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

Model Number	02.09.0314H
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary left knee surgery on (b)(6) 2025.On (b)(6) 2025, the patient had pain due to an mcl injury.At about 1 year after the primary, the surgeon converted the patient from a sphere knee to a hinge knee by revising the tibial tray, insert and femoral component.The surgery was completed successfully.The hinge yoke screw was inserted using a manual medacta screwdriver and forced into place with a mallet instead of the prescribed 6 nm torque limiter.On (b)(6) 2026, the patient presented due to a gmk hinge yoke screw that had unscrewed, causing knee instability.The surgeon revised the liner, implanting a liner of the same size and screwed the yoke screw with the correct torque driver.No problems were detected on the other implants during the revision.
Additional Manufacturer Narrative
Preliminary analysis performed by r&d department: based on the available information, the yoke screw loosening appears to be related to a deviation from the recommended surgical technique.During the conversion from a sphere knee to a hinge knee, the hinge yoke screw was not tightened using the prescribed 6nm torque limiter, and therefore, the required torque may have not been achieved, resulting in insufficient preload.In addition, the screw was impacted with a mallet, which may have caused damage to the screw and/or housing threads, further compromising proper thread engagement.Insufficient tightening torque, possibly combined with thread damage, is considered the likely cause of the screw loosening.Batch review performed on (b)(6) 2026: lot 2343639: (b)(4) manufactured and released on 1-mar-2024.Expiration date: 2029-02-17.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Root cause: based on the available information, the mechanical cause of the yoke screw loosening is insufficient tightening torque, caused by the use of a manual screwdriver instead of the prescribed torque driver.The investigation did not identify any manufacturing-related issue or systemic deficiency.

• Brand Name: GMK HINGE TOTAL KNEE SYSTEM
• Common Device Name: GMK-HINGE TIBIAL INSERT - SIZE3 - 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: 24276573
• Report Number: 3005180920-2026-00065
• Device Sequence Number: 15595742
• Product Code: KRO
• UDI-Device Identifier: 07630030825132
• UDI-Public: 07630030825132
• Combination Product (Y/N): N
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/06/2026

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: 02.09.0314H
• Device Lot Number: 2343639
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2024
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White