MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE TOTAL KNEE SYSTEM; GMK-HINGE 02.09.4003L FIXED TIBIAL TRAY SIZE 3 L

Model Number	02.09.4003L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 10 months from the primary, the patient came in reporting pain due to a malpositioned tibia and the cause is unknown.The surgeon revised the tibia and liner the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 31 march 2025.Lot 184353: (b)(4) items manufactured and released on 24-jul-2018.Expiration date: 2023-07-10.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by r&d project manager.Two years after a complex tkr revision case, the tibia becomes painful and a surgeon different from the previous one performs a partial exchange of the system, replacing baseplate and insert.The information supplied, as well as the imaging, is not sufficient to assess the situation.According to report, the tibia was malpositioned, but this is a gross statement that we cannot easily confirm with the one image supplied.Also, no radiographic history is available, and therefore the analysis is incomplete.However, we see no reason to suspect that a defect or malfunction of the implanted devices caused the problem.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: GMK HINGE TOTAL KNEE SYSTEM
• Common Device Name: GMK-HINGE 02.09.4003L FIXED TIBIAL TRAY SIZE 3 L
• 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: 21907227
• Report Number: 3005180920-2025-00306
• Device Sequence Number: 4085102
• Product Code: KRO
• UDI-Device Identifier: 07630030825552
• UDI-Public: 07630030825552
• 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: 2023
• 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): 04/25/2025

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: 07/10/2023
• Device Model Number: 02.09.4003L
• Device Lot Number: 184353
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2018
• 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 Sex: Unknown