MAUDE Adverse Event Report: CONFORMIS, INC. IDUO G2; BICOMPARTMENTAL KNEE REPLACEMENT SYS

Catalog Number M5723INT0600240

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Revision surgery is planned to exchange the poly insert for pt with a bicompartmental knee implant.

Manufacturer Narrative

Revision surgery is planned to exchange the poly insert for pt with a bicompartmental knee implant.Review of the device history record indicates that the device was manufactured to specifications.

• Brand Name: IDUO G2
• Type of Device: BICOMPARTMENTAL KNEE REPLACEMENT SYS
• Manufacturer (Section D): CONFORMIS, INC.; 28 crosby dr; bedford MA 01730
• Manufacturer Contact: amita shah ; 28 crosby dr; bedford, MA 01730 ; 7813459164
• MDR Report Key: 3649241
• MDR Text Key: 4184053
• Report Number: 3004153240-2014-00023
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2013
• Device Catalogue Number: M5723INT0600240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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: 58 YR