MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK 3D METAL TIBIAL TRAY

Model Number	02.12.3D02L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-apr-2025: lot 2109756: (b)(4) manufactured and released on 03-11-2021.Expiration date: 2026-10-20.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.Clinical evaluation performed by clinical affairs department: 2 months after primary tka with inverse-hybrid fixation (cemented femur, cementless tibia), the lateral tibia bone gives way and the baseplate falls in valgus.A small radiopaque formation on the postoperative xray is visible just above the fibula, which may have deceived the surgeon during implantation, looking as cortical tibia while it was something different, so that a suboptimal contact between lateral tibia plateau and baseplate was obtained, which resulted in the subsequent loss of stability.No reason to suspect that the adverse event was caused by a defective or malfunctioning device.Visual inspection performed by r&d department: approximately two months following a primary cementless total knee arthroplasty (tka), macroscopic subsidence of the tibial tray was observed on the medial side, necessitating revision surgery.Findings from explanted tibial tray examination: the distal surface of the tibial tray showed areas with residual bone attachment, indicating some degree of osseointegration.A small antero-medial region exhibited damage to the trabecular layer, with a pattern consistent with mechanical impact likely caused by a surgical tool during explantation.No other relevant abnormalities, material defects, or damage were observed on the tibial tray.Based on the analysis, there is no evidence suggesting a device fault contributed to the observed subsidence.Findings from explanted tibial insert examination: the articular surface displayed some scratches, likely produced during attempts to remove the insert from the tibial tray during the revision procedure.No other relevant abnormalities or signs of premature wear were identified on the tibial insert.The analysis of the explanted components does not indicate any material or design faults in the tibial tray or insert.The adverse event (medial subsidence) appears unrelated to device performance.
Event or Problem Description
At about 2 months from primary the patient noticed a valgisation of the cementless tibial implant.Follow-up visti with x-ray showed a depression of the lateral tibial plateau.On the same day of the visit the surgeon revised the tibial base with gmk primary with shims and pins.

• Brand Name: GMK 3D METAL TIBIAL TRAY
• Common Device Name: GMK 3D METAL TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21974611
• Report Number: 3005180920-2025-00340
• Device Sequence Number: 9188182
• Product Code: JWH
• UDI-Device Identifier: 07630345710796
• UDI-Public: 07630345710796
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K221850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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: 02.12.3D02L
• Device Lot Number: 2403082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White