MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK FIXED TIBIAL TRAY CEMENTED SIZE 4 RIGHT

Model Number	02.07.1204R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager: the case concerns revision of a right gmk-sphere total knee arthroplasty approximately five years after primary implantation, in the context of medial subsidence of the tibial tray.According to the reporting hospital, the observed subsidence was attributed to aseptic loosening of the tibial component.This interpretation is clinically plausible and consistent with the available radiographic findings; however, the event may be multifactorial in origin.The radiograph also suggests possible medial femoral bone rarefaction or reduced bone density, the clinical significance of which cannot be determined based on the available information.Based on the information currently available, a definitive root cause cannot be established.There is no direct evidence indicating a device-related defect or malfunction.Batch review performed on 22 april 2026: lot 2004706: (b)(4) items manufactured and released on 31-aug-2020.Expiration date: 2025-aug-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events since release into the market.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.
Event or Problem Description
The patient reported pain and instability.Revision surgery was performed about 5 years after the primary surgery due to tibial loosening and subsidence on the medial side, fully detached from the cement mantle.Femoral component cementless showed bone resorption at the medial distal cut and at the superior chamfer.Because the tibial plateau could not be easily exposed for a partial revision, and given the resorption at the femoral component, it was decided to revise the entire prosthesis.All components revised and surgery completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK FIXED TIBIAL TRAY CEMENTED SIZE 4 RIGHT
• 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: 25039773
• Report Number: 3005180920-2026-00399
• Device Sequence Number: 10411053
• Product Code: JWH
• UDI-Device Identifier: 07630030819919
• UDI-Public: 07630030819919
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/30/2026

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: 08/23/2025
• Device Model Number: 02.07.1204R
• Device Lot Number: 2004706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• 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 Age: 72 YR
• Patient Sex: Male