MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; FIXED TIBIAL INSERT SEMICONSTRAINED S.3 / 14 MM

Model Number	02.07.0314SCF
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	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the patient had primary right knee surgery with gmk-sphere components.On (b)(6) 2024, the patient came in reporting anterior pain and instability and the cause is unknown.The surgeon revised all components with revision components.The surgery was completed successfully mdr 2024-00690.On (b)(6) 2026, the patient came in reporting 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 mdr2025-00810.On (b)(6) 2026, the patient came in presenting limited range of motion with a stiff knee and the cause is unknown.The surgeon revised the 11mm insert to a 10mm insert and revised the 14mm peg to a 10mm peg.The surgery was completed successfully.Implanted - 02.07.0310scf insert semiconstrained 10mm s3 2523107 02.07.Scp10 tinbn coated sc peg - 10mm 2112334.
Additional Manufacturer Narrative
Batch review performed on 17 march 2026: gmk-revision 02.07.0314scf fixed tibial insert semiconstrained s.3 / 14 mm (k103170) lot 2346243: (b)(4) items manufactured and released on 16-feb-2024.Expiration date: 2029-jan-31.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.Scp14 tinbn coated sc peg - 14mm (k210010) lot 2414028: (b)(4) items manufactured and released on 05-jul-2024.Expiration date: 2029-jun-20.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: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: GMK REVISION TOTAL KNEE SYSTEM
• Common Device Name: FIXED TIBIAL INSERT SEMICONSTRAINED S.3 / 14 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: 24738826
• Report Number: 3005180920-2026-00270
• Device Sequence Number: 19963204
• Product Code: JWH
• UDI-Device Identifier: 07630030817298
• UDI-Public: 07630030817298
• 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): 03/31/2026

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 Model Number: 02.07.0314SCF
• Device Lot Number: 2346243
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2024
• 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