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

Model Number	TCR301T03S01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient returned for revision knee surgery with a well-fixed femoral, while tibial implant experienced aseptic loosening.
Additional Manufacturer Narrative
The original reporter was consulted for additional information and it was determined to be a standard tibial aseptic loosening, which is a known failure in total knee replacement.There is insufficient clinical information to establish a root cause of this revision; aseptic loosening occurrence is compared to risk assessment and monitored.

• Brand Name: IDENTITY IMPRINT CR
• Common Device Name: TOTAL KNEE REPLACEMENT
• Manufacturer (Section D): RESTOR3D, INC; 4001 nc hwy 54; ste 3160; durham NC 27709
• Manufacturer (Section G): RESTOR3D, INC.
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 25165077
• Report Number: 3014833750-2026-00012
• Device Sequence Number: 10643849
• Product Code: MBH
• UDI-Device Identifier: M572TCR301T03S011
• UDI-Public: M572TCR301T03S011
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K230846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: TCR301T03S01
• Device Lot Number: 1404728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/13/2026
• 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: 59 YR
• Patient Sex: Unknown