MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM R E-CROSS

Model Number	02.12.E0314FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 1 month after the primary, the patient reported some instability in r knee.The surgeon made decision to upsize the poly to achieve greater stability (14 to 20 mm).
Additional Manufacturer Narrative
Batch review performed on 05 may 2025.Lot 2308749: (b)(4) items manufactured and released on 15-may-2023.Expiration date: 2028-04-24.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.Clinical evaluation performed by medical affairs department.One year after primary tka on a valgus patient, some instability is perceived and the surgeon decides to give more tension to the joint by replacing the current insert with a (significantly) thicker one, going from 14 to 20mm.Secondary instability is a known evolutionary problem, widely described in the specific literature, that may arise following tka for disease progression, such as secondary ligament stretching or depauperation.This reoperation is not due to a faulty or malfunctioning device.Conclusion: 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 3/14 MM R 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: 22060082
• Report Number: 3005180920-2025-00452
• Device Sequence Number: 7849881
• Product Code: JWH
• UDI-Device Identifier: 07630971261686
• UDI-Public: 07630971261686
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/21/2025

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.E0314FR
• Device Lot Number: 2308749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2023
• 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: 81 YR
• Patient Sex: Female