MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK 3D METAL TIBIAL TRAY; GMK 3DMETAL TIBIAL TRAY SIZE 4L CEMENTLESS

Model Number	02.12.3D04L
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Joint Laxity (4526); Aseptic loosening (4883)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 february 2026.Gmk-spherika 02.12.3d04l gmk 3dmetal tibial tray size 4l cementless (k221850) lot: 2435208: (b)(4) items manufactured and released on 17-mar-2025.Expiration date: 26-feb-2030.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.Gmk-spherika 02.12.E0410fl gmk-sphere tibial insert e-cross - flex 4l - 10mm (k202022) lot: 2421779: (b)(4) items manufactured and released on 26-sep-2024.Expiration date: 12-sep-2029.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 patient details.Clinical evaluation.A revision surgery was performed approximately five months after primary total knee arthroplasty (tka) due to mobilization of the tibial component.The available x-ray imaging confirms loosening of the tibial component, radiographically evidenced by a slight elevation of its lateral aspect from the underlying bone, resulting in a medial tilt of the component.As a consequence, the knee appeared clinically unstable upon examination.Aseptic loosening is a known and literature-reported adverse event following primary tka, and its etiology is often multifactorial and not always clearly identifiable.Considering the relatively short time elapsed since the primary surgery, it is possible that adequate bone integration did not occur successfully in this case.However, based on the available clinical and radiological information, the root cause of the failure cannot be definitively determined.There is no evidence to suggest a defect or malfunction of the implanted prosthetic component.Root cause: the surgeon revised liner height, which is a common practice to restore the joint stability.Aseptic loosening is a known and literature-reported adverse event following primary tka, and its etiology is often multifactorial and not always clearly identifiable.Considering the relatively short time elapsed since the primary surgery, it is possible that adequate bone integration did not occur successfully in this case.However, based on the available clinical and radiological information, there is evidence of a slight elevation of the lateral aspect of the tibial component from the underlying bone, resulting in a medial tilt of the component.Consequently, the knee appeared clinically unstable upon examination.The root cause of the failure cannot be definitively determined.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.
Event or Problem Description
At about 5 months from the primary, during apost-operativeappointmentit was observed that the left knee components had shifted due to loosening of the tibial tray.The surgeon confirmed the knee was no longer balanced and stability was compromised.The tibial tray and femoral component were revised from a cementless to a cemented system, and the liner was upsized (from 10 mm to 13 mm) to improve stability.The surgery was completed successfully.

• Brand Name: GMK 3D METAL TIBIAL TRAY
• Common Device Name: GMK 3DMETAL TIBIAL TRAY SIZE 4L CEMENTLESS
• 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: 24343890
• Report Number: 3005180920-2026-00099
• Device Sequence Number: 10041454
• Product Code: MBH
• UDI-Device Identifier: 07630345710833
• UDI-Public: 07630345710833
• Combination Product (Y/N): N
• PMA/510(K) Number: K221850
• 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): 02/16/2026

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: 02.12.3D04L
• Device Lot Number: 2435208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2025
• 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