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

Catalog Number MS7250600010

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/09/2015

Event Type  Injury  

Event Description

The pt is in a few degrees of varus post-operatively.Revision surgery is planned to exchange the poly inserts.

Manufacturer Narrative

Review of the device history record indicates that the device was manufactured to spec.

Manufacturer Narrative

Due to chronic pain related to arthrofibrosis and lateral laxity, revision surgery occurred to exchange the lateral poly insert and remove arthrofibrosis.Review of the device history record indicates that the device was manufactured to specification.

Event Description

Due to chronic pain related to arthrofibrosis and lateral laxity, revision surgery occurred to exchange the lateral poly insert and remove arthrofibrosis.

• Brand Name: ITOTAL G2
• Type of Device: TOTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS; 28 crosby dr; bedford MA 01730
• Manufacturer Contact: karina snow ; 28 crosby dr; bedford, MA 01730 ; 7813459195
• MDR Report Key: 4763232
• MDR Text Key: 20369406
• Report Number: 3004153240-2015-00080
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2015
• Device Catalogue Number: MS7250600010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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: 71 YR