MAUDE Adverse Event Report: RESTOR3D, INC (FORMERLY CONFORMIS) ITOTAL IDENTITY PS KNEE; TOTAL KNE REPLACEMENT

Model Number	TPS-101-1112; TPS-301-1113; TPS-020-0600; POV-021-3809
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Septic loosening (4884)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Infection almost 1 year from the date of initial surgery is not believed to be attributed to the device.
Event or Problem Description
The patient requires revision surgery due to patient infection after total knee replacement.The components were manufactured, packaged, and sterilized correctly and it is not believed that the implant caused the infection and subsequent revision.

• Brand Name: ITOTAL IDENTITY PS KNEE
• Common Device Name: TOTAL KNE REPLACEMENT
• Manufacturer (Section D): RESTOR3D, INC (FORMERLY CONFORMIS); 600 research drive; wilmington MA 01887
• Manufacturer (Section G): RESTOR3D, INC. (FMR. CONFORMIS); 600 research drive; wilmington MA 01887
• Manufacturer Contact: brianna gabbard ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 25840725
• Report Number: 3014833750-2026-00025
• Device Sequence Number: 20252806
• Product Code: JWH
• UDI-Device Identifier: M572TPS1011112111
• UDI-Public: M572TPS1011112111
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2026

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 Expiration Date: 08/31/2026
• Device Model Number: TPS-101-1112; TPS-301-1113; TPS-020-0600; POV-021-3809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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: Unknown