MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; FIXED TIBIAL INSERT SEMICONSTRAINED S.5 / 14 MM

Model Number	02.07.0514SCF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
8 months after the previous surgery, the patient presented with patellar tracking issues of unknown cause.The surgeon removed the competitor patient's patella and revised the medacta liner from 14 mm to 17 mm, probably due to knee instability.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 18 dec 2025.Lot 2208272: (b)(4) items manufactured and released on 07 june 2022.Expiration date: 19 may 2027.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: the surgeon revised liner height, which is a common practice to restore joint stability.There is no indication that any potential issue with the device may have caused or contributed to the event.

• Brand Name: GMK REVISION TOTAL KNEE SYSTEM
• Common Device Name: FIXED TIBIAL INSERT SEMICONSTRAINED S.5 / 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: 23858478
• Report Number: 3005180920-2025-01295
• Device Sequence Number: 13355795
• Product Code: JWH
• UDI-Device Identifier: 07630030818455
• UDI-Public: 07630030818455
• 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: 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): 12/19/2025

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: 02.07.0514SCF
• Device Lot Number: 2208272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Race: White