MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK 3D METAL TIBIAL TRAY; GMK 3DMETAL TIBIAL TRAY SIZE 2R CEMENTLESS

Model Number	02.12.3D02R
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 9 january 2026.Gmk-spherika 02.12.3d02r gmk 3dmetal tibial tray size 2r cementless (k221850) lot 2503524: (b)(4) items manufactured and released on 25-apr-2025.Expiration date: 10-apr-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.Clinical evaluation: a revision surgery was performed approximately four months after the primary tka implantation.The patient returned for evaluation complaining of joint instability.The available postoperative x-ray images show slight undersizing of the tibial tray.This finding may be considered among the contributing factors to the subsidence observed on the pre-revision radiographic images, with subsequent component mobilization, as suggested by the presence of radiolucent lines around the implant.This condition may explain the symptoms reported by the patient.Based on the available information, there are no elements to suggest a defective or malfunctioning device.Root cause:aseptic loosening is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.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 4 months from the primary, the patient came in due to instability as the result of tibial loosening and the cause is unknown.The surgeon revised the tibial tray from gmk 3d metal 2r cementless to a gmk cemented s2 and upsized the insert from 12mm to 17mm.The surgery was completed successfully.

• Brand Name: GMK 3D METAL TIBIAL TRAY
• Common Device Name: GMK 3DMETAL TIBIAL TRAY SIZE 2R 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: 24162767
• Report Number: 3005180920-2026-00045
• Device Sequence Number: 15794956
• Product Code: MBH
• UDI-Device Identifier: 07630345710802
• UDI-Public: 07630345710802
• 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): 01/23/2026

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: 02.12.3D02R
• Device Lot Number: 2503524
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2025
• 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: 68 YR
• Patient Sex: Female
• Patient Race: White