VISIONAIRE TIBIA GI V0100021

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-03-17 for VISIONAIRE TIBIA GI V0100021 manufactured by Smith & Nephew, Inc..

Event Text Entries

[1953561] It was reported that the device did not fit correctly and extended surgery time by 30-60 minutes.
Patient Sequence No: 1, Text Type: D, B5

[8837190] (b)(4).
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1020279-2011-00084
• MDR Report Key: 2022627
• Report Source: 07
• Date Received: 2011-03-17
• Date of Report: 2011-03-17
• Date of Event: 2011-02-22
• Date Mfgr Received: 2011-02-28
• Date Added to Maude: 2011-03-18
• 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: MR. JERRY HOWARD
• Manufacturer Street: 1450 BROOKS RD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal: 38116
• Manufacturer Phone: 9013996153
• Manufacturer G1: SMITH & NEPHEW, INC.
• Manufacturer Street: 1450 BROOKS ROAD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal Code: 38116
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VISIONAIRE TIBIA GI
• Generic Name: VISIONAIRE PROX TIB CUTTING BLOCK - LGNP
• Product Code: EKD
• Date Received: 2011-03-17
• Catalog Number: V0100021
• Lot Number: PM020931V1
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMITH & NEPHEW, INC.
• Manufacturer Address: 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2011-03-17