MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; TIBIAL TRAY FIXED CEMENTED SIZE 4 R TINBN COATED

Model Number	02.07.2804R
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 may 2026 lot 2403137: (b)(4) items manufactured and released on 15-oct-2024.Expiration date: 2029-10-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation revision surgery was performed approximately 15 months after primary gmk-sphere tka due to persistent medial compartment pain.The most relevant reported findings are varus positioning of the tibial component and significant internal rotation of the tibial component, detected during revision surgery.Based on the available radiographic images, varus positioning of the tibial component can be confirmed.In addition, both the tibial and femoral components appear slightly undersized.A focal area of bone rarefaction is also visible at the medial femoral condyle; however, its significance cannot be determined on the basis of the available information.Overall, the combination of tibial component varus and internal rotation provides a plausible mechanical explanation for persistent medial compartment pain, through increased medial compartment loading, abnormal femorotibial tracking, and altered ligament balance.The available evidence is more suggestive of a surgery-/positioning-related mechanical problem than of a defective or malfunctioning device.Root cause:based on the information available, no definitive root cause can be established.The reported persistent medial compartment pain appears plausibly related to case-specific mechanical factors, in particular tibial component varus positioning and significant internal rotation, which may have contributed to increased medial compartment loading, abnormal femorotibial tracking, and altered ligament balance.
Event or Problem Description
Revision surgery due to persistent pain on medial compartment caused by significant internal rotation of tibial tray fixed cemented at 1 year 3 months from the primary.Gmk hinge system successfully implanted.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIXED CEMENTED SIZE 4 R TINBN COATED
• 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: 25230408
• Report Number: 3005180920-2026-00457
• Device Sequence Number: 10183949
• Product Code: JWH
• UDI-Device Identifier: 07630030821837
• UDI-Public: 07630030821837
• Combination Product (Y/N): N
• PMA/510(K) Number: K202684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/20/2026

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 Model Number: 02.07.2804R
• Device Lot Number: 2403137
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2024
• 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: 73 YR
• Patient Sex: Male