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

Model Number	TCR111111102
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that replacement poly inserts (8mm, 10mm, 12mm, 14mm, c, e, g, j) and tibial tray implant have been requested for revision surgery.Reason for revision is tibial implant loosening of unknown cause.Primary surgery occurred on (b)(6) 2017.Revision surgery is planned for (b)(6) 2022.The device dhr was reviewed and the device was manufactured to specification.All sterilisation requirements were met.
Event or Problem Description
It was reported that replacement poly inserts (8mm, 10mm, 12mm, 14mm, c, e, g, j) and tibial tray implant have been requested for revision surgery.Reason for revision is tibial implant loosening of unknown cause.Primary surgery occurred on (b)(6) 2017.Revision surgery is planned for (b)(6) 2022.

• Brand Name: ITOTAL CR
• Common Device Name: TOTAL KNEE REPAIR SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: kara johnson ; 600 technology park drive; billerica, MA 01821
• MDR Report Key: 14181058
• Report Number: 3004153240-2022-00061
• Device Sequence Number: 17396330
• Product Code: JWH
• UDI-Device Identifier: M572TCR1111111021
• UDI-Public: M572TCR1111111021
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 04/21/2022

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: TCR111111102
• Device Catalogue Number: TCR-111-1111
• 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: 03/22/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Unknown