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

Model Number	TCR301111301
Health Effect - Clinical Code	Erosion (1750)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the patient had tibial erosion within the lateral compartment of their tibia discovered during the planning for their itotal knee replacement.Conformis engineering and the surgeon reviewed the case and deemed that the patient would not be a candidate for an itotal implant.The sales agent contacted customer service via phone to cancel the case, but did not submit the cancellation in written/ email form as was requested by customer service.Without the cancellation initiated, the case continued through production and was sent to the hospital for the procedure.The surgeon proceeded with the case and found that the tibial base plate could not provide adequate coverage within the lateral portion of the tibia and was unstable in flexion.A stryker tibial base plate was utilized along with the conformis femoral component and conformis cutting guides.The surgery was completed successfully.Review of the device history record indicates that the device was manufactured to specification.Retraining of the sales team is underway to ensure that cancellations are provided to customer service in written/ email form.
Event or Problem Description
It was reported that the patient had tibial erosion within the lateral compartment of their tibia discovered during the planning for their itotal knee replacement.Conformis engineering and the surgeon reviewed the case and deemed that the patient would not be a candidate for an itotal implant.The sales agent contacted customer service via phone to cancel the case, but did not submit the cancellation in written form as was requested by customer service.Without the cancellation initiated, the case continued through production and was sent to the hospital for the procedure.The surgeon proceeded with the case and found that the tibial base plate could not provide adequate coverage within the lateral portion of the tibia and was unstable in flexion.A stryker tibial base plate was utilized along with the conformis femoral component and conformis cutting guides.The surgery was completed successfully.

• 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: 11668123
• Report Number: 3004153240-2021-00057
• Device Sequence Number: 4167594
• Product Code: JWH
• UDI-Device Identifier: M572TCR3011113011
• UDI-Public: +M572TCR3011113011
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K190562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TCR301111301
• Device Catalogue Number: TCR-301-1113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1