San Diego, CA (PRWEB) July 19, 2013
Resource4thePeople announced today that it has established a new information center for consumers who are interested in allegations involving serious health problems linked to a U.S. Food and Drug Administration recall* of DePuy knee sleeves.
Among the features of the new information center is a link to a toll-free number through which consumers may seek complimentary consultations from a nationwide network of experienced attorneys familiar with the concerns raised by the FDA.
"We are making this announcement because there has been a substantial increase in the number of inquiries from consumers who are attempting to determine whether they may be eligible to seek compensation in connection with alleged health problems they suffered as a result of a DePuy knee sleeve," said Resource4thePeople.
"The allegations stem from serious concerns raised by the FDA in a Class 1 Recall which warned that the DePuy Orthopaedics LPS Diaphyseal Knee Sleeve may fail and cause life-threatening consequences."
Included in the information center are details of the FDA's Feb. 22, 2013 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
- Flexion contracture
- Bone fractures
- Shifts in the positioning of the device
- Loosening, bending, cracking, fracture, deformation or wear of one or more of the components.
"The side effects that the FDA warns about in its recall notice reflect life-threatening allegations that involve medical conditions that our attorneys are actively seeking compensation for on behalf of our clients," said Resource4thePeople.
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.”
“The increase in the inquiries we have been receiving from consumers who may have been affected by this recall centers on questions about what legal compensation they may be eligible to receive," said Resource4thePeople.
“This is the most serious type of recall by FDA regulators and we are encouraging patients who may have suffered these dangerous side effects to 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 issued the Class 1 Recall of the DePuy Orthopaedics LPS Diaphyseal Knee Sleeve in an urgent notification to health care professionals and consumers.
The FDA in the announcement describes Class I Recalls as 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 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.
DePuy also recalled*** thousands of its metal-on-metal hip implant systems in 2010 and thousands of DePuy metal-on-metal hip implant lawsuits have been filed by patients alleging injuries in a federal court system multi-district litigation.****
Bloomberg News, in a Jan. 18, 2013 analysis***** of the litigation, said that DePuy’s parent company, Johnson & Johnson is defending itself against more than 10,000 lawsuits over the recalled hip implants and may face over $2 billion in legal costs.
*http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm340708.htm Feb. 22, 2013
**** DePuy Orthopaedics Multidistrict Litigation # MDL 2197 U.S. District Court, Northern District of Ohio