MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIX CEMENTED S.5L

Model Number	02.07.1205L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At 5 years and 6 months from the primary procedure, the patient came in presenting pain and instability that began during physical therapy.The patient reported injuring the knee during a physical therapy session and stated that pain persisted following the incident.Preoperative x-rays suggested loosening of the components.Intraoperatively, all components were confirmed to be loose, with significant medial femoral bone loss observed.The surgeon revised the gmk-sphere femur, insert, and tibial tray to a gmk-hinge system.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 22 apr 2026 lot 1908641: (b)(4) items manufactured and released on 26/03/2020.Expiration date: 19/03/2025.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.Lot 1904602: (b)(4) items manufactured and released on 25/09/2019.Expiration date: 15/09/2024.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 clinical affairs department this case describes a late failure of a cemented total knee arthroplasty approximately 5.5 years after implantation, presenting with pain and instability and requiring full revision to a hinged system.Radiographic findings, although limited due to poor image quality, suggest the presence of radiolucent lines around the tibial component.These findings are compatible with loosening of the tibial component and correlate with the intraoperative observation of global implant loosening.Aseptic loosening represents the most likely mechanism; however, the exact root cause cannot be determined based on the available information, as it is often difficult to identify and is generally multifactorial.There is no evidence to suggest a device-related defect or malfunction.Root cause: 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.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIX CEMENTED S.5L
• 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: 25160333
• Report Number: 3005180920-2026-00418
• Device Sequence Number: 10642551
• Product Code: JWH
• UDI-Device Identifier: 07630030819926
• UDI-Public: 07630030819926
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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 Expiration Date: 03/19/2025
• Device Model Number: 02.07.1205L
• Device Lot Number: 1908641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• 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: Male
• Patient Race: White