MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; KNEE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 RIGHT

Model Number	02.12.0004R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had knee pain and stiffness and the cause is unknown.At about 1 year and 3 months post primary the surgeon revised the patient to a hinge knee and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 05 february 2025: lot 2309760: (b)(4) items manufactured and released on 02-aug-2023.Expiration date: 2028-07-12.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.Additional implants revised: batch review performed on 05 february 2025 on gmk-sphere 02.12.E0412fr tibial insert fixed sphere flex size 4/12 mm r e-cross (k202022) lot.2310262.Lot 2310262: (b)(4) items manufactured and released on 05-06-2023.Expiration date: 2028-05-28.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.Batch review performed on 05 february 2025 on gmk-sphere 02.12.T3i4r tibial tray fixed cemented size t3i4 r (k121416) lot.2309319.Lot 2309319: (b)(4) items manufactured and released on 29-08-2023.Expiration date: 2028-08-09.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.There is no indication that any potential issue with the device may have caused or contributed to the event, and the investigation does not indicate any potential manufacturing related issue.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: KNEE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 RIGHT
• 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: 21411260
• Report Number: 3005180920-2025-00110
• Device Sequence Number: 8317332
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/19/2025

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: 02.12.0004R
• Device Lot Number: 2309760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• 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: 55 YR
• Patient Sex: Male