MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; FEMORAL COMPONENT SPHERIKA CEMENTED S6+L

Model Number	02.12.KA16L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent primary surgery on (b)(6) 2023.On the (b)(6) 2023, the patient reported pain.On the (b)(6) 2024, neurontin treatment was performed, even if it had a limited efficacy.On (b)(6) 2024, the patient has been treated with corticosteroid injection (efficacy for 4 months).On (b)(6) 2025, the patient came in reporting pain and the patient has been again treated with corticosteroid injection.
Additional Manufacturer Narrative
Batch review performed on 22-apr-2025.(b)(4) items manufactured and released on 12-apr-2023.Expiration date: 26-mar-2028.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 few weeks after primary tka, the patient complains of pain, undescribed.Apparently, after one year of various treatments, the pain was not resolved.With no information at all, no comments or analysis can be made.Additional devices also involved: gmk-spherika 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot.2312266 (b)(4) items manufactured and released on 21-sep-2023.Expiration date: 02-sep-2028.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 02.12.0510fl tibial insert fixed sphere flex size5/10 mm l (k121416) lot.2316044 lot 2316044: (b)(4) items manufactured and released on 02-aug-2023.Expiration date: 12-jul-2028.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.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: FEMORAL COMPONENT SPHERIKA CEMENTED S6+L
• 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: 22027358
• Report Number: 3005180920-2025-00399
• Device Sequence Number: 18402760
• Product Code: JWH
• UDI-Device Identifier: 07630345716279
• UDI-Public: 07630345716279
• 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: 2023
• 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): 05/15/2025

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.KA16L
• Device Lot Number: 2301700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2023
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 50 KG