MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; RESURFACING PATELLA SIZE 4

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	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 years 5 months after the primary, the patient came in due to signs of infection with cutibacterium acnes and instability.The surgeon performed a washout, and revised all components from gmk-sphere to gmk-revision for increased stability.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 20 march 2026.Gmk-sphere 02.07.0036rp resurfacing patella size 4 (k11357) lot 2012794: (b)(4) items manufactured and released on 11-march-2021.Expiration date: 2026-02-24.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.Gmk-sphere 02.07.1205r gmk tibial tray cemented right s5 (k090988) lot 2203635: (b)(4) items manufactured and released on 08-june-2022.Expiration date: 2027-05-26.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.Gmk-sphere 02.12.0026r sphere femur cemented right s6 + (k140826) lot 1907946: (b)(4) items manufactured and released on 13-nov-2019.Expiration date: 2024-11-03.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.Gmk-sphere 02.12.0512fr gmk-sphere tibial insert - flex s5r - 12 mm (k121416) lot 2011405: (b)(4) items manufactured and released on 04-jan-2021.Expiration date: 2025-12-13.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.Root cause: 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: RESURFACING PATELLA SIZE 4
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24738815
• Report Number: 3005180920-2026-00291
• Device Sequence Number: 12460694
• Product Code: JWH
• UDI-Device Identifier: 07630030815775
• UDI-Public: 07630030815775
• Combination Product (Y/N): N
• PMA/510(K) Number: K113571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 02/24/2026
• Device Model Number: 02.07.0036RP
• Device Lot Number: 2012794
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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: Unknown