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DePuy Orthopaedics 271 articles

Design flaws uncovered with more DePuy metal hip implants

Design defects with metal-on-metal hip implants made by Johnson & Johnson subsidiary DePuy Orthopaedics are in the spotlight again, this time for “size” issues that are allegedly causing pain and injuries, according to an investigation by The Telegraph. The company says that there was an “error in the measuring techniques” with its metal hip implants manufactured at a DePuy plant in Yorkshire, United Kingdom, and that this design flaw could contribute to adverse events experienced by patients. The company said it removed the equipment causing the problems, though it did not say when it discovered the problem or how it ... Read More

Man blames bizarre symptoms on corroding metal hip implant

Howard Piper remembers the overwhelming fatigue that first hit him in 2011. He was driving when he was overcome with exhaustion, and plowed right into the path of an oncoming car. Luckily, no one was injured in the crash, but Howard was baffled by his sudden and overwhelming bout of fatigue. It was just the beginning of strange symptoms that would plague him for years to come. The fatigue became chronic, and he also became irritable and began suffering from tinnitus, a bothersome ringing in the ears. He eventually discovered the cause of his problems – his artificial metal hip ... Read More

Medical device makers offering guarantees to some hospitals

Medical device manufacturers, facing an uphill battle to win the confidence of patients and physicians, are making deals with hospitals to compensate them in the event a device fails to perform as expected. Device makers including Medtronic, Johnson & Johnson, and St. Jude Medical are among the first to offer guarantees on some of their devices. These promises include offers to share in the cost of follow-up treatments, and are a starting point of sorts for manufacturers to start taking responsibility – and more financial risk – for devices that are found to be subpar. Hospital officials aren’t easily wooed, however. ... Read More

Wright Medical to pay $4.5 million for artificial hip manufacturing defect

A Los Angeles County Superior Court jury slapped Wright Medical Technology Inc. with a $4.5 million judgment in a lawsuit that alleged defective manufacturing of the company’s Profemur R artificial hip implant caused injuries. Wright Medical faces more than 1,000 lawsuits over faulty hip implants. The Profemur R case was different from others because it involved a particular component. In that case, plaintiff Alan Warner claims he received the Profemur R implant in 2007 as a replacement to a previous artificial hip. Three years later, he was experiencing severe pain. Doctors discovered that the laser etching in the manufacturing of the ... Read More

European health officials warn of dangers with metal hip implants

Regulators of European medical devices have released a fact sheet detailing the pros, cons and potential health risks for patients who choose to receive so-called metal-on-metal hip implants. The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks compiled the fact sheet to address concerns about premature failures and injuries caused by the all-metal devices. Traditional hip replacement systems are made of ceramic or plastic parts, and can last up to 20 years or longer. But in recent years manufacturers have produced hip implants made with metal parts under the guise that all-metal hip implants would be more ... Read More

Defective metal hips once considered ‘best scientific solution’

Manufacturers of a metal-on-metal hip replacement system that injured tens of thousands of patients considered the defective metal hips to be “state-of-the-art” and “the best scientific solution available,” until adverse events showed the devices were failing miserably. Johnson & Johnson unit Depuy Orthopaedics introduced the ASR Acetabular hip implant in 2004. The device was considered revolutionary because unlike traditional hip implants, which are made of plastic or ceramic parts, the ASR was designed with all metal parts intended to be more durable and last longer than the 20 years typically given for traditional implants. Within five years, however, the Food and Drug Administration ... Read More

More patients eligible for metal-on-metal hip injury compensation

An additional 1,400 patients who had received a DePuy ARS metal-on-metal hip implant are now eligible to participate in the U. S. Settlement Program to receive compensation for their revision surgeries. DePuy Orthopaedics, a subsidiary of Johnson & Johnson, announced that it has agreed to extend the existing U.S. Settlement Program to include eligible patients in the U.S. who had surgery to remove and replace their defective implants after Aug. 31, 2013 and on or before Jan. 31, 2015. The previous settlement, announced in November 2013, did not compensate eligible patients who had revision surgery after Aug. 30, 2013. The agreement ... 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