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

Catalog Number M5722INT0600210

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Code Available (3191)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

An iuni g2 left knee implant was requested for surgery.An itotal implant was provided.The error was identified in the or while the patient was under anesthesia.The surgery had not started.Dhr review confirms a left knee iuni g2 implant was ordered.Implant request form did not identify knee compartment (medial or lateral).The order was incorrectly entered into the system.Order review did not identify the error.Product was manufactured per the order entered into the system.

Event Description

An iuni g2 left knee implant was requested for surgery.An itotal implant was provided.The error was identified in the or while the patient was under anesthesia.No surgery was performed.

• Brand Name: IUNI G2
• Type of Device: UNICONDYLAR 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: 5353220
• MDR Text Key: 35698074
• Report Number: 3004153240-2016-00004
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: M5722INT0600210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2015
• 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 Age: 52 YR