MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIX CEMENTED S.4R

Model Number	02.07.1204R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to infection 7 months after primary surgery.The surgeon revised the tibial tray to a sensitin tray, the patella to a same size patella, the insert from a 10mm to an 11mm at the surgeon`s discretion and and femoral component to same size sensitin femoral component.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 19 mar 2026.- gmk-spherika 02.07.1204r tibial tray fix cemented s.4r lot 2436429 (k090988): (b)(4) items manufactured and released on 04-jun-2025.Expiration date: 2030-may-14.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-spherika 02.12.E003rp gmk-sphere resurfacing patella e-cross - s3lot 2504610 (k202022): (b)(4) items manufactured and released on 30-apr-2025.Expiration date: 2030-apr-10.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-spherika 02.12.E0410fr gmk-sphere tibial insert e-cross - flex 4r - 10mm lot 2504622 (k202022): (b)(4) items manufactured and released on 27-mar-2025.Expiration date: 2030-mar-11.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-spherika 02.12.Ka04r gmk spherika femoral component s4r cemented lot 2505577 (k211004): (b)(4) items manufactured and released on 07-may-2025.Expiration date: 2030-apr-22.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.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: TIBIAL TRAY FIX CEMENTED S.4R
• 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: 24738814
• Report Number: 3005180920-2026-00281
• Device Sequence Number: 21437913
• Product Code: JWH
• UDI-Device Identifier: 07630030819919
• UDI-Public: 07630030819919
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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 Model Number: 02.07.1204R
• Device Lot Number: 2436429
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2025
• 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: Female