MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE IMPLANTS; GMK-HINGE TIBIAL INSERT - SIZE4 - 14 MM

Model Number	02.09.0414H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to issues with range of motion and the cause is unknown.About 2 years and 6 months after the primary surgery, the surgeon determined a poly revision was required for flexion contracture of the knee.The surgeon revised the insert from 14mm to 12mm.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 13 october 2025 lot 2108842: (b)(4) items manufactured and released on 27-sep-2021.Expiration date: 06-sep-2026.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 mobility.There is no indication that any potential issue with the device may have caused or contributed to the event.

• Brand Name: GMK HINGE IMPLANTS
• Common Device Name: GMK-HINGE TIBIAL INSERT - SIZE4 - 14 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: 23461671
• Report Number: 3005180920-2025-01041
• Device Sequence Number: 21469229
• Product Code: KRO
• UDI-Device Identifier: 07630030825200
• UDI-Public: 07630030825200
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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: 09/06/2026
• Device Model Number: 02.09.0414H
• Device Lot Number: 2108842
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Race: White