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

Catalog Number M57220600220

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 05/01/2014

Event Type  Injury  

Event Description

Femoral implant loosening was reported for patient with an iuni implant.Patient was revised to a tkr.

Manufacturer Narrative

Femoral implant loosening was reported for patient with an iuni implant.Patient was revised to a tkr.Review of the device history record indicates that the device was manufactured to specification.Device was returned and is being evaluated.Results will be documented in a supplemental report.

• 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: 3836002
• MDR Text Key: 4395238
• Report Number: 3004153240-2014-00059
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2013
• Device Catalogue Number: M57220600220
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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