Johnson & Johnson Recalls Knee Device
Johnson & Johnson’s DePuy unit has issued a class 1 recall on their LPS Diaphyseal Sleeve, a device used in reconstructive knee surgery, because the device can fracture, causing serious injury to patients. The FDA has received at least 10 reports of the device malfunctioning.
“The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death,” U.S. Food and Drug Administration.
Details of the Johnson & Johnson Recall
- The LPS Diaphyseal Sleeve is used to aid in reconstructive knee surgery.
- According to the FDA, a break in the sleeve at the joint of the product could lead to serious injuries or death.
- The devices affected by this recall were made by DePuy from 2008 to 2012.
- At this time, DePuy is not recommending revision or follow up surgeries in patients who are not experiencing adverse symptoms.
- The company is urging surgeons to communicate with patients who received these implants and discuss the risk of fracture.
- Patients may also report adverse events or side effects to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Johnson & Johnson’s DePuy Unit Already Facing Lawsuits
This is not the first major recall for Johnson & Johnson’s DePuy Orthopaedics unit. The company recalled thousands of their ASR hip implants due to a high failure rate in 2010. The company is currently facing thousands of lawsuits over injuries related to the recall.
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