MAUDE Adverse Event Report: RESTOR3D, INC IUNI KNEE REPLACEMENT; UNICOMPARTMENTAL KNEE REPLACEMENT

Model Number	RUK-101-1113
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The need for revision was identified in imaging, which shows subsidence of the tibial implant.The information provided is not sufficient to determine the exact root cause of the implant failure.A revision surgery is planned.The implants to be explanted wil be retrieved and analyzed after the surgery, evaluating the polymer component for signs of wear damage on the articulating surface and the locking surface where it interfaces with the metallic tibial implant.Furthermore, the bone and joint space will be evaluated for evidence of osteolysis.
Event or Problem Description
Patient is having a revision procedure to address tibial component loosening and wear on unicompartmental knee from 7 years ago.

• Brand Name: IUNI KNEE REPLACEMENT
• Common Device Name: UNICOMPARTMENTAL KNEE REPLACEMENT
• Manufacturer (Section D): RESTOR3D, INC; 4001 nc hwy 54; ste 3160; durham NC 27709
• Manufacturer (Section G): RESTOR3D, INC.; 600 research dr.; wilmington MA 01887
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 23687869
• Report Number: 3004153240-2025-00023
• Device Sequence Number: 18498946
• Product Code: JWH
• UDI-Device Identifier: M572RUK1011113021
• UDI-Public: M572RUK1011113021
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K133256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 10/31/2025

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: RUK-101-1113
• 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: 10/31/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2018
• 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: 56 YR
• Patient Sex: Female