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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 jan 2025: lot 2400362: (b)(4) items manufactured and released on 05-apr-2024.Expiration date: 2029-03-21.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.Preliminary investigation performed by r&d project manager: revision surgery of a gmk hinge tibial insert after few weeks from primary due to unscrewing of the hinge post screw.The hinge post screw was found loosened in the joint.Pictures of the explanted hinge post and relative secure screw have been sent for investigation.The hinge post secure screw looks damaged in its threaded shaft, with threads pressed and deformed.The usage of the torque limiting screwdriver, mandatory for this application, has been confirmed and we can suppose it was properly used.Cause for self unscrewing of the fixation screw is insufficient tightening torque.We can only suppose that the screw was not well in axis with the hinge post while tightening.In this condition, the torque screwdriver (mandatory for this application which usage has been confirmed) signals that the correct torque has been reached even though it has not and the possibility of a unscrewing becomes higher.From preliminary investigation there is no evidence that the event is related to a faulty device.Root cause: based on the available information, no definitive root cause can be confirmed.However, one possible mechanical explanation is insufficient tightening torque during the primary surgery, potentially caused by suboptimal screw alignment with the hinge post during tightening.The investigation does not indicate any potential manufacturing-related issue or systemic deficiency.
Event or Problem Description
Revision surgery due to gmk hinge post screw unscrewing and subsequent migration at 2 months after primary.It has been observed that the thread of the screw was damaged.Torque limiter was used.The surgeon revised the insert successfully.

• 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, 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: 21264315
• Report Number: 3005180920-2025-00017
• Device Sequence Number: 9475572
• Product Code: KRO
• UDI-Device Identifier: 07630030825132
• UDI-Public: 07630030825132
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 01/29/2025

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: 2400362
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2024
• 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 Sex: Female