OXINIUM 71343200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2013-09-03 for OXINIUM 71343200 manufactured by Smith&nephew, Inc.

Event Text Entries

[16051790] It was reported that a revision surgery was performed due to dislocation.
Patient Sequence No: 1, Text Type: D, B5

[16508076] .
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1020279-2013-00425
• MDR Report Key: 3323240
• Report Source: *
• Date Received: 2013-09-03
• Date of Report: 2013-08-14
• Date of Event: 2013-08-14
• Date Mfgr Received: 2013-08-14
• Device Manufacturer Date: 2011-03-01
• Date Added to Maude: 2013-09-04
• 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 PHILLIP EMMERT
• Manufacturer Street: 1450 E. BROOKS RD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal: 38116
• Manufacturer Phone: 9013995296
• 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: OXINIUM
• Generic Name: OXINIUM FEM HD 12/14 32MM +0
• Product Code: LPF
• Date Received: 2013-09-03
• Catalog Number: 71343200
• Lot Number: 11CM13357
• 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	71337652	1. Hospitalization; 2. Required No Informationntervention	2013-09-03