MAUDE Adverse Event Report: CONFORMIS, INC. IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM

Catalog Number M57220600240

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Synovitis (2094); Limited Mobility Of The Implanted Joint (2671)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

Surgeon reported that patient had unusual synovitis post-op that required a steroid injection and continued narcotics.The patient has had suboptimal range of motion at this point.Review of the device history record indicates that the device was manufactured to specification.

Event Description

Surgeon reported that patient had unusual synovitis post-op that required a steroid injection and continued narcotics.The patient has had suboptimal range of motion at this point.

• Brand Name: IUNI G2
• Type of Device: UNICONDYLAR KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 28 crosby drive; bedford MA 01730
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: karina snow ; 28 crosby drive; bedford, MA 01730 ; 7813459195
• MDR Report Key: 5165040
• MDR Text Key: 28832035
• Report Number: 3004153240-2015-00198
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K111916
• 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: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: M57220600240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2015
• 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: 52 YR