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

Catalog Number M57220600220

Device Problems Device Slipped (1584); Scratched Material (3020)

Patient Problem No Code Available (3191)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that the femoral implant was loose and re-cemented in a previous procedure.During the procedure, the poly insert was examined and determined to be scratched.A revision surgery is planned to exchange the poly insert.Review of the device history record indicates the device was manufactured to specification.

Event Description

It was reported that the femoral implant was loose and re-cemented in a previous procedure.During the procedure, the poly insert was examined and determined to be scratched.A revision surgery is planned to exchange the poly insert.

Manufacturer Narrative

It was originally reported that the femoral implant was loose and re-cemented in a previous procedure.During the procedure, the poly insert was examined and determined to be scratched.A revision surgery was scheduled to exchange the poly insert.During the revision surgery, femoral loosening was identified.The patient was converted to a total knee replacement system.

Event Description

It was originally reported that the femoral implant was loose and re-cemented in a previous procedure.During the procedure, the poly insert was examined and determined to be scratched.A revision surgery was scheduled to exchange the poly insert.During the revision surgery, femoral loosening was identified.The patient was converted to a total knee replacement system.

• 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: 5781667
• MDR Text Key: 49129265
• Report Number: 3004153240-2016-00146
• 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,Followup
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/30/2013
• Device Catalogue Number: M57220600220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2013
• 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: 50 YR