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

Model Number	TCR121111102
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is attributed to patient laxity, and the surgeon would like to use thicker poly inserts to improve the stability of the patient.Primary surgery occurred on (b)(6) 2021.Revision surgery planned date is unknown.Review of the device history record indicates that the device was manufactured to specification.All sterilisation requirements were met.
Event or Problem Description
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is attributed to patient laxity.Primary surgery occurred on (b)(6) 2019.Revision surgery is planned for (b)(6) 2021.

• Brand Name: ITOTAL CR
• Common Device Name: TOTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• MDR Report Key: 12257213
• Report Number: 3004153240-2021-00122
• Device Sequence Number: 14373043
• Product Code: JWH
• UDI-Device Identifier: M572TCR1211111021
• UDI-Public: M572TCR1211111021
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K180906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 07/31/2021

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: TCR121111102
• Device Catalogue Number: TCR-121-1111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR