MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK 3D METAL TIBIAL TRAY; 3DMETAL TIBIAL TRAY SIZE 2R

Model Number	02.12.3D02R
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 jul 2025.Lot 2424253: (b)(4) items manufactured and released on 16-dec-2024.Expiration date: 2029-11-28.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.Clinical evaluation performed by medical affairs director.A few days after primary tka, the tibial bone gives way laterally and the baseplate subsides.According to the reported surgeon's comment, too small a baseplate was used, and the poor bone quality did not allow the construct to hold: we concur to this interpretation.A larger size was used at revision surgery and better cortical support was then achieved.No product defect originated this repetition of surgery.Conclusions: suboptimal size selection at the primary surgery and patient poor bone quality are likely the primary factors of this event.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.
Event or Problem Description
At 2 weeks from the primary, the patient came in due to pain that was identified by the surgeon to be caused by a collapsed tibia.Patient's bone quality was poor and tibial tray undersized implanted in primary.The surgeon upsized the insert and tibial baseplate to prevent repeat complications.The surgery was completed successfully.

• Brand Name: GMK 3D METAL TIBIAL TRAY
• Common Device Name: 3DMETAL TIBIAL TRAY SIZE 2R
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22792529
• Report Number: 3005180920-2025-00774
• Device Sequence Number: 8808703
• Product Code: JWH
• UDI-Device Identifier: 07630345710802
• UDI-Public: 07630345710802
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: 02.12.3D02R
• Device Lot Number: 2424253
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2024
• 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: Unknown