02/25/2013 FDA Recall likely to lead to Depuy Knee Lawsuit: FDA announces DePuy Knee Class 1 recall. According to the FDA the DePuy LPS Diaphyseal Sleeve recall may be defective, potentially unable to withstand weight bearing loads typical of normal gait activities and could result in infection, amputation or death. The class one DePuy LPS Diaphyseal Sleeve recall was announced February 22, 2012.
This important notification should be evaluated by all individuals that believe they may have received a DePuy knee implant and LPS Diaphyseal Sleeve. The consequences of the failure of a LPS Diaphyseal Sleeve can be potentially serious or even deadly. Consumers are urged to seek medical immediate intervention is symptoms of possible defect occur. Legal rights also need to be protected as financial assistance potentially associated with medical costs and/or pain and suffering may be potentially available.
What can potentially happen if the product fails? The FDA DePuy LPS Diaphyseal Sleeve recall notification, published on 02/22/2012 warns “The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. 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 death.”
What is a class 1 DePuy knee recall? The DePuy knee recall is a class 1 recall and a class 1 recall is defined by the FDA as “Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Why did the FDA issue a class 1 DePuy knee recall ? The Food and Drug Administration (FDA) has an Adverse Event Reporting System available for consumers and healthcare professionals to use to report problem with medical devices or drugs. Even though some consumers and healthcare professionals are not aware of the system, it has shown some success in alerting the FDA to problems associated with potentially defective drugs medical devices such as the DePuy LPS Diaphyseal component of an artificial knee implant.
According to the DePuy Knee recall notification “The FDA has received a total of 10 reports (6 fractures and 4 reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned.”
For additional information about the class 1 DePuy recall, please contact your doctor, visit the FDA’s website or speak with a DePuy knee recall lawyer.