MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R E-CROSS

Model Number	02.12.E0211FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 10 months from primary, the patient came in due to instability with an unknown cause.The surgeon revised the insert from an 11mm to a 14mm size.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 29-08-2025: lot 2308741: (b)(4) items manufactured and released on 30-05-2023 expiration date: 2028-05-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no 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.
Additional Manufacturer Narrative
Visual inspection performed by r&d department.Revision surgery of a gmk sphere e-cross tibial insert approximately two years after primary implantation, due to instability.During the revision procedure, the liner was replaced with a thicker one, increasing from 11 mm to 14 mm.Visual inspection of the explanted component, which was sent to medacta hq for investigation, did not reveal any anomalies potentially relevant to the event.The instability was likely a result of improper balancing during the primary surgery or may have developed over time due to progressive soft tissue laxity in the patient.Based on visual inspection, there is no indication that the event was related to a device malfunction or defect.Device evaluation added: d9.H3.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 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: 23093858
• Report Number: 3005180920-2025-00873
• Device Sequence Number: 9662957
• Product Code: JWH
• UDI-Device Identifier: 07630971261327
• UDI-Public: 07630971261327
• 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: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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 Expiration Date: 05/30/2023
• Device Model Number: 02.12.E0211FR
• Device Lot Number: 2308741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: White