MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; IXED TIBIAL TRAY CEMENTED RIGHT, SIZE 3

Model Number	02.07.1203R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 months after primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon removed all primary components and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 24-mar-2025: lot 2402347: (b)(4) items manufactured and released on 22-may-2024.Expiration date: 07-may-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.Additional devices revised: batch review performed on 24-mar-2025: 02.12.E003rp patella resurfacing size 3 e-cross (k202022) lot 2406165: (b)(4) items manufactured and released on 29-apr-2024.Expiration date: 11-apr-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.02.12.E0313fr tibial insert fixed sphere flex size 3/13 mm r e-cross (k202022) lot 2340906: (b)(4) items manufactured and released on 08-nov-2023.Expiration date: 17-oct-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.02.12.Ka13r femoral component spherika cemented s3+r (k121416) lot 2419527: (b)(4) items manufactured and released on 02-oct-2024.Expiration date: 18-sep-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.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.
Additional Manufacturer Narrative
Additional information: the spacer was removed on (b)(6) 2025 and permanent hardware was implanted.Gmk-revision system implanted.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: IXED TIBIAL TRAY CEMENTED RIGHT, SIZE 3
• 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: 21709058
• Report Number: 3005180920-2025-00238
• Device Sequence Number: 17307507
• Product Code: JWH
• UDI-Device Identifier: 07630030819896
• UDI-Public: 07630030819896
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 02.07.1203R
• Device Lot Number: 2402347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• 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: 79 YR
• Patient Sex: Female