MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; FIXED TIBIAL TRAY CEMENTED LEFT, SIZE 4

Model Number	02.07.1204L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 june 2025.Lot 1908631: (b)(4) items manufactured and released on 16-march-2020.Expiration date: 2025-03-05.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Additional component revised: gmk-sphere 02.12.0411fl tibial insert fixed sphere flex size 4/11 mm l (k140826) lot 2000400: (b)(4) items manufactured and released on 25-feb-2020.Expiration date: 2025-02-08.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.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
At about 1 year 10 months after the primary, the patient came in reporting pain and the cause is unknown.The surgeon revised the tibial tray and insert and implanted a tibial cone and extension stem.The surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: FIXED TIBIAL TRAY CEMENTED LEFT, SIZE 4
• 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: 22384187
• Report Number: 3005180920-2025-00646
• Device Sequence Number: 8663547
• Product Code: JWH
• UDI-Device Identifier: 07630030819902
• UDI-Public: 07630030819902
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 07/02/2025

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 Expiration Date: 03/05/2025
• Device Model Number: 02.07.1204L
• Device Lot Number: 1908631
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2020
• 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: 70 YR
• Patient Sex: Male
• Patient Race: White