MAUDE Adverse Event Report: restor3d, inc. iTotal® Identity¿ Cruciate Retaining 3DP Porous Knee Replacement System; Cruciate Retaining Total Knee Replacement

Model Number	TCR-000-D005-020111
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The design of the t1 instrument used to guide the tibial resection is based on segmented ct data from the patient.An error in the segmentation for this particular instrument has been identified, which in combination with the known soft tissue attachment sites of the tibial tuberosity may have contributed to difficulty in achieving adequate seating of the instrument and led to the reported angulated cut.Review of production records reveals no abnormalities in the manufacture of the subject component.Review of the segmentation process is ongoing to determine future preventative actions.
Event or Problem Description
The surgeon reported that the tibial resection guide placed resection in varus and had to manually correct the resection, but the final outcome was still in varus.Postoperatively, the patient presented with patellar "clunking" and the surgeon feels this is caused by the varus tibial resection and mal-rotation.The surgeon plans to revise the tibial side of the construct to resolve the issue.

• Brand Name: iTotal® Identity¿ Cruciate Retaining 3DP Porous Knee Replacement System
• Common Device Name: Cruciate Retaining Total Knee Replacement
• Manufacturer (Section D): restor3d, inc.; 600 research drive; wilmington MA 01887
• Manufacturer (Section G): restor3d, inc.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: brianna gabbard ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 50090425
• Report Number: 3014833750-2026-00032
• Device Sequence Number: 15931018
• Product Code: MBH
• UDI-Device Identifier: 00840097515168
• UDI-Public: 00840097515168
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K243768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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?: Yes
• Device Model Number: TCR-000-D005-020111
• Device Lot Number: 0621725
• 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: 06/24/2026
• Initial Report FDA Received Date: 07/30/2026
• 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