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

Catalog Number M5722INT0600220

Device Problem Incorrect Device Or Component Shipped (2962)

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

Event Date 10/21/2014

Event Type  malfunction  

Event Description

At the time of surgery, the surgeon discovered that implant kit serial number (b)(4) was provided with the incorrect tibial tray (tibial tray serial number (b)(4)).The surgeon decided to complete the surgery using a tibial implant from a different manufacturer.

Manufacturer Narrative

At the time of surgery, the surgeon discovered that implant kit serial number (b)(4) was provided with the incorrect tibial tray (tibial tray serial number (b)(4)).The surgeon decided to complete the surgery using a tibial implant from a different manufacturer.The surgery associated with tibial tray serial number (b)(4) was not impacted.This incident does not necessitate a field action because there are no units to retrieve from the field and no units implanted.Tibial tray serial number (b)(4) was discarded at the time of surgery.Tibial tray serial number (b)(4) was not released to the field.

• Brand Name: IUNI G2
• Type of Device: UNICONDYLAR KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS; 28 crosby drive; bedford MA 01730
• Manufacturer Contact: katrina snow ; 28 crosby drive; bedford, MA 01730 ; 7813459195
• MDR Report Key: 4270169
• MDR Text Key: 17696436
• Report Number: 3004153240-2014-00154
• 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: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2015
• Device Catalogue Number: M5722INT0600220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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: 41 YR