MAUDE Adverse Event Report: CONFORMIS IDUO G2; BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM

Catalog Number M5723INT0600210

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

Patient Problem Pain (1994)

Event Date 12/01/2014

Event Type  Injury  

Event Description

Pt was hospitalized due to patella pain.Surgery occurred to resurface the patella.The patella was not resurfaced during the primary knee replacement surgery.

Manufacturer Narrative

Pt was hospitalized due to patella pain.Surgery occurred to resurface the patella.The patella was not resurfaced during the primary knee replacement surgery.Review of the device history record indicates that the device was manufactured to specification.

• Brand Name: IDUO G2
• Type of Device: BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS; 28 crosby dr; bedford MA 01730
• Manufacturer Contact: karina snow ; 28 crosby dr; bedford, MA 01730 ; 7813459195
• MDR Report Key: 4626863
• MDR Text Key: 16185168
• Report Number: 3004153240-2015-00043
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2015

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: 01/01/2014
• Device Catalogue Number: M5723INT0600210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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: 62 YR