MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIX CEMENTED S.1L

Model Number	02.07.1201L
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
6 months after the primary surgery, the patient presented with pain due to collapse of the lateral tibial bone.During the primary surgery, the tibial component had been slightly undersized, and the patient had soft bone.The surgeon revised the tibial tray and insert, and implanted a stem extension along with tibial augments.The revision surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2025.Lot 2316126: 24 items manufactured and released on (b)(6) 2023.Expiration date:(b)(6) 2028.No anomalies found related to the problem.To date, 12 items of the same lot have been sold with no similar reported event during the period of review.Root cause: based on the available information, the collapse of the lateral tibial bone appears to be related to the combination of an undersized tibial component and poor bone quality observed during the primary surgery.While no systemic deficiency can be identified and the device history record review does not indicate any potential manufacturing-related issue, a definitive root cause cannot be conclusively established.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIX CEMENTED S.1L
• 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: 22673493
• Report Number: 3005180920-2025-00729
• Device Sequence Number: 3715902
• Product Code: JWH
• UDI-Device Identifier: 07630030819841
• UDI-Public: 07630030819841
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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: 02.07.1201L
• Device Lot Number: 2316126
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• 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: Female