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

Model Number	02.12.3D03L
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 5 weeks from the primary, the patient came in presenting pain due to a tibial tray that collapsed into the valgus.Bone was very soft with significant resorption on the lateral tibial plateau.During primary surgery, the surgeon assessed the bone quality and initially felt that a primary press-fit knee implant would be appropriate despite the patient`s high bmi and age.The surgeon revised the gmk 3dmetal tibial tray size 3l to a rev.Tibial tray s3 along with tibial cones and augments, and revised the 11mm insert to a 12mm one.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 07 may 2026 lot 2526441: (b)(4) items manufactured and released on 01-dec-2025.Expiration date: 2030-nov-18.No anomalies found related to the problem.To date, 36 items of the same lot have been sold with no similar reported events during the period of review.Root cause:based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: GMK 3D METAL TIBIAL TRAY
• Common Device Name: GMK 3DMETAL TIBIAL TRAY SIZE 3L 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: 25268620
• Report Number: 3005180920-2026-00470
• Device Sequence Number: 9185537
• Product Code: MBH
• UDI-Device Identifier: 07630345710819
• UDI-Public: 07630345710819
• 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): 05/25/2026

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: 02.12.3D03L
• Device Lot Number: 2526441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2025
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Race: White