San Diego, CA (PRWEB) August 14, 2013
Resource4thePeople announced today that it is encouraging consumers and health care professionals to follow the recommendations of the Food and Drug Administration about reporting alleged adverse events from the DePuy Orthopedics LPS Diaphyseal Knee Sleeve systems.
The knee sleeves were the subject of a Class 1 recall* Feb. 15, 2013 by the FDA over life-threatening problems which the FDA said 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.
"Consumer inquiries over side effects allegedly suffered with the DePuy knee sleeve show that many consumers were unaware the devices had been recalled and even fewer were aware that the FDA has an Adverse Event Reporting Program," said Resource4thePeople.
"Because of this we are encouraging consumers and health care professionals to report such adverse events in order that federal regulators may receive accurate and detailed information about the extent of the problems that caused this recall."
Resource4thePeople also announced that its national network of attorneys is extending the offer of free consultations to consumers inquiring about what legal options they have to seek compensation over allegations involving the DePuy knee sleeve.
In its recall notice, the FDA said health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to FDA either online, by regular mail or by FAX.
Class I recalls such as those issued for the DePuy knee sleeve are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death, the FDA said.
Resource4thePeople also is announcing the success of its new information center for consumers who are interested in allegations involving serious health problems linked to the recall.
Among the features of the new information center is a link to a toll-free number through which consumers may seek the complimentary consultations being offered by the nationwide network of experienced attorneys familiar with the concerns raised by the FDA.
"There have been a substantial number of inquiries about allegations involving the DePuy knee sleeve in just the few weeks since the center was established," said Resource4thePeople.
Included in the information center are details of the FDA's recall announcement and details of some of the serious health problems that are now being investigated by Resource4thePeople attorneys.
Among the DePuy knee sleeve problems being investigated are:
Possible loss of limb
Decreased range of motion
lengthening or shortening of leg
Shifts in the positioning of the device
Loosening, bending, cracking, fracture, deformation or wear of one or more of the components.
FDA officials, in their “Reason for Recall” warned that health complications as drastic as death could occur if the device malfunctions.
“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,” the FDA said in its warning.
“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.”
Resource4thePeople notes that the Class 1 Recall of the DePuy knee sleeves is the most serious type of recall by FDA regulators and patients who may have suffered these dangerous side effects should fully inform themselves about what legal rights they may have to seek compensation in this situation.
The consultations may provide consumers with information about the legal options they may be entitled to in seeking compensation for medical costs, pain and suffering, loss of wages and other costs that may have been incurred.
The DePuy Orthopaedics LPS Diaphyseal Knee Sleeve is described by the manufacturer as an end-stage revision knee device that has been used in numerous operations by surgeons who are reconstructing severe soft tissue and bony defects. The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.
The FDA said in its announcement that 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.
The FDA said it acted after receiving 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.
DePuy has informed the FDA that the affected devices were manufactured from 2008 to July 20, 2012 and that it has recommended that hospitals and surgeons immediately stop distributing or using the recalled lots.
Resource4thePeople attorneys are investigating the following side effects that DePuy has identified as adverse events in connection with the use of the DePuy knee sleeve with the DePuy Limb Preservation System:**
"Some of the most common adverse events associated with the device include a change in the position of the components, loosening, bending, cracking, fracture, deformation or wear of components, fatigue fractions, infection, tissue reaction to wear debris, pain, dislocation, decreased range of motion and loss of limb."
“Patients and health care professionals place their trust in the integrity of medical devices but on some occasions these devices can malfunction,” said Resource4thePeople.