MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; GMK-HINGE EXTENSION STEM - FLUTED Ø 13 L 150

Model Number	02.07.FCL13150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
About 6 and a half years after the primary surgery, the patient came in reporting pain after falling and fracturing her ankle.It was also observed from the x-rays that the femoral stem broke at the time of the fall.The surgeon took all of the femoral implants out and put in new implants.The surgery was completed successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by madacta clinical affairs department: about 6.5 years after revision tka in an extremely heavy patient with very bad bone condition, almost certainly resulting from multiple previous surgeries (unreported), a traumatic event causes the fracture of the femoral extension stem, and the femoral part of the implant needs revision.Several conditions that may shorten the active life of the implant, as described in the instructions for use, are simultaneously present in this case: the extremely high mass of the patient, the very thick insert that causes an increase in the lever arm against the femoral stem, the addition of tibial wedges and cones to make for the missing bone, the lack of femoral bone surrounding the junction between stem and component - thus reducing the necessary complementary support, and finally a traumatic event.Under these very unfavourable circumstances, the probability that a traumatic event may cause the fracture of the implant is, of course, increased, and that is what happened, most likely.R&d investigation performed by medacta knee r&d project manager: six and a half years after a revision total knee arthroplasty (tka) in a heavy patient with compromised bone quality, a traumatic event led to the fracture of the femoral extension stem, necessitating revision of the femoral component.Images of the explanted devices show that the extension stem fractured at the level of the female taper connection, which is designed to couple with the femoral component.The images also reveal the explanted tibial insert along with its fixation screw, which is intended to secure the insert to the tibial tray.Closer examination of the extension stem indicates the absence of the fixation screw that serves as a secondary element to reinforce the morse taper connection.In case of fracture at the taper interface, this fixation screw would also be expected to fracture.However, no remaining threaded portion of the screw is visible within the stem.Furthermore, the agent confirmed that the only recovered screw was the one for the tibial insert.This suggests that the fixation screw for the femoral stem may not have been used at the time of the primary implantation.The absence of this secondary fixation component could have adversely affected the mechanical stability of the morse taper connection.Based on the available information, there is no evidence to suggest that this event was caused by a faulty device.Batch review performed on 8 may 2025: lot 162540: (b)(4) items manufactured and released on 15/09/2016.Expiration date: 2021/08/29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold (considering also resterilized products) with no similar reported event during the period of review.

• Brand Name: GMK REVISION TOTAL KNEE SYSTEM
• Common Device Name: GMK-HINGE EXTENSION STEM - FLUTED Ø 13 L 150
• 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: 22121867
• Report Number: 3005180920-2025-00504
• Device Sequence Number: 12556658
• Product Code: JWH
• UDI-Device Identifier: 07630030822957
• UDI-Public: 07630030822957
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K120790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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: 08/29/2021
• Device Model Number: 02.07.FCL13150
• Device Lot Number: 162540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2025
• Initial Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 179 KG
• Patient Race: Black Or African American