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End-Stage Revision Knee Device Recalled
DePuy Orthopaedics, Inc. recalled its LPS Diaphyseal Sleeve which is used in the DePuy LPS Limb Preservation System. This medical product is an end-stage revision knee device that allows surgeons to reconstruct severe soft tissue and bone defects. This knee revision device consists of several components. The recalled component is the diaphyseal sleeve which is intended to enhance the fit and fill of the femoral canal.
January 4, 2013 Urgent Medical Device Recall
On January 4, 2013, DePuy issued an Urgent Medical Device Recall informing hospitals and surgeons to immediately stop distributing or using the recalled lots. The following month, the FDA issued a class I recall of the device. The LPS Diaphyseal Sleeve taper connection may not be sufficient to accommodate potential physiologic loads during normal gait activities. This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or even death. The affected devices were manufactured from 2008 to July 20, 2012.
Device Recall Classified as a Class I Event
The FDA has classified the DePuy LPS Diaphyseal Sleeve recall as a Class I event, the most serious type of recall since it may involve situations in which there is a reasonable probability that the use of these products will cause serious adverse health consequences or even death.
Know and Understand Your Legal Rights
If you underwent knee surgery and the DePuy LPS Limb Preservation System was used, it is important that you know and understand your legal rights. John David Hart is currently investigating potential lawsuits on behalf of individuals who have been implanted with the DePuy LPS Diaphyseal Sleeve, which is used with the DePuy LPS Limb Preservation System. The Law Offices of John David Hart is a group of experienced and dedicated legal professionals working to protect the rights of people wronged by the acts of others. Across the country, the firm represents individuals in cases of catastrophic personal injury, wrongful death, dangerous drugs and medical products, automobile and truck accidents and oil and gas litigation. For more information, please contact John David Hart at 817-870-2102 or johnhart@hartlaw.com or visit www.hartlaw.com.
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