MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE TOTAL KNEE SYSTEM; GMK-HINGE FIXED TIBIAL TRAY SIZE 1 R

Model Number	02.09.4001R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 october 2024: lot 181159a: (b)(4) item manufactured and released on 06-sep-2023.Expiration date: 2028-aug-14.No anomalies found related to the problem.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.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2022.On (b)(6) 2024, the patient came in reporting pain after falling.The surgeon revised all components and the surgery was completed successfully.Presently, on (b)(6) 2024 the patient came in reporting pain due to a tibial fracture and the cause is unknown.The surgeon revised all components and the surgery was completed successfully.

• Brand Name: GMK HINGE TOTAL KNEE SYSTEM
• Common Device Name: GMK-HINGE FIXED TIBIAL TRAY SIZE 1 R
• 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: 20731985
• Report Number: 3005180920-2024-00941
• Device Sequence Number: 15529770
• Product Code: KRO
• UDI-Device Identifier: 07630030825521
• UDI-Public: 07630030825521
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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: 02.09.4001R
• Device Lot Number: 181159A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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: Female