MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; FIXED TIBIAL INSERT SC SIZE 6/20MM

Model Number	02.07.0620SCF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After 2 years and 8 months from the primary procedure, the patient presented with pain and instability of unknown origin.The surgeon upsized the liner (from 20mm to 26mm) to improve joint stability and resurfaced the patella.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 dec 2025.Gmk-revision 02.07.0620scf fixed tibial insert sc size 6/20mm lot.Insert semiconstrained 20mm s6 sn (b)(6): (b)(4) items manufactured and released on 25 -oct-2018.Expiration date: 11-10-2023.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events 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 SC SIZE 6/20MM
• 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: 23838628
• Report Number: 3005180920-2025-01267
• Device Sequence Number: 9958330
• Product Code: JWH
• UDI-Device Identifier: 07630030819254
• UDI-Public: 07630030819254
• Combination Product (Y/N): N
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 12/18/2025

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 Expiration Date: 11/10/2023
• Device Model Number: 02.07.0620SCF
• Device Lot Number: 187621
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2018
• 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: Male