The attorneys at Morgan & Morgan investigated lawsuits on behalf of patients who were implanted with DePuy Orthopaedic’s knee Limb Preservation System (LPS), an end-state revision knee device used in patients who have suffered severe soft tissue damage and bone defects as a result of trauma, infection, tumors or multiple joint replacements. The LPS is designed to replace both the knee joint and lost bone in the leg.
FDA Recalls DePuy Knee Joint Component Due to Fracture Risk
In February 2013, the FDA issued a Class I recall – used only when there is reasonable probability that a product will cause serious adverse health consequences or death – for the diaphyseal sleeve used in DePuy’s knee LPS. According to the FDA, the joint part poses a fracture risk, which can lead to serious complications for the recipient. Specifically, the FDA announced that the taper connection between the sleeve and the base may not be able to withstand loads transferred to the joint during normal, everyday movement.Should the sleeve fracture at the taper joint, loss of function, loss of limb, infection, compromised soft tissue or death may result.
DePuy Knee Replacement Problems
Signs of failure may include the following:
- Limited range of movement
- Warm, inflamed or red skin
- Instability in the knee
- Loosening of the knee implant
- Swelling and/or pain in the knee
- Abnormal sound in the knee implant
- Decreased ability to walk
- Abnormal gait
On Jan. 4, 2012, the FDA informed hospitals and surgeons of the potential problem with the sleeve and asked them to stop using the recalled lots. According to the FDA, all diaphyseal sleeves manufactured between 2008 and July 2012 are affected by the recall. To date, the FDA has received 10 reports of device malfunction, specifically related to fracture and loosening of the knee implant.
Medical devices injure thousands of Americans every year. If you have a medical implant, check out classaction.com to stay informed about the latest recalls and legal actions against manufacturers. If you’ve suffered symptoms because of a medical device, contact our class action lawyers today.