MAUDE Adverse Event Report: RESTOR3D, INC. (FORMERLY CONFORMIS) ITOTAL CR G2; TOTAL KNEE REPLACEMENT

Model Number	RCR-301-1113
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Limb Pain (4836); Aseptic loosening (4883)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Late onset (>1 year post-operative) swelling and sibsidence is likely due to improper kinematics.The root cause of the improper kinematics may result from inadequate implant design, improper jig design, misuse of the jigs and/or improper implant placement.No anomalies were found in the case design or manufacturing.
Event or Problem Description
The patient called to leave a complaint that the knee never felt right 1-2 years post-operatively.In 2022, the left knee became swollen and bone scan showed patella component loosening.Other components may be loosening too and will require a revision surgery.

• Brand Name: ITOTAL CR G2
• Common Device Name: TOTAL KNEE REPLACEMENT
• Manufacturer (Section D): RESTOR3D, INC. (FORMERLY CONFORMIS); 600 research drive; wilmington MA 01887
• Manufacturer (Section G): RESTOR3D, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27705
• MDR Report Key: 25177149
• Report Number: 3014833750-2026-00013
• Device Sequence Number: 21377981
• Product Code: JWH
• UDI-Device Identifier: M572RCR3011113011
• UDI-Public: M572RCR3011113011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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 Model Number: RCR-301-1113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2017
• 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: Female