MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK 3D METAL TIBIAL TRAY; 3DMETAL TIBIAL TRAY SIZE T3I4L

Model Number	02.12.3D34L
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 february 2026.Lot 2518782: (b)(4) items manufactured and released on 24-sep-2025.Expiration date: 2030-09-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation.A revision surgery was performed approximately 3 month after the primary imlantation of a tka.The available x-ray images show a collapse of the lateral tibial hemiplateau, with subsequent displacement of the tibial tray and lateral subsidence.Such a condition may be multifactorial in origin.Contributing factors may include weakening of the tibial bone related to standard surgical bone preparation, patient-specific bone quality, and mechanical loading during the early rehabilitation phase, including potentially incongruous movements.Based on the available information, there is no evidence to suggest a device malfunction or a manufacturing defect.Visual inspection: the 3dmetal tibial tray was explanted three months after implantation due to the collapse of the lateral tibial hemiplateau.The explanted tibial tray presents a wide distal area with clear signs of osteointegration, extending to the most distal portion of the tibial keel.Some residual bone remains adherent to the anterior portion near the tibial keel, further suggesting integration of the device with the surrounding bone.On the bottom side, a small region located on the anterior side shows damage to the trabecular layer.The observed deformation is compatible with the use of a surgical tool during removal of the tibial tray from the bone during the explantation procedure.No other relevant findings were observed on the explanted tibial tray.Based on the analysis of the explanted device, there is no evidence to suggest that a device malfunction or defect contributed to the adverse event.Root cause: based on the available information, the collapse of the lateral tibial plateau appears to be multifactorial.Contributing factors likely include the patient¿s bone quality, standard surgical bone preparation, and mechanical loading during early rehabilitation, which may have included incongruous movements.While no systemic deficiency can be identified and the device history record review does not indicate any potential manufacturing-related issue, a definitive root cause cannot be conclusively established.
Event or Problem Description
At approximately 3 months from primary surgery, revision surgery was performed due to lateral tibial subsidence observed during follow-up.The patient was pain-free.The surgeon implanted a cemented plateau with two 5 mm shims and a 13 mm keel (65 mm length, 3 mm offset).The surgery was completed successfully.

• Brand Name: GMK 3D METAL TIBIAL TRAY
• Common Device Name: 3DMETAL TIBIAL TRAY SIZE T3I4L
• 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: 24558195
• Report Number: 3005180920-2026-00135
• Device Sequence Number: 18474247
• Product Code: MBH
• UDI-Device Identifier: 07630345710895
• UDI-Public: 07630345710895
• Combination Product (Y/N): N
• PMA/510(K) Number: K221850
• 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): 03/10/2026

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: 02.12.3D34L
• Device Lot Number: 2518782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White