MAUDE Adverse Event Report: RESTOR3D, INC. ITOTAL IDENTITY CR TOTAL KNEE REPLACEMENT

Model Number	TCR-301-1113
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of production record indicates the device wa manufactured to specification.It was reported that the patient fell, which likely caused the tibial loosening.It cannot be definitively determined if the component contributed to the failure mode.
Event or Problem Description
Patient is having revision procedure to address tibial component loosening from (b)(6) 2025 total knee replacement.

• Brand Name: ITOTAL IDENTITY CR TOTAL KNEE REPLACEMENT
• Common Device Name: TOTAL KNEE REPLACEMENT
• Manufacturer (Section D): RESTOR3D, INC.
• Manufacturer (Section G): RESTOR3D,INC.
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27705
• MDR Report Key: 23657871
• Report Number: 3004153240-2025-00022
• Device Sequence Number: 4824732
• Product Code: JWH
• UDI-Device Identifier: M572TCR3011113011
• UDI-Public: M572TCR3011113011
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K230846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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
• Device Model Number: TCR-301-1113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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 Age: 65 YR
• Patient Sex: Male