MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; FEMORAL COMPONENT CEMENTED STD SIZE 4 / LEFT

Model Number	02.07.2004L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Medical device site infection (4845)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
About 2 years and 10 months after the primary, the patient came in due to infection and the pathogen is unknown.All components revised to gmk-revision system.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 25 september 2025.Gmk-primary 02.07.2004l femoral component cemented std size 4 / left (k090988) lot 2203157: 18 items manufactured and released on 18-may-2022.Expiration date: 26-apr-2027.No anomalies found related to the problem.To date, 17 items of the same lot have been sold with no similar reported event during the period of review.Gmk-primary 02.07.1205l tibial tray fix cemented s.5l (k090988) lot 2200584: 30 items manufactured and released on 25-may-2022.Expiration date: 11-may-2027.No anomalies found related to the problem.To date, 30 items of the same lot have been sold with no similar reported event during the period of review.Gmk-primary 02.07.0512fuc tibial insert u.C.Fix s.5 / 12 mm (k090988) lot 1811654: 25 items manufactured and released on 21-may-2019.Expiration date: 07-may-2024.No anomalies found related to the problem.To date, 16 items of the same lot have been sold with no similar reported event during the period of review.Conclusions: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: FEMORAL COMPONENT CEMENTED STD SIZE 4 / LEFT
• 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: 23349013
• Report Number: 3005180920-2025-00989
• Device Sequence Number: 15820216
• Product Code: JWH
• UDI-Device Identifier: 07630030820212
• UDI-Public: 07630030820212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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: 02.07.2004L
• Device Lot Number: 2203157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2022
• 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 Sex: Male
• Patient Race: White