MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; GMK-SPHERIKA FEMORAL COMPONENT SPHERIKA CEMENTED S5L

Model Number	02.12.KA05L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 7 april 2025: lot 2307482: (b)(4) items manufactured and released on 06/06/2023.Expiration date: 23/05/2028.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.Additional devices involved batch reviews performed on 7 april 2025: gmk-spherika 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot 2242030: (b)(4) items manufactured and released on 02/02/2023.Expiration date: 18/01/2028.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 02.12.0410fl tibial insert fixed sphere flex size 4/10 mm l (k121416) lot 2244438: (b)(4) items manufactured and released on 30/01/2023.Expiration date: 13/01/2028.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.
Event or Problem Description
About 1 year and 9 months after the primary surgery, the patient was revised due to signs of inflammation (subquadricipital effusion), of unknown origin.Patient's natural patella was also resurfaced.Hypotheses remain a possible chondrolysis of the patella or an allergic phenomenon.
Additional Manufacturer Narrative
Follow-up: - devices not available for investigation.- all components revised.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERIKA FEMORAL COMPONENT SPHERIKA CEMENTED S5L
• 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: 21855347
• Report Number: 3005180920-2025-00325
• Device Sequence Number: 11942000
• Product Code: JWH
• UDI-Device Identifier: 07630345716118
• UDI-Public: 07630345716118
• 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
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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.KA05L
• Device Lot Number: 2307482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male