San Diego, CA (PRWEB) October 09, 2013
Resource4thePeople announced today its latest update for consumers who may have been affected by the Food and Drug Administration recall* of the DePuy Orthopaedics knee sleeves.
"We have been receiving increasing numbers of inquiries from consumers who were unaware that this medical device had been the subject of an FDA recall and the possible side effects as cited by the FDA and DePuy," said Resource4thePeople.
“As a result we are today announcing an update of our consumer information resource center in which details of the FDA recall and other important information about allegations involving the DePuy LPS Diaphyseal Knee Sleeve are now posted.”
These details also include types of knee sleeve failures, symptoms and other important information for consumers who may have been affected by the concerns raised in the FDA recall, said Resource4thePeople.
"We are encouraging all consumers considering a knee operation or those who have had a DePuy knee sleeve implanted to completely familiarize themselves with what the FDA considers life-threatening concerns."
In addition to offering free consultations to consumers seeking information about legal options they may have to seek compensation over allegations of injuries from the DePuy Orthopaedics LPS Diaphyseal Knee Sleeve systems Resource4thePeople also will be reviewing similar claims involving DePuy metal-on-metal hip implant 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.
In the recall notice the FDA said it had notified health care professionals of a Class I recall of the LPS Diaphyseal Sleeve.
"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. "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 FDA said it had, at the time of the recall, 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.
The FDA said the affected devices were manufactured from 2008 to July 20, 2012.
Resource4thePeople is recommending that any consumer who is considering a knee operation or has undergone one involving the DePuy knee sleeve review these concerns.
"Medications and medical devices are constantly under scrutiny from the FDA, which is acting in the interests of consumers and any health concerns, such as a Class 1 recall, should be taken seriously and all consumers should fully inform themselves of the dangers," said Resource4thePeople.
"Our web site is providing an information bank about this recall and those of metal hip implants that were also the subject of a Class 1 FDA recall."
The metal hip implants were the subject of an August, 2010 recall*** in which the FDA said it was reviewing reports that one of the DePuy metal-on-metal hip replacement systems was failing at rates of up to 13 percent in patients who had undergone hip operations.
“The fact that two different medical devices from DePuy have been recalled raises serious questions about the quality and safety of these products and our lawyers will now be offering free consultations to consumers who have allegations of serious injuries or health problems attributed to either product,” said Resource4thePeople.
“Even though the hip devices were recalled over three years ago we are still accepting claims from consumers affected by those problems as well as the more recent cases involving the DePuy knee sleeves.
Class I recalls such as those issued for the DePuy knee sleeve and hip implant systems 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.
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
FDA officials, in their “Reason for Recall” about the knee sleeve 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.
The Resource4thePeople consultations may provide consumers with information about 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 used in numerous operations by surgeons 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.
*http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm340708.htm Feb. 22, 2013