MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL IDENTITY CR; TOTAL KNEE REPLACEMENT - CRUCIATE RETAINING

Model Number	TCR023060A01
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
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 tht could be resolved with simply a thicker insert.The device has not been received by the manufacturer for evaluation.
Event or Problem Description
The patient returned to the surgeon reporting flexion instability.The surgeon has requested a revision poly liner with additional constraint.

• Brand Name: ITOTAL IDENTITY CR
• Common Device Name: TOTAL KNEE REPLACEMENT - CRUCIATE RETAINING
• Manufacturer (Section D): CONFORMIS, INC.; 600 research drive; wilmington MA 01887
• Manufacturer (Section G): CONFORMIS, INC.; 600 research dr; wilmington MA 01887
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 23327790
• Report Number: 3004153240-2025-00018
• Device Sequence Number: 13405051
• Product Code: JWH
• UDI-Device Identifier: M572TCR023060A011
• UDI-Public: M572TCR023060A011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210809
• 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: 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: 04/30/2026
• Device Model Number: TCR023060A01
• Device Catalogue Number: TCR-023-060A
• Device Lot Number: 0557854
• 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: 04/25/2025
• 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 Age: 74 YR
• Patient Sex: Male