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

Model Number	TPS121111102
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the femoral implant was not sitting flush to the surgeon's expectations.There was overhang on the lateral side and it appeared to need medial rotation.The surgeon attempted to reposition the femoral lug holes, but could not shift them any further.The surgery was completed successfully, but with a 15 to 20 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 femoral implant was not sitting flush to the surgeon's expectations.There was overhang on the lateral side and it appeared to need medial rotation.The surgeon attempted to reposition the femoral lug holes, but could not shift them any further.The surgery was completed successfully, but with a 15 to 20 minute delay in the procedure.

• Brand Name: ITOTAL PS
• Common Device Name: TOTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• MDR Report Key: 11240792
• Report Number: 3004153240-2021-00004
• Device Sequence Number: 4372152
• Product Code: JWH
• UDI-Device Identifier: M572TPS1211111021
• UDI-Public: +M572TPS1211111021
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K161668
• 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): 01/27/2021

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: TPS121111102
• Device Catalogue Number: TPS-121-1111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR