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

Model Number TPS111111102

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Scarring (2061)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient requires another procedure to remove excessive scar tissue.Revision surgery is planned to address the issue and exchange the poly insert.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the patient requires another procedure to remove excessive scar tissue.Revision surgery is planned to address the issue and exchange the poly insert.

• Brand Name: ITOTAL PS
• Type of Device: TOTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: emmanuel nyakako ; 600 technology park drive; billerica, MA 01821 ; 7813459164
• MDR Report Key: 11007887
• MDR Text Key: 221475655
• Report Number: 3004153240-2020-00234
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: M572TPS1111111021
• UDI-Public: +M572TPS1111111021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2020

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
• Device Operator: Health Professional
• Device Model Number: TPS111111102
• Device Catalogue Number: TPS-111-1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR