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

Model Number	02.12.3D05L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to 3d metal cemented tibial tray loosening after about 8 months from primary.The surgeon revised the gmk 3dmetal tibial tray size 5l to a gmk tibial tray cemented left s4 and revised the gmk-sphere tibial insert e-cross - flex 5l - 10mm to a gmk-sphere tibial insert e-cross - flex 4l - 14mm.
Additional Manufacturer Narrative
Batch review performed on 29 july 2026 lot.2507354: (b)(4) items manufactured and released on 18-jun-2025.Expiration date: 2030-jun-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Root cause:implant mobilization 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 cemented
• 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: 50222761
• Report Number: 3005180920-2026-00833
• Device Sequence Number: 10336745
• 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: 2025
• 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): 08/12/2026

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: 2507354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2025
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 270 LB
• Patient Race: White