MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; KNEE PATELLA RESURFACING

Model Number	02.07.0036RP
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 october 2024.Gmk-revision 02.07.0036rp patella resurfacing size 4 lot 2100666: (b)(4) items manufactured and released on 21-apr-2021.Expiration date: 2026-04-11.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.Additional components involved: batch review performed on 07 october 2024.Gmk-revision 02.07.0420scf fixed tibial insert sc size 4/20mm (k103170) lot 2111951: (b)(4) items manufactured and released on 10-jan-2022.Expiration date: 2026-12-21.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.Batch review performed on 07 october 2024.Gmk-revision 02.07.0684r revision fixed tibial tray cemented size 4 r (k123721) lot 2106366: (b)(4) items manufactured and released on 06-sep-2021.Expiration date: 2026-08-25.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.Batch review performed on 07 october 2024 gmk-revision 02.07.2404r femur revision ps size 4 r (k102437) lot 2215537: (b)(4) items manufactured and released on 18-oct-2022.Expiration date: 2027-10-02.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.
Event or Problem Description
At about 1 year 8 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: KNEE PATELLA RESURFACING
• 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: 20405450
• Report Number: 3005180920-2024-00828
• Device Sequence Number: 19727794
• Product Code: JWH
• UDI-Device Identifier: 07630030815775
• UDI-Public: 07630030815775
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 10/09/2024

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: 04/11/2026
• Device Model Number: 02.07.0036RP
• Device Lot Number: 2215537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2021
• 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 Sex: Male