MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L E-CROSS

Model Number	02.12.E0311FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After seven months post-primary surgery, the patient presented with instability of unknown cause.The surgeon upsized the polyethylene insert from 11 mm to 20 mm to improve stability.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 10 october 2025.Lot 2308746: (b)(4) items manufactured and released on 22 may 2023.Expiration date: 01 may 2028.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with a similar reported event during the period of review.The surgeon revised liner height, which is a common practice to restore the joint stability.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: TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 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: 23356472
• Report Number: 3005180920-2025-01037
• Device Sequence Number: 15671282
• Product Code: JWH
• UDI-Device Identifier: 07630971261556
• UDI-Public: 07630971261556
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: 2308746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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.E0311FL
• Device Lot Number: 2308746
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2023
• 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: 59 YR
• Patient Sex: Female