On February 15, 2013, the U.S. Food and Drug Administration (FDA) initiated a Class I recall – the most serious kind – for certain lots of the DePuy LPS Diaphyseal Sleeve that were manufactured between 2008 and July 20, 2012.
This device is made by DePuy Orthopaedics, Inc., a subsidiary of Johnson & Johnson. It is used in reconstructive knee surgery.
The FDA says it issued the recall notice due to the possibility that the device’s sleeve-to-sleeve base taper connection may not be able to accommodate potential physiologic loads during normal movement by some patients. As a result, the sleeve may fracture at the taper joint, possibly leading to loss of function, loss of limb, infection, compromised soft tissue or death.
The FDA says it has received 10 reports involving the device, including fractures and loosening.
DePuy has warned hospitals and surgeons to immediately stop distributing or using recalled lots of the DePuy LPS Diaphyseal Sleeve. This action may be too late for those who have already suffered harm.
If you or a loved one has received this implanted device, talk to your doctor and The Driscoll Firm, LLC, right away. We take on defective medical manufacturers and work hard to secure compensation for victims.
We can provide a free consultation and discuss explore your legal options. We charge nothing for our services until you recover the full compensation you deserve.