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

Model Number TPS111111101

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the procedure for the debridement of soft tissue was performed for a patient with an itotal knee replacement due to a patella crepitation.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the procedure for the debridement of soft tissue was performed for a patient with an itotal knee replacement due to a patella crepitation.

• 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: thomas haueter ; 600 technology park drive; billerica, MA 01821 ; 7813459161
• MDR Report Key: 7600354
• MDR Text Key: 111008332
• Report Number: 3004153240-2018-00141
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: M572TPS1111111011
• UDI-Public: +M572TPS1111111011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142404
• 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: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2016
• Device Model Number: TPS111111101
• Device Catalogue Number: TPS-111-1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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: 55 YR