The United States Food and Drug Administration (FDA) recently issued an urgent recall of the LPS Diaphyseal Sleeve knee replacement device manufactured by DePuy Orthopedics, a subsidiary of Johnson & Johnson. The LPS Diaphyseal Sleeve was marketed from 2008 through 2012 and was placed along the shaft of a patient’s femur (diaphyseal canal) during reconstructive knee surgeries in patients having severe soft tissue or bony defects.
The problem with the diaphyseal sleeve was that it may not be able to handle the physical loads placed upon it during normal activities; the FDA has received reports of fractures occurring at the “base taper joint,” the weakest point of the structure. Fracture of the device can result in:
- soft tissue damage,
- necessity for repair surgery,
- loss of limb,
- or even death.
DePuy Orthopedics has encouraged surgeons to talk about the risk of fractures and methods used to detect failure of the implant, with their patients who are experiencing symptoms. At this point, the company is not recommending any action for patients who have received the recalled knee implant but have not experienced any symptoms.
On January 4, 2013, the FDA issued a Class 1 recall of the devices. A Class 1 recall is the most serious type of recall, meaning that in the FDA’s estimation there is a reasonable probability that use of the product “will cause serious adverse health consequences or death.” All lots with the following part numbers are being recalled:
If you or someone you know suffered serious adverse health effects after receiving a DePuy knee replacement, Martin & Jones may be able to help you obtain compensation. Just call 800-662-1234 for a free consultation.
DePuy LPS Diaphyseal Sleeve™ is a registered trademark of DePuy Orthopedics, Inc., DePuy International, and Johnson & Johnson, and is used here only for the purporse of identifying the product in question.