MAUDE Adverse Event Report: CONFORMIS I DUO G2; BICOMPARTMENTAL KNEE REPLACEMENT

Catalog Number M57230600210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 05/01/2015

Event Type  Injury  

Event Description

Revision surgery is occurring for patient with an iduo implant due to continual pain.

Manufacturer Narrative

Revision surgery is occurring for patient with an iduo implant due to continual pain.Review of the device history record indicates that the device was manufactured to specification.

• Brand Name: I DUO G2
• Type of Device: BICOMPARTMENTAL KNEE REPLACEMENT
• Manufacturer (Section D): CONFORMIS; 28 crosby drive; bedford MA 01730
• Manufacturer Contact: karina snow ; 28 crosby drive; bedford, MA 01730 ; 7813459195
• MDR Report Key: 4906118
• MDR Text Key: 6031412
• Report Number: 3004153240-2015-00121
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• PMA/PMN Number: K093513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2013
• Device Catalogue Number: M57230600210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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