DePuy LPS Femur Replacement Recall Issued Due to Fracture Risk

A recall has been issued for a component that is part DePuy Orthopedic’s Limb Preservation System (LPS), which is designed to replace part or all of the femur.

The DePuy LPS recall was issued for a “Lower Extremity Dovetail Intercalary Component”, due to concerns that it may be prone to fracture and cause severe injury for consumers.  

On August 1, the FDA categorized the action as a Class 1 recall, suggesting that the agency believes the medical device poses a substantial risk of serious injury or death.

The component is used to replace part or all of the femur and the top of the tibia. The recall specifically targets female components, which could fracture at the dovetail when exposed to normal loads caused by walking. The fracture can cause pain, infection, loss of use of the leg, loss of the leg, neurovascular injury and could cause patients to need revision surgery to have the component removed or replaced.

DePuy Orthopedics, a division of Johnson & Johnson, sent out an Urgent Medical Device Recall notice to distributors, hospitals and surgeons that use the device on July 11, warning them that there was a risk of fracture. The company told them to stop distributing or using the recalled components.

The recall affects certain DePuy LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary Components manufactured between February 2007 and May 2013. A complete list of the 32 lot numbers affected by the recall is available in the FDA’s recall notice.

DePuy says it is providing surgeons with a patient letter template to help them notify patients with the component implanted. The medical device company recommends that revision surgery to replace the LPS femur implants that have fractured with another LPS femur replacement is the best treatment option, unless the surgeon determines that it is better to replace it with another commercially available product.

This is not the first DePuy LPS component to be recalled due to fracturing. In February, the FDA announced a DePuy LPS Diaphyseal Sleeve recall after at least 10 reports of problems with that implant, which is used during reconstruction of soft tissue and bony defects in the knee. Six of those reports were of fractures and four were of loosening. That recall was categorized as a class 1 as well.

Consumers or customers with questions can call DePuy’s retail coordinator, Kim Earle, at (574) 371-4917.

DePuy Knee and Hip Recalls and Lawsuits

The recall comes as DePuy Orthopedics continues to faces thousands of product liability lawsuits over problems with certain hip replacement products which have been prone to early failure.

In August 2010, Johnson & Johnson issued a recall for the DePuy ASR metal-on-metal hip system, after registry data suggested that as many as one out of every 8 implants were failing within five years. However, by the time the hip replacement was removed from the market, more than 90,000 of the components were sold worldwide. An estimated 3,500 Irish citizens received ASR implants.

Several thousands consumers have now filed a DePuy ASR hip lawsuit, alleging that the manufacturer designed and sold a defective and dangerous product. At least two cases have already gone to trial in the United States, with one trial in California state court resulting in an $8.3 million damage award and a second case in Illinois state court resulting in a defense verdict.

A large number of similar claims have been filed over problems with DePuy’s Pinnacle metal-on-metal hip replacement, which features a similar design to the ASR. Many of the complaints allege that a DePuy Pinnacle hip recall should have been issued after post-marketing reports made it clear that an unreasonable number of consumers were experiencing similar complications within a few years of surgery.