MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION/HINGE TOTAL KNEE SYSTEM; GMK-HINGE - UC TIBIAL INSERT - SIZE3 - 20 MM

Model Number	02.09.0320UCH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 march 2026: lot 2313168: (b)(4) items manufactured and released on 02-oct-2023.Expiration date: 2028-sep-17.No anomalies found related to the problem.To date, only the item of the complaint has been sold.Root cause:the surgeon revised liner height, which is a common practice to restore the joint stability.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
The patient had primary surgery with competitor implants.On (b)(6) 2024, the patient was revised to medacta gmk-hinge implants.On (b)(6) 2026, the patient came in presenting instability and the cause is unknown.There were no indications of trauma.The surgeon revised the gmk-hinge size 3 20mm insert to gmk-hinge size 3 23mm insert.The surgery was completed successfully.

• Brand Name: GMK-REVISION/HINGE TOTAL KNEE SYSTEM
• Common Device Name: GMK-HINGE - UC TIBIAL INSERT - SIZE3 - 20 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: 24711254
• Report Number: 3005180920-2026-00242
• Device Sequence Number: 5652442
• Product Code: KRO
• UDI-Device Identifier: 07630030879296
• UDI-Public: 07630030879296
• Combination Product (Y/N): N
• PMA/510(K) Number: K172347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/27/2026

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: 02.09.0320UCH
• Device Lot Number: 2313168
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2023
• 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: 57 YR
• Patient Sex: Female