San Diego, CA (PRWEB) December 16, 2013
Resource4thePeople today announced its reaction to the latest figures* reported by the U.S. Food and Drug Administration in connection with a nationwide recall of the DePuy LPS Diaphyseal Sleeve.
In a Sept. 24, 2013 update* of the Class 1 Recall issued Feb. 15, 2013, the FDA said it "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."
Class I recalls 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 fact that the FDA has issued its most serious type of recall notice underlines the significant health problems that may result, including, as the FDA cites, the possibility of life-threatening conditions," said Resource4thePeople.
"In response to these figures we have increased the number of attorneys assigned to review allegations from consumers in connection with the concerns raised by the FDA."
Resource4thePeople said that this response will include the continuation of its policy of free consultations to consumers inquiring about what legal options they may have to seek compensation for medical expenses, pain and suffering and other costs in connection with such allegations.
"However, each case is different and there may be legal time limits involved and consumers are advised to contact us as soon as possible in order to preserve all of their legal options," said Resource4thePeople.
The FDA said that on Jan. 4, 2013, DePuy issued an Urgent Medical Device Recall informing hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots and that if a medical facility has the affected product in stock, it should be returned to DePuy.
"DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device," said the FDA. "However, DePuy is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms."
The recall of the DePuy knee sleeves is the second such Class 1 Recall of a DePuy Orthopaedics medical device. DePuy's ASR metal hip implant system was the subject of an Aug. 24, 2010 Class 1 Recall** by the FDA.
The FDA provided the following details in its recall notice involving the DePuy knee 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. 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."
"We urge any consumers who have suffered any of the following medical conditions allegedly as a result of an operation involving a DePuy knee sleeve to take advantage of our complimentary consultations," said Resource4thePeople.
Here is a partial list of the conditions being investigated:
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
Resource4thePeople also has updated its 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 also 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."
The FDA said the affected devices were manufactured from 2008 to July 20, 2012.
"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.
FDA officials warned in their knee sleeve recall 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 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.