MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK 3D METAL TIBIAL TRAY; 3DMETAL TIBIAL TRAY SIZE 6L CEMENTLESS

Model Number	02.12.3D06L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 may 2026 gmk-sphere 02.12.1006l femoral component sphere cementless size 6 l lot: 2417770: (b)(4) items manufactured and released on 17-oct-2024.Expiration date: 2029-10-01.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.Gmk-sphere 02.12.3d06l 3dmetal tibial tray size 6l cementless (2527957) lot: 2527957: (b)(4) items manufactured and released on 07-jan-2026.Expiration date: 2030-12-12.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.Gmk-sphere 02.07.0310muc tibial insert uc mobile size 3 / 10 mm (k202022) lot: 2420979: (b)(4) items manufactured and released on 08-oct-2024.Expiration date: 2029-09-23.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation: the complaint describes an early post-operative infection following cementless total knee arthroplasty, diagnosed after the patient presented to the emergency department with fever.The available radiographic information does not show particular signs suggestive of infection.This does not exclude early infection, as radiographs may be normal in the early post-operative period.Based on the available information, the event is best classified as early post-operative periprosthetic joint infection requiring revision surgery.To date, there is no reason to suspect that the cause may be linked to the implanted devices.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.
Event or Problem Description
At about 1 month after the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised the femur, tibia and insert to semi-constraint.The surgery was completed successfully.

• Brand Name: GMK 3D METAL TIBIAL TRAY
• Common Device Name: 3DMETAL TIBIAL TRAY SIZE 6L CEMENTLESS
• 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: 25528745
• Report Number: 3005180920-2026-00541
• Device Sequence Number: 9744139
• Product Code: MBH
• UDI-Device Identifier: 07630345710871
• UDI-Public: 07630345710871
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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: 02.12.3D06L
• Device Lot Number: 2527957
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2026
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White