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

Model Number	TCR000D00101
Health Effect - Clinical Codes	Limb Fracture (4518); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient's tibia was fractured during the insertion of the keel punch.The surgeon utilized screws to address the fracture and had the patient partial weight-bearing for six weeks.He noted that the patient "went on to heal nicely and obtain full range of motion".Review of the device history record indicates that the device was manufactured to specification.
Event or Problem Description
It was reported that the patient's tibia was fractured during insertion of the keel punch.The surgeon utilized screws to address the fracture and had the patient partial weight-bearing for six weeks.The surgeon noted that the patient "went on to heal nicely and obtain full range of motion".

• Brand Name: ITOTAL IDENTITY CR
• Common Device Name: TOTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• MDR Report Key: 10583761
• Report Number: 3004153240-2020-00161
• Device Sequence Number: 16839076
• Product Code: JWH
• UDI-Device Identifier: M572TCR000D001011
• UDI-Public: +M572TCR000D001011
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/24/2020

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: TCR000D00101
• Device Catalogue Number: TCR-000-D001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/24/2020
• 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: 79 YR