MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM

Model Number	02.12.E0210FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 april 2025 lot 2345738: (b)(4) items manufactured and released on 18-dec-2023.Expiration date: 2028-12-02.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.Additional implaints also revised: gmk-spherika 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot.2347563 batch review performed on 17 april 2025 lot 2347563: (b)(4) items manufactured and released on 24-april-2024.Expiration date: 2029-04-08.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.Root cause: 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.
Event or Problem Description
At about 10 months after the primary, the patient came in reporting pain and stiffness and the inability to reach full extension in the knee and the cause is unknown.The surgeon explanted the tibia and polyethylene.He did a re-cut of the tibia and put in a size 1 tibia with a 14 mm poly the liner.The surgery was completed successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM
• 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: 21960296
• Report Number: 3005180920-2025-00386
• Device Sequence Number: 13074650
• Product Code: JWH
• UDI-Device Identifier: 07630971261280
• UDI-Public: 07630971261280
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 05/05/2025

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.E0210FR
• Device Lot Number: 2345738
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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 Sex: Female