MAUDE Adverse Event Report: CONFORMIS, INC. IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM

Model Number M57220600210

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Complaint, Ill-Defined (2331)

Event Date 07/29/2015

Event Type  Injury  

Manufacturer Narrative

Per user facility report # (b)(4): patient with bilateral unicompartmental knee arthroplasty.Estimated blood loss during procedure 400 cc.Patient with post-operative anemia, hypotension, and positive hemoccult.H&h not responsive to blood transfusion.Cause is unknown.Review of the device history record indicates that the device was manufactured to specification.This report is for a bilateral procedure.Serial numbers and model numbers implanted: sn (b)(4), m57220600210.Sn (b)(4), m57220600220.

Event Description

Per user facility report # (b)(4): patient with bilateral unicompartmental knee arthroplasty.Estimated blood loss during procedure 400 cc.Patient with post-operative anemia, hypotension, and positive hemoccult.H&h not responsive to blood transfusion.

• Brand Name: IUNI G2
• Type of Device: UNICONDYLAR KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 28 crosby drive; bedford MA 01730
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: karina snow ; 28 crosby drive; bedford, MA 01730 ; 7813459195
• MDR Report Key: 5207130
• MDR Text Key: 30582525
• Report Number: 3004153240-2015-00211
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2016
• Device Model Number: M57220600210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 59 YR