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

Model Number	TCR-101-1112-010101
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that revision surgery was needed after the patient developed an infection after the primary surgery.The original surgery date was (b)(6) 2022.The revision surgery was (b)(6) 2023.There have been no other reports of procedural or post-operative complications for this patient.The ncmr records were reviewed and there were no reports for this sn.Infection is a known complication of joint replacement surgery.Cause of infection cannot be conclusively determined with available information.
Event or Problem Description
It was reported that revision surgery was needed after the patient developed an infection after the primary surgery.The original surgery date was (b)(6) 2022.The revision surgery was (b)(6) 2023.
Additional Manufacturer Narrative
3/20/2023 this follow-up report is being filed as it was discovered on review of the filed mdr report that the incorrect incident date was provided in the original mdr report.The actual incident date was (b)(6) 2023 ((b)(6) 2023).
Event or Problem Description
It was reported that revision surgery was needed after the patient developed an infection after the primary surgery.The original surgery date was (b)(6) 2022.The revision surgery was (b)(6) 2023.

• Brand Name: ITOTAL IDENTITY CR
• Common Device Name: TOTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS INC; 600 technology park drive; fourth floor; billerica MA 01821
• Manufacturer (Section G): CONFORMIS INC; 600 research dr; wilmington MA 01887
• Manufacturer Contact: elizabeth haines ; 600 research dr; wilmington, MA 01887
• MDR Report Key: 16398112
• Report Number: 3004153240-2023-00011
• Device Sequence Number: 6375781
• Product Code: JWH
• UDI-Device Identifier: M572TCR1011112011
• UDI-Public: M572TCR1011112011
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• 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-101-1112-010101
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male