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

Model Number	02.12.KA16R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 months after the primary, the patient came in reporting stiffness.Open arthrolysis has been performed in order to restore the joint mobility.
Additional Manufacturer Narrative
Batch review performed on 25 august 2025: gmk-spherika 02.12.Ka16r femoral component spherika cemented s6+r lot.2401780 (k211004) lot 2401780: (b)(4) items manufactured and released on 24-april-2024.Expiration date: 2029-04-10.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.Additional implants revised, batch review performed on 25 august 2025: gmk-spherika 02.07.1206r tibial tray fixed cemented size 6 r (k090988) lot 2412638: (b)(4) items manufactured and released on 02-sep-2024.Expiration date: 2029-07-28.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-spherika 02.12.0610fr tibial insert fixed sphere flex size 6/10 mm r (k121416) lot 2108933: (b)(4) items manufactured and released on 16-sep-2021.Expiration date: 2026-09-02.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.Conclusion: the development of stiffness of the joint is a rather commonly described possible complication following tka, surgeon decided to treat the patient with knee manipulation.There is no indication that any potential issue with the device may have caused or contributed to the event.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: FEMORAL COMPONENT SPHERIKA CEMENTED S6+R
• 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: 23001780
• Report Number: 3005180920-2025-00874
• Device Sequence Number: 8806769
• Product Code: JWH
• UDI-Device Identifier: 07630345716286
• UDI-Public: 07630345716286
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2025

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.KA16R
• Device Lot Number: 2401780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2024
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 90 KG