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

Catalog Number M57220600210

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 03/01/2014

Event Type  Injury  

Event Description

The patient fell resulting in a tibial fracture in the same knee and compartment as the iuni device.Revision surgery is planned.

Manufacturer Narrative

The patient fell resulting in a tibial fracture in the same knee and compartment as the iuni device.Revision surgery is planned.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, INC.; 323-c vintage park dr.; foster city CA 94404
• Manufacturer (Section G): CONFORMIS, INC.; 323-c vintage park dr.; foster city CA 94404
• Manufacturer Contact: amita shah ; 28 crosby drive; bedford, MA 01730 ; 7813459164
• MDR Report Key: 3760837
• MDR Text Key: 4486193
• Report Number: 3004153240-2014-00039
• 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: 03/25/2014

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: Health Professional
• Device Expiration Date: 06/01/2014
• Device Catalogue Number: M57220600210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2014
• Initial Date FDA Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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: 65 YR