MAUDE Adverse Event Report: CONFORMIS INC ITOTAL IDENTITY CR; TOTAL KNEE REPLACEMENT SYSTEM

Model Number	TCR-101-1112-020101
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cause of the infection is unknown.The ncmr records were reviewed and the device was shipped under transportation quarantine, however the quarantine was lifted prior to the use of the device.The listed risk analysis was reviewed.Infection is a known risk of total knee replacement surgery.
Event or Problem Description
Replacement poly inserts were ordered for revision surgery due to infection.The original surgery was (b)(6)2022 and the revision surgery was(b)(6)2023.The cause of the infection is unknown.

• Brand Name: ITOTAL IDENTITY CR
• Common Device Name: TOTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS INC; 600 technology park dr; billerica MA 01821
• Manufacturer (Section G): CONFORMIS INC; 600 research bvd; wilmington MA 01887
• Manufacturer Contact: elizabeth haines ; 600 technology park drive; billerica, MA 01821
• MDR Report Key: 16399528
• Report Number: 3004153240-2023-00012
• Device Sequence Number: 14838776
• Product Code: JWH
• UDI-Device Identifier: M572TCR1011112011
• UDI-Public: M572TCR1011112011
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K210809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

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
• Device Model Number: TCR-101-1112-020101
• Device Catalogue Number: TCR1011112
• 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: 01/25/2022
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2022
• 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; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Unknown