MAUDE Adverse Event Report: Medacta International SA GMK 3D Metal Tibial Tray; GMK 3DMetal Tibial Tray Size 5L

Model Number	02.12.3D05L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary left knee surgery on (b)(6) 2026.On (b)(6) 2026, the patient had signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the flex 5l - 11mm insert to a same size insert.The surgery was completed successfully.On (b)(6) 2026, the patient continued to have signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the gmk 3dmetal tibial tray size 5l to a fixed tibial tray size 5 l - tinbn coating, revised the flex 5l - 11mm to a same size insert, and revised the porous tigrowthc+ha 5+l femoral component to a s5+l cemented tinbn femoral component.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 06 august 2026: 02.12.3d05l gmk 3dmetal tibial tray size 5l (k221850) lot.2501117: (b)(4) items manufactured and released on 04 april 2025.Expiration date: 16 march 2030.No anomalies found related to the problem.To date, 33 items of the same lot have been sold with no similar reported event during the period of review.02.12.E0511fl gmk-sphere tibial insert e-cross - flex 5l - 11mm (k202022) lot.2534818: (b)(4) items manufactured and released on 04 february 2026.Expiration date: 20 january 2031.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.02.12.Ka175l gmk spherika femur porous tigrowthc+ha size 5+l (k223548) lot.2424095: (b)(4) items manufactured and released on 13 december 2024.Expiration date: 27 november 2029.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:infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: GMK 3D Metal Tibial Tray
• Common Device Name: GMK 3DMetal Tibial Tray Size 5L
• 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: 50209599
• Report Number: 3005180920-2026-00856
• Device Sequence Number: 17672695
• Product Code: MBH
• UDI-Device Identifier: 07630345710857
• UDI-Public: 07630345710857
• Combination Product (Y/N): N
• PMA/510(K) Number: K221850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 02.12.3D05L
• Device Lot Number: 2501117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2025
• 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 Sex: Male