MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE TOTAL KNEE SYSTEM; GMK-HINGE 02.09.0314H GMK-HINGE TIBIAL INSERT - SIZE3 - 14 MM

Model Number	02.09.0314H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17-02-2025 lot 2247581: (b)(4) items manufactured and released on 09-03-2023.Expiration date: 2028-02-20.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.Other devices involved: batch review performed on 17-02-2025 gmk-hinge 02.09.2704l gmk-hinge femoral component size4 l - tinbn coated (k210010) lot 2311769: (b)(4) items manufactured and released on 22-11-2023.Expiration date: 2028-10-31.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.Due to the lack of information, it is not possible to establish a definitive root cause, while the device history record review does not indicate any potentially related manufacturing issue.
Event or Problem Description
At about 6 months from primary, the patient came in reporting pain and the cause is unknown.The surgeon revised the femoral component and insert.The surgery was completed successfully.

• Brand Name: GMK HINGE TOTAL KNEE SYSTEM
• Common Device Name: GMK-HINGE 02.09.0314H GMK-HINGE TIBIAL INSERT - SIZE3 - 14 MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21574226
• Report Number: 3005180920-2025-00150
• Device Sequence Number: 15521761
• Product Code: KRO
• UDI-Device Identifier: 07630030825132
• UDI-Public: 07630030825132
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

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: 02.09.0314H
• Device Lot Number: 2247581
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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