FDA issues Class I recall of DePuy orthopedic device used in knee surgeries

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Depuy Orthopaedics, Inc. LPS Diasphyseal Sleeve, a device used in reconstructive knee surgeries. Depuy is the orthopedics product division of Johnson & Johnson.

Class I recalls are the most serious type of recall and it issued for defective or dangerous consumer products which could cause serious health effects or even death.

The FDA issued the recall after it received reports the device failing in 10 patients. In six of the reported cases, patients suffered a fracture and in four of the patients, there was loosening of the device.

According to the FDA, the connection between the Diaphyseal Sleeve to Diaphyseal Base taper may not be strong enough to bear loads when people are walking. In some cases, the sleeve may fracture which can cause the patient not able to use their limb. Other complications can include infection, damage to the soft tissue and even death.

The FDA recalled the devices which were manufactured from 2008 thru July 20, 2012. For information on the list of product codes and lot numbers in the recall, see the Recall Notice.

What does a Recall Mean?

DePuy issued the Urgent Medical Device Recall on January 4, 2013 which alerted hospitals and surgeons that the product should stop being used immediately. Any products currently in stock are to be returned to the manufacturer.

DePuy does not recommend revision (device replacement) surgery but they are urging surgeons to follow up with patients and discuss the risks involved with the device and what to do in case the patient starts experiencing symptoms of device failure.

Hip Implant Recall
In 2010, DePuy recalled its Articular Surface Replacement (ASR) Acetabular Hip System and ASR Hip Resurfacing System after it received reports for “higher than expected revision rates” for it’s metal-on-metal hip design. Currently there are more than 6,2000 hip replacement lawsuit filed against DePuy due to injuries patients suffered. The first product liability trial is currently underway in Los Angeles.

In the case of the DePuy hip implants, some patients suffered dislocation of the hip, fractures and metallosis due to the metal-on-metal design shedding metallic debris of Cobalt and Chromium in patient’s systems. These metal ions can call tissue death (necrosis) and possibly cancer or heart problems.

Bellevue Law Firm Represents Patients with Failed Orthopedic Devices

Herbert Farber, founder of The Farber Law Group, began representing DePuy hip implant patients in 2011. Because of his own hip replacement surgeries, Mr. Farber is keenly aware of the pain and suffering that victims of the faulty devices have suffered. Mr. Farber has associated in a co-counsel relationship with a leading New York City law firm which allows contact with the top experts in the field yet maintains personal and local representation.

Free Faulty Orthopedic Device Case Review

If you have experienced complications after a orthopedic surgery, you may be seeking legal remedies for your medical costs and for your pain and suffering. The Farber Law Group will provide a free and confidential case evaluation. We recommend the following:

  • Do not sign anything from a medical device company until you have consulted with an attorney.
  • Do not speak with representatives of DePuy or their representatives or provide information over a “helpline.”
  • Do not sign away access to your private medical records.
  • Seek a second medical opinion.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group.

Contact us today toll free at 1-800-244-9087 or use our Contact Form.

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