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ASR 71 articles

Small-Head Metal-on-Metal Hip Implants Fail Frequently

Large-diameter metal-on-metal hips were thought to be an independent risk factor in hip failure, besides the material from which the prosthetic was made. But according to a recent study, adverse reactions to metal debris from small-headed metal-on-metal Articular Surface Replacement (ASR) hips are even more common than originally thought. In the study, 482 hips (424 patients) were reviewed. After the ASR small-diameter hip was recalled at an average of 4.9 years post-op, 379 patients (435 hips) agreed to a screening that measured cobalt and chromium in the blood. Metal-on-metal hip implants are created with a ball-and-cup design made up of a cobalt-chromium ... Read More

U.S. Judicial Panel on Multidistrict Litigation Assigns New Judge to DePuy ASR Hip Implant MDL

Judge David A. Katz of the U.S. District Court for the Southern District of Ohio, who has been presiding over the ongoing DePuy Orthopaedics Inc. ASR Hip Implant Products Liability Litigation docket from the beginning in December of 2010, passed away in July at the age of 82. The MDL has been assigned a new judge by the U.S. Judicial Panel on Multidistrict Litigation. As of Sept. 2, Hon. Jeffrey J. Helmick has been assigned to coordinate pretrial proceedings. According to the New York Times, the ASR metal-on-metal hip made by DePuy Orthopaedics, subsidiary of Johnson & Johnson, has been dubbed “one of the biggest medical ... Read More

Metal-on-Metal Hips Marketed as ‘Better’ Despite Lack of Long-Term Data to Prove It

One of the most successful medical advancements of  the 20th century is the total hip replacement. In 2010 alone, more than 300,000 hip procedures were performed in the U.S. Many materials have been used in hip prosthetics, and metal-on-metal surfaces have been used as early as 1948. Because the metal-on-plastic models have shown to have higher revision rates for younger, more active patients, there has been a push toward reviving metal-on-metal hip implant designs. The metal-on-metal hips showed positive results during early short-term clinical studies. Because of this, orthopedic surgeons readily accepted this modernized version of an old prosthetic and recommended ... Read More

Reactions to Metal Debris Shed by Metal-on-Metal Hip Implants Documented as Early as 1970s

Companies such as Johnson & Johnson and its subsidiary DePuy Orthopeadics; Smith & Nephew; and Wright Medical manufacture metal-on-metal hip implant designs that have been shown to fail at an alarmingly high rate. Metal-on-metal hip implants have been in the spotlight lately for the lawsuits associated with patients claiming to be injured by their faulty design. Reports indicate metal-on-metal designs are failing in as little as five years, and many patients are experiencing adverse affects such as loosening, which is an especially dangerous issue for this design. As the parts of the device rub together during normal activities such as walking or running, the metal parts ... Read More

Metal-on-Metal Hip Implants Referred to as ‘a large uncontrolled experiment’ by BMJ Publication

According to BMJ Magazine, a leading publication about medical news, metal-on-metal hip implants are basically “large uncontrolled experiment” because the patients who received them were kept in the dark about the details and risks of this type of hip implant device. With a metal-on-metal hip device, such as the models made by Johnson & Johnson’s subsidiary DePuy Orthopaedics, and Smith & Nephew, there is great risk in a few areas. First, the large-diameter ball-and-cup designs tend to wear out faster and become dislocated. In fact, the average failure rate at the seven year mark for metal-on-metal implants is 13.6 percent, which is ... Read More

Newer hip implants may not be better than older models

When Dr. Art Sedrakyan and fellow researchers published the first paper on premature failures of metal-on-metal hip replacement systems in 2011, several medical device manufacturers responded by withdrawing their all-metal hip implants. It turned out the failures were caused when the metal parts rubbed against each other, causing metal bits to inflame neighboring tissue and leech into the bloodstream poisoning the blood. “Back in 2011 when we published the first paper on metal-on-metal hips, hundreds of people contacted me and asked if they should be worried about hip replacement in general,” says Sedrakyan, of the Patient Centered Comparative Effectiveness Program ... Read More

Readers warn people with metal hip implants to have their blood checked for metal ions

“If you have a metal-on-metal (hip) replacement, it is imperative to have the metal ion test as soon as possible,” warned BJackson, in a comment on Missoulian’s Letters to the Editor. “My neighbor’s wife passed away a little over a year ago because of cobalt and chromium poisoning. .. she had the offending metal-on-metal (hip implant) removed and a new hip put in, (but) it was too late for her. They had spent three years telling her that she had ALS, but they were incorrect, and it was the metal-on-metal (hip implant) that killed her.” The comment was posted in ... Read More

FDA provides guidance to help medical device manufacturers gain faster marketing approval

The Food and Drug Administration (FDA) is providing manufacturers with information to help them win faster approval for medical devices deemed “substantially equivalent” to other devices, even if the technology of the new device is different or carries different risks. The guidance is designed to prevent defective medical devices from passing through the agency’s abbreviated 510(k) approval process, which allows faster clearance to moderate risk devices if they are similar to other devices currently on the market. The FDA has been revamping the 510(k) process since it was revealed four years ago that the faulty Johnson & Johnson DePuy ASR ... Read More

Johnson and Johnson to pay Oregon $4 million for deceptively marketing metal hip implants

Johnson & Johnson will pay $4 million to settle a lawsuit with the State of Oregon over claims that the company failed to warn doctors and patients that its artificial hip had a high failure rate. The settlement is being called the first of its kind by the Oregon Department of Justice. The settlement involves Johnson & Johnson’s subsidiary DePuy Orthopaedics’ ASR metal-on-metal hip replacement system, which was recalled in 2010 after mounting reports of premature failure. Not only were the devices failing at a higher than expected rate, in some cases the metal devices were corroding inside the body, ... Read More

DePuy settles ASR metal hip complaint before trial start

Johnson & Johnson has settled a personal-injury lawsuit that accused its DuPuy Orthopaedics unit of manufacturing defective metal-on-metal hip replacement devices. The lawsuit had been selected as a bellwether case among several other cases DePuy faces over its ASR hip implants, and was destined for an October 15 trial in San Francisco Superior Court. In March, a Los Angeles jury ordered DePuy to pay Loren “Bill” Kransky, a retired prison guard, $8.3 million in damages for injuries he allegedly received from an all-metal ASR hip device made by DePuy. Mr. Krannsky’s case was chosen as the first of more than ... Read More