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

Catalog Number M57220600210

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 08/19/2015

Event Type  Injury  

Manufacturer Narrative

Patient with a unicondylar knee implant was revised to an off the shelf total knee implant system.It was reported that the poly insert never engaged with the tibial tray posteriorly.Review of the device history record indicates that the device was manufactured to specification.

Event Description

Patient with a unicondylar knee implant was revised to an off the shelf total knee implant system.It was reported that the poly insert never engaged with the tibial tray posteriorly.

• Brand Name: IUNI G2
• Type of Device: UNICONDYLAR KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 28 crosby drive; bedford MA 01730
• Manufacturer Contact: karina snow ; 28 crosby drive; bedford, MA 01730 ; 7813459195
• MDR Report Key: 5073727
• MDR Text Key: 25621222
• Report Number: 3004153240-2015-00172
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/14/2015

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: Physician
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: M57220600210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2015
• Initial Date FDA Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2014
• 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: 47 YR