On February 15, 2013, the U.S. Food and Drug Administration (FDA) announced a Class I recall of a DePuy Orthopaedics medical device known as the Limb Preservation System (LPS) Diaphyseal Sleeve. DePuy is a subsidiary of Johnson & Johnson.
What Is the LPS Diaphyseal Sleeve?
The LPS Diaphyseal Sleeve is a component of DePuy’s LPS knee replacement. This device is meant for patients who have suffered severe soft tissue or bone loss injuries to their knees. The sleeve is a cone-shaped, porous-coated, titanium alloyed component that is implanted along the shaft of the femur (the “diaphyseal canal”).
LPS Diaphyseal Sleeve Might Cause Life-Threatening Fracture Side Effects
Recently, DePuy discovered that the LPS Diaphyseal Sleeve Base taper connection might not be sufficiently stable to bear patients’ weight as they walk. The result of excessive weight on a Diaphyseal Sleeve could be a fracture, which could cause the following side effects:
- Loss of limb function
- Loss of limb
- Compromised soft tissue
DePuy issued an Urgent Medical Device Recall to hospitals and surgeons on January 4, 2013. It warned them of the device’s dangers, and it ordered them to both cease using LPS Diaphyseal Sleeves manufactured between 2008 and July 2012 and to return any unused units. DePuy did not recommend patients undergo revision procedures, but it requested surgeons inform patients of the potential dangers.
The FDA states that it has received 10 adverse event reports related to the DePuy LPS Diaphyseal Sleeve. Six were due to fractures, and the remaining four concerned implant loosening. On February 22, 2013, the FDA characterized DePuy’s action as a Class I recall, the most serious type of product recall, because there is a reasonable probability that the product will cause serious adverse health consequences or death.
RLG’s LPS Diaphyseal Sleeve Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a LPS Diaphyseal Sleeve lawsuit on your behalf if necessary. RLG will also keep you up to date on any LPS Diaphyseal Sleeve class action lawsuits, FDA LPS Diaphyseal Sleeve warnings, and additional LPS Diaphyseal Sleeve FDA recall announcements. If you or a loved one received an LPS Diaphyseal Sleeve and believe it caused an injury, contact RLG today.