DUROFLEX ARTIFICIAL FOOT DURO FLEX UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-10-19 for DUROFLEX ARTIFICIAL FOOT DURO FLEX UNK manufactured by American Prosthetic Components, Inc.

Event Text Entries

[1330446] Pt had surgery in 2009, to amputate right leg below the knee due to diabetes complications. He has a prosthesis for approximately 2 months. Five months later, due to catastrophic failure of his prosthesis, artificial leg collapsed and pt fell forward, struck a 6 foot book case full of dvd's and videos and pulled it down on top of him. Pt also had a puncture wound on the left hand from striking another object and also received an abrasion on the leg stump as well. Prosthesis is rated for weights up to 500 lbs and rated k-2 to k-4. Prosthesis is manufactured by american prosthetic components. The pieces that failed are the heel pin that holds the artificial foot to the artificial leg, the artificial foot itself and the release pin on the leg. The pt states that the "heel pin" snapped causing him to pitch forward and hyper extend the artificial foot causing it to snap it two pieces, then the release pin jammed preventing the release of the artificial leg from the fiberglass cup over the leg stump. Dates of use: 2009. Diagnosis or reason for use: amputation due to diabetes complications.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5013121
• MDR Report Key: 1514233
• Date Received: 2009-10-19
• Date of Report: 2009-10-19
• Date of Event: 2009-10-16
• Date Added to Maude: 2009-10-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• 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: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DUROFLEX ARTIFICIAL FOOT
• Generic Name: ARTIFICIAL FOOT, K-2-K-4 RATED TO 500 LBS
• Product Code: IQO
• Date Received: 2009-10-19
• Model Number: DURO FLEX
• Catalog Number: UNK
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AMERICAN PROSTHETIC COMPONENTS, INC
• Manufacturer Address: 900 ONTARIO RD GREEN BAY WI 54311 US 54311

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2009-10-19