 25/11/2029. 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. ADDITIONAL DEVICES REVISED: GMK-SPHERE 02.12.E0312FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 12MM (K140826) LOT. 2430458. BATCH REVIEW PERFORMED ON 30 JUNE 2025. LOT 2418462: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29/08/2024. EXPIRATION DATE: 06/08/2029. 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 02.12.0023R FEMORAL COMPONENT SPHERE CEMENTED # 3+ R (K090988) LOT. 2418462 BATCH REVIEW PERFORMED ON 30 JUNE 2025. LOT 2431554: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03/03/2025. EXPIRATION DATE: 05/02/2030. 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. 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

    AFTER ONE MONTH FROM THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH SIGNS OF INFECTION. THE SURGEON REVISED ALL THREE COMPONENTS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771595 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 12MM JWH MEDACTA INTERNATIONAL SA 02.12.E0312FR 2430458 07630971261600

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown Required Intervention