MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL G2; TOTAL KNEE REPLACEMENT SYSTEM

Catalog Number	TCR-111-SPEC
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient is having pain.Revision surgery is planned to exchange the poly inserts.Review of the device history record indicates that the device was manufactured to specification.All sterilization requirements were met.
Event or Problem Description
It was reported that the patient is having pain.Revision surgery is planned to exchange the poly inserts.

• Brand Name: ITOTAL G2
• Common Device Name: TOTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• MDR Report Key: 8515685
• Report Number: 3004153240-2019-00090
• Device Sequence Number: 1761801
• Product Code: JWH
• UDI-Device Identifier: M572TCR111SPEC021
• UDI-Public: +M572TCR111SPEC021
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2019

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 Catalogue Number: TCR-111-SPEC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/15/2019
• 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: 48 YR