MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; GMK-SPHERIKA FEMORAL COMPONENT S6R CEMENTED

Model Number	02.12.KA06R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02-october-2025.Gmk-spherika 02.12.Ka06r gmk spherika femoral component s6r cemented (k211004) lot 2308270: (b)(4) items manufactured and released on 21-jun-2023 expiration date: 2028-06-03.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 02.07.1205r tibial tray fix cemented s.5r (k090988) lot 2315165: (b)(4) items manufactured and released on 20-sept-2023 expiration date: 2028-09-04.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Gmk-spherika 02.12.0511fr gmk-sphere tibial insert - flex s5r - 11 mm (k140826) lot 2311181: (b)(4) items manufactured and released on 13-jul-2023 expiration date: 2028-06-26.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.Clinical evaluation performed by clinical affairs department: approximately six months after the primary implantation of a tka, the patient reported anterior knee pain.The presumed cause was identified as patellofemoral pain syndrome, associated with patellar bone remodeling, which led the surgeon to schedule a patellar resurfacing procedure.However, the surgery was not performed due to the patient's decision.From the available x-ray images, a patella alta and lateral patellar tilt are clearly visible in the preoperative images, indicating that this condition is intrinsic to the patient.The postoperative images show good positioning of the femoral and tibial components.Therefore, the symptomatology in this case may be related to the baseline patellofemoral morphology and possibly to the progression of the patellar pathology after the implantation of the tka.
Event or Problem Description
Patient underwent tka on (b)(6) 2024.On (b)(6) 2024 at followup the patient reported anterior knee pain.Test for infection were negative.Surgeon conclusion was that the pain was due to patella remodeling and that it would naturally improved over time.On (b)(6) 2024 patient still reported pain.Surgeon scheduled patella resurfacing for (b)(6) 2025 but patient cancelled the procedure on (b)(6) and could not be contacted anymore.It is unknown if the patient underwent additional or revision surgery or any other treatment.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERIKA FEMORAL COMPONENT S6R CEMENTED
• 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: 23321317
• Report Number: 3005180920-2025-01009
• Device Sequence Number: 13414827
• Product Code: JWH
• UDI-Device Identifier: 07630345716149
• UDI-Public: 07630345716149
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K211004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

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: 02.12.KA06R
• Device Lot Number: 2308270
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 110 KG