MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; FEMUR SPHERE CEMENTED LEFT, SIZE 3+

Model Number	02.12.0023L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by clinical affairs department.One year after primary cemented tka, the patient complains of distal femoral pain, and the follow-up radiograph shows a cracked cement mantle.This may have occurred because of several types of incidents during cement preparation, such as higher than expected temperature of the room, a delay in cement application on the metal device, fluids getting trapped between cement and metal, or between successive layers of cement, or many other unknown factors.It should not be attributed to the devices implanted.Batch review performed on 11-04-2025: lot 2246109: 35 items manufactured and released on 22-02-2023.Expiration date: 2028-02-02.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 device revised: gmk-sphere 02.12.E0310fl tibial insert fixed sphere flex size 3/10 mm l e-cross (k202022) lot 2309307: (b)(4) items manufactured and released on 19-05-2023.Expiration date: 2028-05-07.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold with one similar reported event during the period of review.Based on the information available no definitive root cause can be established, the crack in the cement mantle is probably due to specific factors involved in the cement preparation.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.
Event or Problem Description
At about 11 months from primary the patient came in reporting distal femur pain.An x-ray showed the cement mantel was cracked on the femur.The surgeon decided to revise the femur and poly.Surgery was completed successfully, femur was downsized from 3+ to 3 and poly of the same thickness (10mm) was used.No mobilization of the femur was reported while the type of cement used is not known.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: FEMUR SPHERE CEMENTED LEFT, SIZE 3+
• 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: 21975646
• Report Number: 3005180920-2025-00356
• Device Sequence Number: 15272023
• Product Code: JWH
• UDI-Device Identifier: 07630030862373
• UDI-Public: 07630030862373
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• 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): 05/07/2025

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: 02.12.0023L
• Device Lot Number: 2246109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2023
• 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: 60 YR
• Patient Sex: Female