MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY CEMENTED RIGHT S2

Model Number	02.07.1202R
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 july 2025.(b)(4) items manufactured and released on 28/01/2021.Expiration date: 18/01/2026.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation perfomed by clinical affairs department.4 years after primary cemented tka, the tibial tray subsides and needs replacement.The patient is overweight and the bone appears to be rather weak, with thin cortices.The failure is most probably due to the bone giving way, and it was not originated by a defect or malfunction of the implanted devices.
Event or Problem Description
4 years after the primary procedure, the patient reported pain caused by tibial component subsidence.The event was likely related to poor bone quality and excessive body weight.The surgeon revised all components using revision implants.The surgery was successfully completed.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY CEMENTED RIGHT S2
• 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: 22725446
• Report Number: 3005180920-2025-00756
• Device Sequence Number: 8288428
• Product Code: JWH
• UDI-Device Identifier: 07630030819872
• UDI-Public: 07630030819872
• 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: 2020
• 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): 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 Expiration Date: 01/18/2026
• Device Model Number: 02.07.1202R
• Device Lot Number: 2009467
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2021
• 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
• Patient Race: White