The U.S. Food and Drug Administration (FDA) recalled two knee replacement products—the LPS™ Diaphyseal Sleeve and the LPS Lower Extremity Dovetail Intercalary Component—manufactured by Johnson & Johnson’s DePuy Orthopaedics, Inc. These devices are components implanted along the shaft of a patient’s femur, or diaphyseal canal, during reconstructive knee surgeries in patients with severe soft tissue or bone defects.
The FDA stated that these knee replacement products may not be able to handle the loads transferred to them during normal activities. As a result, the FDA issued two of its most serious Class I recalls, which indicate there’s a reasonable probability that using the products “will cause serious adverse health consequences or death.”
What Are the Health Risks?
The DePuy LPS Diaphyseal Sleeve and Lower Extremity Dovetail Intercalary Component may not be substantial enough to withstand the normal loads placed upon them by knee replacement patients. This can cause a fracture in the knee replacement, which can result in:
- loss of limb use
- loss of limb
- revision or repair surgery
- soft tissue damage
DePuy has encouraged surgeons to talk about the risk of fracture and methods of detecting implant failure with knee replacement recipients who begin experiencing symptoms.
Which DePuy Knee Replacements Were Affected?
The FDA has received reports of DePuy LPS Diaphyseal Sleeve malfunctions for products manufactured between 2008 and July 20, 2012.
On Jan. 4, 2013, DePuy issued an urgent medical device recall that informed hospitals and surgeons to stop distributing or using affected knee replacements and urged medical facilities to return any affected knee replacement products left in stock. All DePuy LPS Diaphyseal Sleeve products have been recalled because all could potentially cause injury.
All lots of the following part numbers were recalled:
In July 2013, the FDA recalled six additional years’ worth of components, manufactured between 2007 and 2013, because of the risk of fracture. For the complete list, see the FDA Class I recall page.
*Cory Watson Attorneys is no longer accepting these cases.