DePuy Orthopedics has recalled two components of the Limb Preservation System (LPS) because they can fracture suddenly during normal walking activities. The recalled components include the LPS Diaphyseal Sleeve and LPS Lower Extremity Dovetail Intercalary Component. If these defective implants break, they can cause excruciating pain, infection, bleeding, nerve damage, loss of limb, disability, and even death.
What is the DePuy Limb Preservation System (LPS)?
DePuy Orthopedics has issued two recalls for components of the Limb Preservation System (LPS), a medical implant that is used in reconstructive surgery in the lower leg — knee replacement, femur replacement, and lower-leg reconstructive surgery. The DePuy LPS is used for people who have had extensive bone loss due to a traumatic injury, infection, or tumor. Unfortunately, several components of the DePuy LPS can fracture during normal walking activities.
DePuy LPS Recalls
- January 22, 2013 — Class I recall of the DePuy LPS Diaphyseal Sleeve
- July 11, 2013 — Class I recall of the DePuy LPS Lower Extremity Dovetail Intercalary Component
DePuy LPS Diaphyseal Sleeve
The DePuy LPS Diaphyseal Sleeve was recalled because the connection to the Diaphyseal Sleeve Base taper connection may not be strong enough to handle normal walking activities. This can result in fracture of the sleeve at the taper joint, which may also lead to loss of function, loss of limb, infection, soft tissue damage, or death. The FDA has received 10 reports (6 fractures and 4 loosened devices) in which the LPS Diaphyseal Sleeve malfunctioned. The affected products were manufactured from 2008 to July 20, 2012.
DePuy LPS Lower Extremity Dovetail Intercalary Component
The DePuy LPS Lower Extremity Dovetail Intercalary Component is intended to replace parts of the femur — including the mid-shaft, top, bottom, total femur, or top of the tibia. The recalled components were manufactured from February 2007 until May 2013. Unfortunately, it can potentially fracture at the dovetail component when exposed to normal physiologic loads while walking. Patients who weigh more than 200 pounds and/or those who have high levels of activity are more likely to fracture the LPS.
What Should I Do?
If you are not having problems, DePuy does not recommend routine revision surgery to replace the LPS. However, it is a good idea to talk to your orthopedic surgeon about the symptoms of a broken implant and what to do if symptoms appear. If you are injured, contact a lawyer at Schmidt & Clark, LLP to learn more about how to seek compensation for your pain and suffering, medical expenses, disability, and more.
DePuy LPS Risks & Side Effects
- Leg swelling, bruising, discoloration
- Loss of function
- Loss of limb
- Neurovascular injury
- Nerve damage
- Limited mobility
- Knee or femur instability