MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL G2; TOTAL KNEE REPLACEMENT SYSTEM

Catalog Number M57250600010

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient has some grinding in the joint.It was also reported that there is concern the poly could be broken.A revision surgery is planned to exchange the poly inserts.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the patient has some grinding in the joint.It was also reported that there is concern the poly could be broken.A revision surgery is planned to exchange the poly inserts.

• Brand Name: ITOTAL G2
• Type of Device: TOTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• Manufacturer Contact: thomas haueter ; 600 technology park drive; billerica, MA 01821 ; 7813459161
• MDR Report Key: 7828373
• MDR Text Key: 118615449
• Report Number: 3004153240-2018-00199
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140423
• 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: 08/29/2018

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 Expiration Date: 11/30/2014
• Device Catalogue Number: M57250600010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2014
• 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: 73 YR