MAUDE Adverse Event Report: RESTOR3D, FORMERLY CONFORMIS ITOTAL IDENTITY CR TOTAL KNEE REPLACEMENT

Model Number	TCR0200700
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The potentials for instability, laxity, and pain resulting in a poly swap were evaluated within the device risk assessments, and the occurrence rate relative to this complaint are in alignment.Investigation did not reveal any manufacturing related problems.For poly swap revisions occurring less than years out from the initial surgery date, it is likely to be attributable to be surgically related to implant placement or alignment, soft tissue balance, or surgical technique etc.
Event or Problem Description
Patient indicated over the phone that they had ongoing pain.Patient had a revision of their (b)(6) 2024 implant on (b)(6) 2025 to have a poly swap with a different thickness.

• Brand Name: ITOTAL IDENTITY CR TOTAL KNEE REPLACEMENT
• Common Device Name: TOTAL KNEE REPLACEMENT
• Manufacturer (Section D): RESTOR3D, FORMERLY CONFORMIS; 600 research drive; wilmington MA 01887
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 23458736
• Report Number: 3004153240-2025-00019
• Device Sequence Number: 15424901
• Product Code: JWH
• UDI-Device Identifier: M572TCR0200700011
• UDI-Public: M572TCR0200700011
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K210809
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2025

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: TCR0200700
• 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: 10/08/2025
• Initial Report FDA Received Date: 11/03/2025
• 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: 70 YR
• Patient Sex: Female