MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L E-CROSS

Model Number	02.12.E0310FL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 5 months from primary, during a postop appointment, the patient reported pain.The patient showed undefined complication on the tibia side.Currently it is not known whether a revision surgery will be performed.
Additional Manufacturer Narrative
Batch review performed on 29-apr-2025.Lot 2409786: (b)(4) items manufactured and released on 23-05-2024 expiration date: 2029-04-25.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold with no similar reported event during the period of review.Additional items involved in the event, batch review performed on 29-apr-2025: gmk-sphere 02.07.1203l tibial tray fixed cemented size 3 l (k090988) lot.2317415 lot 2317415: (b)(4) items manufactured and released on 04-10-2023.Expiration date: 2028-09-19.No anomalies found related to the problem.To date, all item of the same lot has been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0022l femoral component sphere cemented size 2+ l (k140826) lot.2339551 lot 2339551: (b)(4) items manufactured and released on 09-01-2024.Expiration date: 2028-12-17.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director: 5 months after primary cmeented tka, the patient complains about pain and the surgeon reports problems at tibial level, but no specification of the problem was supplied.No additional surgery performed or scheduled to date.With the information available, no clinical analysis of the situation can be performed properly.Root cause: due to the lack of information, it is not possible to establish a definitive root cause, while the device history record review does not indicate any potentially related manufacturing issue.
Additional Manufacturer Narrative
D2b has been updated from jwk to jwh.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 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: 22084131
• Report Number: 3005180920-2025-00453
• Device Sequence Number: 12489331
• Product Code: JWH
• UDI-Device Identifier: 07630971261518
• UDI-Public: 07630971261518
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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.E0310FL
• Device Lot Number: 2409786
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown