Tagged Articles

device failure 9 articles

Health Officials Issue Alert to Patients About the Risks of IVC Filters

Newfoundland health officials are currently warning patients about the health risks of inferior vena cava (IVC) filters after Health Canada issued an alert regarding the device’s high failure rate. Health Canada’s alert was issued last July after receiving 121 reports of adverse complications such as migrating, tilting, fracture, perforation of organs, and death if the device is left in for more than 30 days. Canada health officials are suggesting that doctors should use clinical studies as a means to collect information to determine the long-term care a patient with this device may need. Both Western and Eastern Health of Newfoundland have identified ... Read More

West Virginia Woman Sues Smith & Nephew for allegedly defective metal hip implant

Anna Raab of West Virginia underwent her first hip replacement surgery in 2010 at a state hospital and received Smith and Nephew Inc.’s Birmingham Hip Resurfacing System — a metal-on-metal design that had been pre-approved by the FDA. After only a month, Raab had to have a revision surgery after she began to experience complications. The surgeon implanted three additional Smith & Nephew components, which are not specifically part of the original BHR system. But when Raab’s complications continued, she went to the University of Pittsburgh for a second revision surgery. She was then advised that her hip implant had ... Read More

Fifteen injuries linked to defective jaw implant; device has been recalled

Certain implants used in adults, children and infants to lengthen and stabilize the lower jawbone or side jaw to correct birth defects or post-traumatic defects are being recalled because the device may reverse direction. To date, this device defect has caused 15 injuries in patients. The recall involves the DePuy Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies). It is also referred to as an External Mandibular Fixator, External Mandibular Distractor and a Bone Plate. Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur, leading to ... Read More

Ireland orders review for all patients with metal artificial hips

Irish health regulators have ordered a major review of all patients with artificial hips made with all metal parts. The order follows an investigation last year by the United Kingdom’s medical devices regulatory agency during which it was recommended that patients with metal-on-metal hip replacement systems be checked on a regular basis for indications of device failure and a type of metal poisoning caused when the device begins to corrode. Traditional hip implants are made with ceramic or plastic parts. A decade ago manufacturers introduced devices made with all metal parts expecting they would be more durable. However, the devices ... Read More

Testimony: Johnson and Johnson ignored warnings that DePuy hip implant was defective

A doctor working as a consultant for Johnson & Johnson warned company executives in 2008 that the ASR hip replacement system made by J&J subsidiary DePuy Orthopaedics was poorly designed and suggested the company slow its marketing of the device until it discovered why the hip implant was hurting so many patients. The warning fell on deaf ears. It wasn’t until two years later, after several other doctor-consultants for the company pressed the issue with J&J that the consumer health care products giant issued a recall of the ASR artificial hip. In that time, literally thousands of patients worldwide underwent ... Read More

FDA proposes requiring makers of metal hips to submit premarket approval applications

The Food and Drug Administration (FDA) is proposing requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval applications in order to assess risks associated with the devices. The proposed order was announced Thursday along with updated safety information and recommendations for patients and health care providers about illnesses and injuries associated with the devices. Metal-on-metal hip replacement and resurfacing systems, unlike traditional hip systems made with ceramic or plastic parts, have a metal ball that moves within a metal socket. This movement can cause bits of metal debris to release into the joint space, causing soft tissue damage ... Read More

FDA warns doctors, patients about risks associated with metal-on-metal hip implants

The Food and Drug Administration (FDA) released updated safety information to patients and health care providers about risks associated with metal-on-metal hip replacement systems and metal-on-metal hip resurfacing systems based on the agency’s current assessment of the implant and results from the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting. The safety announcement advises health care providers to consider the benefit-risk profile of using metal-on-metal hip implants as opposed to an alternative hip system made with ceramic or plastic parts, to inform patients about the risks associated with the all-metal implants, and be aware of risk factors in the ... Read More

Defective devices used in heart surgery recalled

A device used in heart surgeries is being recalled by the Food and Drug Administration (FDA) because there is the potential for the device to fracture during use. If this happens, fragments of the device could fall into the patient’s chest cavity and/or damage the heart tissue. The manufacturer has received two reports of device failure during use that required retrieval of the device fragments from the surgical wound. This recall is classified as a Class 1, which is the most serious type of recall issued by the FDA and involves situations in which there is a reasonable probability that ... Read More

Defective cords on medical devices may cause serious injury, death

The Food and Drug Administration (FDA) is investigating certain types of medical devices made by Hospira Inc. and Abbott Nutrition after 122 reports of sparking, charring and fires from the power cords used with the devices. The announcement follows a recall announcement and FDA warning last August on some medical devices made by Hospira Inc. because of faulty electrical cords that could lead to serious injury or death. The companies’ investigations of these reports determined that the power cords prongs may crack and fail at or inside the plug. The potential risks from these power cord failures include electrical shock, ... Read More