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

Model Number	TCR000D00201
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the surgeon noticed a hole in both the inner and outer pouches for the tibial tray, potentially compromising sterility.There was a major delay of more than one hour to resterilise the implant.
Additional Manufacturer Narrative
It was reported that during the procedure, the surgeon noticed a hole in both the inner and outer pouches for the tibial tray, potentially compromising sterility.There was a major delay of more than one hour to resterilise the implant.Review of the device history record indicates that the device was manufactured and packaged to specification.All sterilisation requirements were met.

• Brand Name: ITOTAL IDENTITY IMPRINT 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: 12872434
• Report Number: 3004153240-2021-00206
• Device Sequence Number: 14580273
• Product Code: JWH
• UDI-Device Identifier: M572TCR000D002011
• UDI-Public: M572TCR000D002011
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K212411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/24/2021

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: TCR000D00201
• Device Catalogue Number: TCR-000-D002
• 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: 10/25/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• 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
• Patient Age: 55 YR
• Patient Sex: Unknown