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

Catalog Number M57230600010

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Surgery is planned to resurface the patella for patient with a bicompartmental knee implant.Poly inserts may be exchanged during the procedure.

Manufacturer Narrative

Surgery is planned to resurface the patella for patient with a bicompartmental knee implant.Poly inserts may be exchanged during the procedure.Review of the device history record indicates that the device was manufactured to specification.

• Brand Name: IDUO
• Type of Device: BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS; 28 crosby dr.; bedford MA 01730
• Manufacturer Contact: amita shah ; 28 crosby drive; bedford, MA 01730 ; 7813459164
• MDR Report Key: 3625021
• MDR Text Key: 18568599
• Report Number: 3004153240-2014-00004
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053488
• 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: 01/10/2014

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: 11/01/2009
• Device Catalogue Number: M57230600010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2014
• Initial Date FDA Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• 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: 56 YR