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Introduction Orthopaedic devices represent 12% of all medical device recalls. Products are approved through pre-market approval (PMA) or the 510(k) premarket notification process. No previous evaluation was found in the literature evaluating foot and ankle device recalls. The field of foot and ankle subspecialty has seen a rapid growth in innovation related to implants in recent years. Methods The Food and Drug Administration (FDA) Device Recall database was evaluated for all foot and ankle devices from 2007 through 2017 for the manufacturer, process of approval, type of implant, recall class, dates of initiation and termination of the recall, manufacturer determined reason, quantity affected, and distribution within the United States or internationally. Results A total of 161 products from 33 companies were identified with 158 (98.1%) approved through the 510(k) process. The most common reason for device recall was due to the device breaking intraoperatively or postoperatively. The average length of the recall was 487.5 days. Conclusions Device recall is not an uncommon event with the majority of products approved through the less demanding 510(k) process.
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The structural validity of the Lower extremity functional scale (LEFS), the Visual analogue scale foot and ankle (VAS-FA), and the Western Ontario and McMaster Universities osteoarthritis index (WOMAC...
This article reviews the imaging aspects relevant to ligamentous instabilities of the foot and ankle with a focus on MRI and ultrasound imaging. A pictorial review of the anatomy of the medial and lat...
Avascular necrosis of the foot and ankle is a rare but important cause of pain and functional abnormality. This process may occur in any bone in the foot and ankle; however, it presents most often in ...
Chlorhexidine-based skin preparations are frequently used in orthopaedic surgery. We report 2 recent cases of patients suffering significant allergic reactions to ChloraPrep complicating routine foot ...
Unstable ankle fractures in diabetics with peripheral neuropathy have an increased risk of postoperative complications, often leading to amputation. Primary ankle arthrodesis has been suggested as an ...
The purpose of this clinical trial is to establish equivalence or incremental benefit of the Walkaide device to standard of care Ankle Foot Orthosis (AFO) for patients with foot drop due t...
The present study investigates the minimal important change and validity of foot and ankle measures.
The Aim of Study is Translate and Adapt the Visual Analog Scale Foot and Ankle (VAS-FA) Instrument Into Turkish and Psycho-metrically Test Its Reliability and Validity Among Patients Who Had Foot and Ankle Disorders or Surgery
There have previously been no validated a specific foot and ankle patient-reported outcome measures in Turkish. The Visual Analogue Scale Foot and Ankle (VAS-FA) will translated and adapte...
The study will evaluate whether an experimental medical device that emits a series of brief, intense magnetic pulse will relieve foot pain from Diabetic Neuropathy (DN). The United States ...
Compressive stockings ameliorate functional outcome and quality of life in patients after elective orthopedic foot and ankle surgery. In this randomized controlled trial the investigators ...
Entrapment of the distal branches of the posterior TIBIAL NERVE (which divides into the medial plantar, lateral plantar, and calcanial nerves) in the tarsal tunnel, which lies posterior to the internal malleolus and beneath the retinaculum of the flexor muscles of the foot. Symptoms include ankle pain radiating into the foot which tends to be aggravated by walking. Examination may reveal Tinel's sign (radiating pain following nerve percussion) over the tibial nerve at the ankle, weakness and atrophy of the small foot muscles, or loss of sensation in the foot. (From Foot Ankle 1990;11(1):47-52)
Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.
The molecular designing of drugs for specific purposes (such as DNA-binding, enzyme inhibition, anti-cancer efficacy, etc.) based on knowledge of molecular properties such as activity of functional groups, molecular geometry, and electronic structure, and also on information cataloged on analogous molecules. Drug design is generally computer-assisted molecular modeling and does not include pharmacokinetics, dosage analysis, or drug administration analysis.
Removal of a drug from the market due to a problem occurring in the manufacture or distribution of the product.
The articulations extending from the ANKLE distally to the TOES. These include the ANKLE JOINT; TARSAL JOINTS; METATARSOPHALANGEAL JOINT; and TOE JOINT.
The role of medical devices in healthcare is essential. The diversity and innovativeness of this sector contribute significantly to enhance the quality and efficacy of healthcare. Covering a wide range of products, from simple bandages to the...
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...