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

Catalog Number M5722INT0600210

Device Problem Positioning Problem (3009)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

Patient reported pain and impaired function.Surgeon consultation identified tibial implant overhang.Revision surgery is required.Review of the device history record indicates that the device was manufactured to specification.

Event Description

Patient reported pain and impaired function.Surgeon consultation identified tibial implant overhang.Revision surgery is required.

• Brand Name: IUNI G2
• Type of Device: UNICONDYLAR KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC; 28 crosby dr; bedford MA 01730
• Manufacturer Contact: karina snow ; 28 crosby dr; bedford, MA 01730 ; 7813459195
• MDR Report Key: 5522406
• MDR Text Key: 41029263
• Report Number: 3004153240-2016-00054
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: M5722INT0600210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2015
• 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: 74 YR