It’s difficult to contemplate just how a medical device used to rebuild tissues and bones in the knee area could pose life-threatening problems for patients but that is just what has occurred with the DePuy LPS Diphyseal Knee Sleeve.
The urgency of informing patients, physicians and health care professionals about the dangerous side effects that could occur when the devices fail was made clear recently in a nationwide Class 1 Recall Notice issued by the U.S. Food and Drug Administration.
Here’s what FDA officials warned about in their recent recall notice:
“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.”
How serious is the FDA about possible failures of the DePuy Diaphyseal Sleeve? Well, 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.
Such situations are also likely to generate lawsuits and DePuy Knee Sleeve attorneys recently announced that they are now offering free consultations to patients who may have suffered serious health problems when these devices failed.
DEPUY KNEE SLEEVES USED BY SURGEONS
The FDA said the LPS Diaphyseal Sleeve is intended for use with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct 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 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. If a medical facility has the affected product in stock, they are directed to return it to DePuy.
This is not the first time that DePuy Orthopaedics has been in hot water over one of its medical devices. The company also was forced to issue one of the biggest medical device recalls in history a few years ago.
That recall involved thousands of metal-to-metal hip implant systems which the company finally admitted was failing at rates reported as high as 13 percent.
There are currently so many lawsuits over that recall that the federal court system was forced to create a special multi-district litigation coordinated under a single judge overseeing pre-trial evidence-gathering and other legal procedures.
In reading the FDA recall announcement, concerns have been voiced about the fact that DePuy is not recommending revision or additional follow-up in the absence of symptoms of patients with this implanted device.
DEPUY KNEE SLEEVE PROBLEMS
This seems to leave it up to the patients to first develop serious health problems and then come forth for medical treatment. Here are some of the symptoms of problems with DePuy knee sleeves as outlined by the FDA:
- A shift in the positioning of the device’s components
- Loosening, bending, cracking, fracture, deformation or wear of one or more of the components
- Bone fractures
- Possible loss of limb
- Decreased range of motion
- Lengthening or shortening of leg
- Flexion contracture
The FDA said that it has so far 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.