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

Catalog Number M57220600220

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Patient reported pain and dissatisfaction.Revision to a total knee replacement occurred.

Manufacturer Narrative

Patient reported pain and dissatisfaction.Revision to a total knee replacement occurred.Review of the device history record indicates that the device was manufactured to specification.

• Brand Name: IUNI G2
• Type of Device: UNICONDYLAR KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS; 28 crosby drive; bedford MA 01730
• Manufacturer Contact: amita shah ; 28 crosby drive; bedford, MA 01730 ; 7813459164
• MDR Report Key: 3645548
• MDR Text Key: 4349660
• Report Number: 3004153240-2014-00013
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K092441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2012
• Device Catalogue Number: M57220600220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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: 57 YR