MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL INSERT PS FIX S.2 / 12 MM

Model Number	02.07.0212PSF
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	08/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision due to an infection and the pathogen is unknown.At about 1 year and 6 months post primary the surgeon removed all components, performed a washout, and reimplanted permanent hardware.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch reviews performed on 01 september 2025: gmk-revision 02.07.0212psf tibial insert ps fix s.2 / 12 mm (k090988) lot: 2242132: (b)(4) items manufactured and released on 13-jan-2024.Expiration date: 2027-12-26.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 involved: gmk-revision 02.07.0682l revision tibial tray size 2 left - finishing (k123721) lot: 2316790: (b)(4) items manufactured and released on 22-dec-2023.Expiration date: 2028-12-09.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-revision 02.07.2403l femur revision ps cemented s.3l (k102437) lot: 2118569: (b)(4) items manufactured and released on 04-dec-2022.Expiration date: 2027-04-20.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.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: TIBIAL INSERT PS FIX S.2 / 12 MM
• 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: 23063083
• Report Number: 3005180920-2025-00879
• Device Sequence Number: 15870838
• Product Code: JWH
• UDI-Device Identifier: 07630030816581
• UDI-Public: 07630030816581
• 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: 2024
• Device Explanted Year: 2025
• 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): 09/16/2025

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: 02.07.0212PSF
• Device Lot Number: 2242132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2024
• 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 Sex: Unknown