MAUDE Adverse Event Report: RESTOR3D, FORMERLY CONFORMIS ITOTAL IDENTITY PS; POSTERIOR STABILIZED TOTAL KNEE

Model Number	RPS0101400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This failure mode & occurrence rate is in alignment with what was evaluated as part of the risk assessment and the components were designed and manufactured correctly.It was noted on the surgical plan that a thicker than planned cut would be required, and appropriately thicker polys were ordered and available at the time of surgery.Based on the date of surgery and the wear testing done, it is unlikely that a well aligned implant would have worn to the extent of causing laxity so soon.No action is needed at this time unless this becomes a trend at a higher rate of failure than evaluated.
Event or Problem Description
This patient underwent a primary total knee on (b)(6) 2021.Patient has developed global instability and needs poly exchange.

• Brand Name: ITOTAL IDENTITY PS
• Common Device Name: POSTERIOR STABILIZED TOTAL KNEE
• Manufacturer (Section D): RESTOR3D, FORMERLY CONFORMIS; 600 research dr; wilmington MA 01887
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 23458814
• Report Number: 3004153240-2025-00020
• Device Sequence Number: 15472291
• Product Code: JWH
• UDI-Device Identifier: M572RPS0101400011
• UDI-Public: M572RPS0101400011
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K210252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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: RPS0101400
• 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: 10/15/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 64 YR
• Patient Sex: Female