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Defective Products

Debilitating Problems with DePuy Synthes Attune Knee Implant System

Total knee replacement

An estimated 4.4 million Americans are living with artificial knee implants reports Consumer Safety Watch. For about 90% who have a total knee replacement, it is a very successful surgery – relieving the pain, enabling patients to return to work and improving quality of life. However, for some, the procedure isn’t quite so successful.

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Zimmer Ordered to Pay $2 Million in Hip Implant Case

Zimmer hip implant case

In a March 31, 2017 ruling, Zimmer was ordered to pay more than $2 million to a New Mexico man for a defective hip implant with an “unreasonably dangerous design.”

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FDA 501(k) – aka, Substantially Equivalent

FDA Pre-market approval

Products such as new drugs and complex medical devices must be proven safe and effective before companies can put them on the market.

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Monsanto Roundup Lawsuits Centralized in MDL

Tractor spraying herbicide

In October 2016, a panel of federal judges created MDL No. 2741 to centralize dozens of Roundup lawsuits in one federal court, the U.S. District Court for the Northern District of California under Judge Vince Chhabria.

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FDA Class I Recall: Zimmer Biomet Comprehensive Reverse Shoulder Implant

Zimmer Biomet Comprehensive Shoulder Replacement

February 15, 2017, the FDA announced a Class I recall of the Zimmer Biomet Comprehensive Reverse Shoulder implant because these devices are fracturing at a higher rate than stated in the labeling. If this occurs, patients may need a revision surgery to remove or replace the device.

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Gaining Market Approval for Medical Devices

FDA Market Approval

It is the responsibility of manufacturers to ensure the products they bring to market are safe for public use. While the US FDA reviews the products before going to market, what do medical device manufacturers do to gain market approval?

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Do IVC Filters Make a Difference?

IVC Filter lawsuits

A new study, published in the scientific journal, JAMA Surgical on September 28, 2016, suggests that IVC filters may not help people who are at risk of dangerous blood clots to improve their chances of survival.

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FDA 101: Product Recalls

FDA 101 Product Recalls

Unfortunately, in recent years, drug and product recalls have become more common. Why? What happens and how does the process work? Who is responsible for making sure these products are adequately tested before hitting the market?

Questions? Our knowledgeable staff is available at (877) 284-6600.

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Record $1 Billion Verdict in Pinnacle Hip Replacement Trial

gavel and scales of justice

Yesterday, a federal jury in Dallas, TX, awarded a record $1 billion verdict against Johnson & Johnson and its DePuy Orthopaedics unit to six plaintiffs injured by the company’s Pinnacle metal-on-metal hip implants.

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More Issues with Stryker V40 Femoral Heads

ball and socket

Earlier this month, we updated you on a Hazard Alert regarding a taper lock failure for a specific range of LFIT-V40 Metal Heads.

Other serious problems have been reported related to the LFIT-V40 chrome/cobalt heads, which include:

  • Metallossis
  • Catastrophic head-neck dissociation

Our knowledgeable staff is available at (877) 284-6600.

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