DePuy Orthopedics has recalled the LPS Diaphyseal Sleeve, a component of a knee implant used in the Limb Preservation System (LPS). The company has received 10 reports of the implant fracturing or loosening during normal use. Complications of a fractured DePuy knee implant include severe pain, infection, loss of limb function, amputation 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, 2013 — DePuy Orthopedics and the U.S. Food and Drug Administration (FDA) have issued a Class 1 recall notice for the DePuy LPS Diaphyseal Sleeve because it has been linked to 10 reports of failure — 4 reports of loosening, and 6 reports of fracture.
The following is the FDA description of the problem:
“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 recalled DePuy knee implant is known as a LPS Diaphyseal Sleeve. The device is a component of the “LPS System,” which is a type of orthopedic device used in knee replacement. The recalled DePuy knee implant is used to enhance the fit of the knee replacement with the patient’s femur.
The recalled devices were manufactured from 2008 until July 20, 2012. DePuy first notified doctors about problems with the device in an Urgent Medical Device Recall notification on January 4, 2013.
All lots of the following part numbers are being recalled:
Symptoms of Knee Implant Failure
- Knee pain
- Inflammation or redness in the knee
- Warmth (which may grow worse over time)
- Loose knee joint
- Instability when walking
- Decreased walking ability
- Unusual sounds in the knee (clicking, grinding, etc.)
- Changes in walking ability
I Have a Recalled DePuy Knee Implant — What Should I Do?
If you have a recalled DePuy knee implant, talk to your doctor about your options. If you are not having symptoms of knee implant fracture, loosening, or failure, it is unlikely that you will need revision surgery to remove and replace the knee implant. In the recall notice, DePuy Orthopedics stated that:
“DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device.”
Even if you are not having symptoms, you can still talk to your doctor about the risks of knee implant fracture, symptoms, and what to do if your knee implant fractures or loosens.