MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; FIXED TIBIAL INSERT SEMICONSTRAINED S.3 / 17 MM

Model Number	02.07.0317SCF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 08 august 2025: gmk-revision 02.07.0317scf fixed tibial insert semiconstrained s.3 / 17 mm (k103170) lot 2200918: (b)(4) items manufactured and released on 15-mar-2022.Expiration date: 2027-02-28.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-revision 02.07.Scp17 tinbn coated sc peg - 17mm (k210010) lot 2315191: (b)(4) items manufactured and released on 13-sep-2023.Expiration date: 2028-08-21.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.The surgeon downsized the liner, which is a common practice to restore the joint stiffness.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2024.On (b)(6) 2024, the patient had anterior pain and instability and the cause is unknown.The surgeon revised all components with revision components.The surgery was completed successfully.On (b)(6) 2025, the patient had stiffness and lack of range of motion and the cause is unknown.The surgeon downsized the poly to give the patient more range of motion.The surgery was completed successfully.

• Brand Name: GMK REVISION TOTAL KNEE SYSTEM
• Common Device Name: FIXED TIBIAL INSERT SEMICONSTRAINED S.3 / 17 MM
• 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: 22949880
• Report Number: 3005180920-2025-00810
• Device Sequence Number: 18207748
• Product Code: JWH
• UDI-Device Identifier: 07630030817410
• UDI-Public: 07630030817410
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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 Model Number: 02.07.0317SCF
• Device Lot Number: 2200918
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2022
• 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: Female