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

Model Number	02.12.E0410FL
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 february 2025: lot 2346759: (b)(4) items manufactured and released on 12-april-2024.Expiration date: 2029-03-26.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.Batch review performed on 24 february 2025: gmk-sphere 02.12.T3i4l tibial tray fixed cemented size t3i4 l lot.2346759 (k121416) lot 2346976: (b)(4) items manufactured and released on 13-feb-2024.Expiration date: 2029-01-24.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.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.The surgeon revised also liner height, which is a common practice to restore joint stability.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
At about 7 months after the primary, the patient came in reporting pain due to a loose tibia and knee instability and the cause is unknown.The surgeon revised the tibia and insert (10 to 17mm).The surgery was completed successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE 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: 21595456
• Report Number: 3005180920-2025-00173
• Device Sequence Number: 18400703
• Product Code: JWH
• UDI-Device Identifier: 07630971261754
• UDI-Public: 07630971261754
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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: 2346976
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• 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 Sex: Female