DePuy Orthopedics has announced a Class 1 recall of the LPS Diaphyseal Sleeve, a component of the Limb Preservation System (LPS), after receiving 10 reports in which it fractured or loosened under normal loads. People with a fractured knee replacement may suffer from severe pain, bleeding, infection, loss of mobility, loss of the limb, nerve damage, and revision surgery.
Class 1 DePuy LPS Implant Recall
August 1, 2013 — DePuy has recalled another component of the Limb Preservation System (LPS) — the LPS Lower Extremity Dovetail Intercalary component can fracture under normal loads. Click here to read more.
February 22, 2012 — The U.S. Food and Drug Administration (FDA) has published a Class 1 recall notice of the DePuy LPS Diaphyseal Sleeve because it may not be strong enough to withstand the weight of a patient during normal activities. The FDA has received 10 reports, including 6 reports of fracture and 4 reports of loosening.
“The taper connection of the LPS Diaphyseal Sleeve to the Diaphyseal Sleeve Base may be insufficient for loads possibly transferred to the junction during normal gait in some patients.”
What is the DePuy LPS Diaphyseal Sleeve?
The DePuy LPS Diaphyseal Sleeve is a part of a knee implant called the “LPS System.” It is used in knee replacement surgery, and it is used to enhance the fit of the patient’s femur with the knee replacement. The recalled device was manufactured between 2008 until July 20, 2012.
All lots of the following DePuy LPS Diaphyseal Sleeve products are being recalled:
Symptoms of Knee Implant Failure
- Pain in the knee
- Inflammation or red skin
- Loosening of the knee implant
- Instability in the knee
- Decreased range of motion
- Abnormal sound in the knee implant (grinding, clicking, etc.)
- Abnormal gait or decreased walking ability
I Have a Recalled DePuy Knee Implant — What Should I Do?
At this time, the U.S. Food and Drug Administration (FDA) and DePuy Orthopedics do not recommend undergoing revision surgery unless the patient has symptoms of problems with the defective knee implant. However, patients who are concerned about their recalled knee implant should talk to their orthopedic surgeon about the symptoms of knee implant failure and what to do if the knee implant breaks.
According to the recall notice:
“DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device. 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.”