MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL INSERT U.C. FIX S.3 / 12 MM

Model Number	02.07.0312FUC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 nov 2025 gmk-primary 02.07.0312fuc tibial insert u.C.Fix s.3 / 12 mm lot.186264: (b)(4) items manufactured and released on 13 nov 2018.Expiration date: 01 nov 2023.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 stability, and resurfaced the patient's natural patella, which is a common practice in case of not patella resurfacing during primary surgery.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
On (b)(6) 2015, the patient underwent primary knee surgery.On (b)(6) 2017, after a fall, the patient presented with laxity, and the 12 mm insert was revised to a 17 mm insert.On (b)(6) 2017, following another fall and recurrent laxity, the insert was revised from 17 mm to 20 mm.On (b)(6) 2022, the patient presented with instability of unknown cause, and the surgeon revised the insert and tibial tray (b)(4).On (b)(6) 2025, the patient presented with anterior knee pain and laxity of unknown cause, and the surgeon revised the insert (from 12 mm to 14mm) and resurfaced the patella.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT U.C. FIX S.3 / 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: 23690784
• Report Number: 3005180920-2025-01217
• Device Sequence Number: 10192294
• Product Code: JWH
• UDI-Device Identifier: 07630030817137
• UDI-Public: 07630030817137
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/02/2025

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: 11/01/2023
• Device Model Number: 02.07.0312FUC
• Device Lot Number: 186264
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2018
• 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 Age: 63 YR
• Patient Sex: Female