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

Catalog Number M5723INT0600220

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the tibial tray was originally placed with a small medial overhang.A revision surgery is planned to exchange and re-position the tibial tray.Review of the device history record indicates that the device was manufactured to specification.

Event Description

It was reported that the tibial tray was originally placed with a small medial overhang.A revision surgery is planned to exchange and re-position the tibial tray.

• Brand Name: IDUO G2
• Type of Device: BICOMPARTMENTAL 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: 6308660
• MDR Text Key: 66720740
• Report Number: 3004153240-2017-00028
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: M5723INT0600220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2015
• 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