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

Model Number	TCR000D00101
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient's knee was very tight in deep flexion intra-operatively.The surgeon noted that there appeared to not be enough slope cut using the metal cutting guide.He decided to recut the tibia to form more slope with the saw blade.It was also reported that the trial femoral component snapped in half during the trialing phase.The surgeon utilized the femoral implant with the trials to successfully complete the surgery.These issues resulted in a 29 minute delay in the procedure.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 knee was very tight in deep flexion intra-operatively.The surgeon noted that there appeared to not be enough slope cut using the metal cutting guide.He decided to recut the tibia to form more slope with the saw blade.It was also reported that the trial femoral component snapped in half during the trialing phase.The surgeon utilized the femoral implant with the trials to successfully complete the surgery.These issues resulted in a 29 minute delay in the procedure.

• 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: 10638890
• Report Number: 3004153240-2020-00177
• Device Sequence Number: 19584031
• Product Code: JWH
• UDI-Device Identifier: M572TCR000D001011
• UDI-Public: +M572TCR000D001011
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/26/2020

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?: Yes
• 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: 09/10/2020
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR