IUNI G2 UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-12 for IUNI G2 UNK manufactured by Conformis, Inc..

Event Text Entries

[5468738] It was reported that revision surgery occurred for patient with a unicondylar knee implant due to persistent pain.
Patient Sequence No: 1, Text Type: D, B5

[13064186] It was reported that revision surgery occurred for patient with a unicondylar knee implant due to persistent pain. Device identifying information was not provided. Review of the device history record was not possible as the serial number of the device was not reported.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3004153240-2015-00038
• MDR Report Key: 4606372
• Report Source: 05
• Date Received: 2015-03-12
• Date of Report: 2015-02-02
• Date Mfgr Received: 2015-02-02
• Date Added to Maude: 2015-03-17
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: KARINA SNOW
• Manufacturer Street: 28 CROSBY DRIVE
• Manufacturer City: BEDFORD MA 01730
• Manufacturer Country: US
• Manufacturer Postal: 01730
• Manufacturer Phone: 7813459195
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: IUNI G2
• Generic Name: UNICONDYLAR KNEE REPLACEMENT SYSTEM
• Product Code: OOG
• Date Received: 2015-03-12
• Catalog Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CONFORMIS, INC.
• Manufacturer Address: 28 CROSBY DRIVE BEDFORD MA 01730 US 01730

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2015-03-12