MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; FIXED TIBIAL INSERT SEMICONSTRAINED S.2 / 17 MM

Model Number	02.07.0217SCF
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	01/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 2 february 2026.Gmk-revision 02.07.0217scf fixed tibial insert semiconstrained s.2 / 17 mm (k103170) lot 2103938: (b)(4) items manufactured and released on 05-may-2021.Expiration date: 21-apr-2026.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 2412008: (b)(4) items manufactured and released on 09-jul-2024.Expiration date: 20-jun-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.Root cause: the surgeon revised liner height, which is a common practice to restore the joint mobility.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 primary surgery utilizing competitor implants.On (b)(6) 2025, the patient came in reporting pain due to a loose femur and the cause is unknown.The surgeon revised the insert, femur, post, stems, and augments.The surgery was completed successfully.Presently, on (b)(6) 2026, the patient came in reporting a stiff knee and the cause is unknown.The surgeon downsized the insert and tinbn peg from 17mm to 12mm to improve movement.The surgery was completed successfully.

• Brand Name: GMK REVISION TOTAL KNEE SYSTEM
• Common Device Name: FIXED TIBIAL INSERT SEMICONSTRAINED S.2 / 17 MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24376292
• Report Number: 3005180920-2026-00112
• Device Sequence Number: 14845803
• Product Code: JWH
• UDI-Device Identifier: 07630030816833
• UDI-Public: 07630030816833
• Combination Product (Y/N): N
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: 04/21/2026
• Device Model Number: 02.07.0217SCF
• Device Lot Number: 2103938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• 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