bad medical devices blog

Zimmer Holdings has pulled its Durom cup for artificial hip implants until it can properly train surgeons on the proper implanting techniques.
The New York Times reports a growing number of physicians are receiving patients who’ve been implanted with the Durom cup and experiencing excruciating pain after their surgeries, a time which is supposed to be […]

The Food and Drug Administration has warned Anika Therapeutics about its manufacturing process.
Regulators sent the Massachusetts-based manufacturer of Amvisc, Amvisc Plus, Staarvisc II, Shellgel and Orthovisc a warning letter about its practices on July 2. The company also makes the prescription veterinary medicine, Hyvisc.
It said the devices the company is making are “adulterated” because “the […]

Zimmer Holdings says it will suspend sales of an artificial hip device, a hip socket known as the Durom cup, because doctors have complained the defective hip device has been failing at a high rate. When the device fails, patients then have to undergo replacement surgery.
The New York Times reports that Zimmer says its investigation […]

Some Utah patients who had surgery to repair dislocated shoulders say a product used to control their pain after surgery actually ended up causing a lot more, KSL News reports. Pain pumps have been used in nerves and other areas without any problems at all. But the shoulder joint is a very small space, and […]

A growing number of physicians say the use of adult-sized medical devices, and the lack of child-sized devices, leads to unnecessary deaths.
Only one stent has been approved for use in children since 1989. Cardiologists say they’re forced to either use a non-flexible adult stent on children in need, or create their own device.
Orthopaedic doctors are […]

Life-saving, implanted medical devices can malfunction when their users receive computerized tomography scans, the Food and Drug Administration warned this week.
Devices like pacemakers, cardiac defibrillators and insulin pumps are most likely to malfunction when receiving the highly used CT scan.
Reports of the implanted devices shocking patients or sending inaccurate signals during and following the scan […]

The FDA has reached a settlement Advanced Bionics LLC, a California hearing device manufacturer that makes the HiRes90k Implantable Cochlear Stimulator, over alleged violations of federal law. The alleged violations involved the failure to notify the FDA of a change of outside supplier or vendor, which may have exposed patients to unnecessary health risks, such […]

Medical device maker Zimmer Holdings Inc on Monday announced a recall of a surgical instrument used in implanting its NexGen replacement knee product.
On July 1 the FDA was notified that Zimmer would be recalling the recalled knee implant instrument, called the tibial broach impactor, which is used in minimally invasive surgeries, a company spokesman […]

Patients who underwent surgery at two Duke University hospitals in North Carolina have filed a class action lawsuit against Cardinal Health and a cleaning-materials compnay.
The suit alleges the companies were responsible for the contamination of surgical equipment used at these hospitals in 2004.
It’s believed the cleaning supplies company sold the pair of Duke hospitals barrels […]

A sponsor-investigator failed to get Food and Drug Administration approval for an experimental prosthesis and has been warned by regulators about his practices.
The FDA says Charles Hamlin enrolled 47 people in a trial of a prosthesis. He was supposed to get an investigational device exemption before commencing the trial, but failed to do so.
Patients […]