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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales rep reported that the patient warranted revision surgery due the patient having an infection.The surgeon will be doing a wash out and a poly swap.
Additional Manufacturer Narrative
The sales rep reported that the patient warranted revision surgery due the patient having an infection.The surgeon will be doing a wash out and a poly swap.The original surgery date was (b)(6) 2025.The new surgery date was (b)(6) 2025.This reported infection has occurred less than 1 year after the primary implant surgery.According to the sterilization records this sn was sterilized using the lts-v.This sn was sterilized on lts-v batch run# (b)(6) on (b)(6) 2024.There were no ncmr's associated with lts-v batch run # (b)(6).A review of this sn resulted in no non-conformances and would indicate the device was designed and manufactured to specifications.Endotoxin results were also reviewed and did not record any excursions during the period the product was processed through final manufacturing.Infection is a known complication of joint replacement surgery.Based on the available information, cause of infection cannot be conclusively determined to be related to the device.Cannot definitively determine if the device caused or contributed to the failure mode.Cannot definitively determine if the device caused or contributed to the failure mode.

• Brand Name: ITOTAL IDENTITY CR KRS
• Common Device Name: TOTAL KNEE REPLACEMENT
• Manufacturer (Section D): RESTOR3D, INC.; conformis; 600 research drive; wilmington MA 01887
• Manufacturer (Section G): RESTOR3D,INC; conformis; 600 research drive; wilmington MA 01887
• Manufacturer Contact: brianna prindle ; conformis; 600 research drive; wilmington, MA 01887
• MDR Report Key: 21264454
• Report Number: 3004153240-2025-00001
• Device Sequence Number: 12702713
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K231233
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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
• Operator of Device: Health Professional
• 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: 01/27/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 68 YR
• Patient Sex: Unknown