MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL INSERT UC FIXED SIZE 4 / 12 MM

Model Number	02.07.0412FUC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After 12 years and 5 months from primary surgery, the patient reported knee instability.The surgeon upsized the liner from 12 mm to 17 mm, and the surgery was successfully completed.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: the insert was revised 12 years after the primary tka due to joint instability.A thicker polyethylene insert was implanted.The available x-ray image shows only that the interarticular space in full extension is wider in the left knee compared with the right knee (which also has a prosthesis).This type of late-onset instability is a well-recognized complication after tka.Over time, soft tissues may stretch or become lax, leading to insufficient ligamentous support.In such cases, replacing the insert with a thicker one to restore proper soft-tissue tension is a standard and appropriate management strategy.Importantly, this issue is not related to any implant defect or malfunction, but rather to the natural evolution of soft-tissue behavior over time following tka.Batch review performed on 18 nov 2025.Lot 124101: (b)(4) items manufactured and released on 31 oct 2017.Expiration date: 2028-09-18.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 the 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 PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT UC FIXED SIZE 4 / 12 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: 23669500
• Report Number: 3005180920-2025-01194
• Device Sequence Number: 9699718
• Product Code: JWH
• UDI-Device Identifier: 07630030817717
• UDI-Public: 07630030817717
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 11/28/2025

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: 10/31/2017
• Device Model Number: 02.07.0412FUC
• Device Lot Number: 124101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2012
• 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: Unknown