MAUDE Adverse Event Report: NOVOSOURCE, LLC NOVOKNEE TOTAL KNEE SYSTEM; KNEE PROSTHESIS

Model Number	3311-4012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery a uc tibial insert trial size 2 (3311-4012) was inserted, the surgeon put the patient knee through a range of motion, and upon removal the uc tibial insert trial size 2 (3311-4012) fractured.It was reported that there was no patient injury or death, that the surgery was not prolonged and finally that the device was used as intended.

• Brand Name: NOVOKNEE TOTAL KNEE SYSTEM
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): NOVOSOURCE, LLC; 1000 hampton center; suite a; WV 26505
• Manufacturer (Section G): NOVOSOURCE, LLC; 1000 hampton center; suite a; morgantown WV 26505
• Manufacturer Contact: melinda larkin ; 1000 hampton center; suite a; morgantown, WV 26505 ; 3045542167
• MDR Report Key: 21424051
• Report Number: 3014273644-2025-00001
• Device Sequence Number: 15373676
• Product Code: JWH
• UDI-Device Identifier: 00811382036538
• UDI-Public: 00811382036538
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3311-4012
• Device Catalogue Number: 3311-4012
• Device Lot Number: PSV016876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female