MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERIKA TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L E-CROSS

Model Number	02.12.E0410FL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 months after the primary, the patient came in reporting stiffness.Medical manipulation under anaesthesia has been performed in order to restore the joint mobility.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2025.Lot 2422805: (b)(4) items manufactured and released on 03-oct-2024.Expiration date: 2029-09-16.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 devices involved: batch reviews performed on (b)(6) 2025.Gmk-spherika 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot 2418300: (b)(4) items manufactured and released on 04-nov-2024.Expiration date: 2029-10-20.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.Ka15l femoral component spherika cemented size 5+l (k211004) lot 2337256: (b)(4) items manufactured and released on 05-feb-2024.Expiration date: 2029-01-20.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.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.Joint stiffness/reduced mobility is a possible literature described adverse event after total knee arthroplasty.There is no indication that any potential issue with the device may have caused or contributed to the event.
Additional Manufacturer Narrative
Clinical evaluation: few months after primary tka, stiffness is felt by the patient, and mobilization under anesthesia is carried out.According to the surgeon, this treatment solved the problem.The surgeon himself said that this type of situation occasionally presents itself after tka, and he thinks there is no relation whatsoever with the device implanted.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.Joint stiffness/reduced mobility is a possible literature described adverse event after total knee arthroplasty.There is no indication that any potential issue with the device may have caused or contributed to the event.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERIKA TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L E-CROSS
• 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: 21950432
• Report Number: 3005180920-2025-00374
• Device Sequence Number: 15662451
• Product Code: JWH
• UDI-Device Identifier: 07630971261754
• UDI-Public: 07630971261754
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/26/2025

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.E0410FL
• Device Lot Number: 2422805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2024
• 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: 58 YR
• Patient Sex: Male