MAUDE Adverse Event Report: CONFORMIS, INC ITOTAL G2; TOTAL KNEE REPLACEMENT - POSTERIOR STABILIZING

Model Number	TPS010060001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient returned to the surgeon with knee instability.A revision poly has been requested for additional constraint.
Additional Manufacturer Narrative
Review of production records reveals no abnormalities that could contribute to the reported adverse event.In a conversation with the operating physician, it was communicated that the patient has flexion instability and felt that a custom constrained insert would be the best clinical solution, as the patient does not have global instability that could be resolved with simply a thicker insert.The device has not been received by the manufacturer for evaluation.

• Brand Name: ITOTAL G2
• Common Device Name: TOTAL KNEE REPLACEMENT - POSTERIOR STABILIZING
• Manufacturer (Section D): CONFORMIS, INC; 600 research dr; wilmington MA 01887
• Manufacturer (Section G): RESTOR3D, INC; 4001 nc hwy 54; ste 3160; durham NC 27709
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 23327789
• Report Number: 3004153240-2025-00017
• Device Sequence Number: 16095376
• Product Code: JWH
• UDI-Device Identifier: M572TPS0100600011
• UDI-Public: M572TPS0100600011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

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 Expiration Date: 02/28/2023
• Device Model Number: TPS010060001
• Device Catalogue Number: TPS-010-0600
• Device Lot Number: 0497209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2022
• 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