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

Catalog Number M57230600220

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

Patient developed an infection.Device removal planned as part of a multi-stage revision.Review of the device history record indicates the device was manufactured to specification.All sterilization requirements were met.

Event Description

Patient developed an infection.Device removal is planned as part of a multi-stage revision.

• Brand Name: IDUO G2
• Type of Device: BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 28 crosby drive; bedford MA 01730
• Manufacturer Contact: karina snow ; 28 crosby drive; bedford, MA 01730 ; 7813459195
• MDR Report Key: 5243874
• MDR Text Key: 31975185
• Report Number: 3004153240-2015-00217
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2015

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: Physician
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: M57230600220
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2015
• 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: 38 YR