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

Model Number	02.12.3D02R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Loss of Range of Motion (2032)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain and stiffness in the knee due to a nickel sensitivity.About 7 months after the primary surgery, the surgeon revised all components to sensitin components.The surgery was completed successfully.Patient brought up nickel sensitivity to the doctor before primary but the surgeon was not concerned.Turned out patient did have nickel sensitivity and had to have all components revised.
Additional Manufacturer Narrative
Batch review performed on 20 june 2025.Gmk-spherika 02.12.3d02r gmk 3dmetal tibial tray size 2r (k221850) lot.2316458 lot 2316458: (b)(4) items manufactured and released on 25/10/2023.Expiration date: 09/10/2028.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.Additional items involved in the event: gmk-spherika 02.12.E0210fr gmk-sphere tibial insert e-cross - flex 2r - 10mm (k202022) lot.2412079 lot 2412079: (b)(4) items manufactured and released on 28/05/2024.Expiration date: 13/05/2029.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.Gmk-spherika 02.12.Ka163r gmk spherika femur porous tigrowthc+ha s3r (k223548) lot.2345362 lot 2345362: (b)(4) items manufactured and released on 17/06/2024.Expiration date: 28/05/2029.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.Root cause: the reported cause was nickel sensitivity with no alleged device deficiency or contributing factor, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: GMK 3D METAL TIBIAL TRAY
• Common Device Name: GMK 3DMETAL TIBIAL TRAY SIZE 2R
• 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: 22477460
• Report Number: 3005180920-2025-00655
• Device Sequence Number: 20943603
• Product Code: JWH
• UDI-Device Identifier: 07630345710802
• UDI-Public: 07630345710802
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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: 02.12.3D02R
• Device Lot Number: 2316458
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• 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: 52 YR
• Patient Sex: Female
• Patient Race: Black Or African American