MAUDE Adverse Event Report: RESTOR3D, INC. ITOTAL IDENTITY CR; TOTAL KNEE REPLACEMENT

Model Number	POV0113509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Repeated dislocation, leading to revision surgery may be indicative of malpositioning of the articulating components (femoral relative to patella).Moreover, soft-tissue complications, outside the scope of the implant and instrument systems provided by restor3d are possible contributory factors.The implants were all manufactured according to specification.
Event or Problem Description
Patient called manufacturer to report "kneecap/patella dislocation" leading to revision surgery of the entire construct within 10 months of the index tka surgery.Repeated dislocation, leading to revision surgery.

• Brand Name: ITOTAL IDENTITY CR
• Common Device Name: TOTAL KNEE REPLACEMENT
• Manufacturer (Section D): RESTOR3D, INC.; 600 research drive; wilmington MA 01887
• Manufacturer (Section G): RESTOR3D, INC.; wilmington MA 01887
• Manufacturer Contact: brianna gabbard ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 25512145
• Report Number: 3014833750-2026-00016
• Device Sequence Number: 10589207
• Product Code: JWH
• UDI-Device Identifier: M572POV0113509011
• UDI-Public: M572POV0113509011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203447
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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 Expiration Date: 06/30/2026
• Device Model Number: POV0113509
• Device Lot Number: 1666385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2024
• 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