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

Model Number	TPS121111102
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the surgeon had issues with the positioning of the f4 ijig.The rotation of the jig appeared to be off which resulted in some overhang of the femoral implant.The surgeon repeated placement of the f2 and f3 to drill the distal holes for the f4 resulting in a better positioning for the f4.The surgery was completed successfully.Review of the device history record indicates that the device was manufactured to specification.
Event or Problem Description
It was reported that the surgeon had issues with the positioning of the f4 ijig.The rotation of the jig appeared to be off which resulted in some overhang of the femoral implant.The surgeon repeated placement of the f2 and f3 to drill the distal holes for the f4 resulting in a better positioning for the f4.The surgery was completed successfully.

• 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: 11240763
• Report Number: 3004153240-2021-00005
• Device Sequence Number: 4372153
• 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: 12/31/2020
• 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: 57 YR