MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK 3D METAL TIBIAL TRAY; 3DMETAL TIBIAL TRAY SIZE T3I4R

Model Number	02.12.3D34R
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 july 2025.Gmk-sphere 02.12.3d34r gmk 3dmetal tibial tray size t3i4r (k221850) lot.2432770: (b)(4) items manufactured and released on 24-feb-2025.Expiration date: 06-feb-2030.No anomalies were 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.Additional component involved: gmk-sphere 02.12.E0411fr gmk-sphere tibial insert e-cross - flex 4r - 11mm (k202022) lot.2425473: (b)(4) items manufactured and released on 31-oct-2024.Expiration date: 15-oct-2029.No anomalies were 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.Conclusions: 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.
Event or Problem Description
Fourteen (14) days after the primary surgery, the patient reported instability and discomfort, with an unknown cause.The surgeon found the tibia to be soft and collapsed due to osteopenic bone.A tibial revision was performed, and the insert was upsized from 11mm to 14mm to address the instability.The surgery was successful.

• Brand Name: GMK 3D METAL TIBIAL TRAY
• Common Device Name: 3DMETAL TIBIAL TRAY SIZE T3I4R
• 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: 22727958
• Report Number: 3005180920-2025-00752
• Device Sequence Number: 21074786
• Product Code: JWH
• UDI-Device Identifier: 07630345710901
• UDI-Public: 07630345710901
• 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): 08/06/2025

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: 02.12.3D34R
• Device Lot Number: 2432770
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• 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: 71 YR
• Patient Sex: Female