MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; FLUTED EXTENSION STEM Ø18MM / L 105MM

Model Number	02.07.FCL18105
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
X-rays taken 8 years 7 months after the primary revealed that the extension stem screw connecting the femur and the offset was unscrewed and had migrated.The screw was removed through a small incision.The torque limiter was used during primary surgery.
Additional Manufacturer Narrative
Batch review performed on 30 mar 2026.Lot 167143: (b)(4) items manufactured and released on 01-feb-2017.Expiration date: 2022-jan-24.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.Clinical evaluation performed by medical affairs department.Approximately 9 years after a semi-constrained cemented tka, the femoral offset fixation screw was incidentally found loose within the joint during routine radiographic follow-up.The patient was asymptomatic at the time of detection.According to the surgical report, a torque-limiting screwdriver was used during the index procedure.Therefore, no clear and definitive root cause for the screw loosening can be established based on the available information.Insufficient tightening torque is the only mechanism that has been consistently associated with spontaneous screw back-out under controlled conditions.However, when a torque-limiting device is correctly used, this occurrence is considered highly unlikely, although it cannot be completely excluded.Other contributing factors, such as long-term mechanical loading, micro-movements at the interface, or multifactorial biomechanical conditions over time, may also have played a role, although no specific evidence is available in this case.Based on the available information, no evidence of a manufacturing defect or intrinsic device malfunction can be identified.The loose screw was removed through a minimally invasive procedure.It should be noted that the device is designed to function safely when all components are correctly assembled, including proper fixation of the offset with the screw.

• Brand Name: GMK REVISION TOTAL KNEE SYSTEM
• Common Device Name: FLUTED EXTENSION STEM Ø18MM / L 105MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 24924648
• Report Number: 3005180920-2026-00338
• Device Sequence Number: 9299147
• Product Code: JWH
• UDI-Device Identifier: 07630030823060
• UDI-Public: 07630030823060
• Combination Product (Y/N): N
• PMA/510(K) Number: K120790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2022
• Device Model Number: 02.07.FCL18105
• Device Lot Number: 167143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown