The U.S. Food and Drug Administration (FDA) recently announced a Class I recall of an orthopedic device made by Johnson & Johnson. A Class I recall is the most serious medical device recall, concerning experienced Kentucky recall injury attorneys.
The recall focuses on a device called the LPS Diaphyseal Sleeve, which is used in reconstructive knee surgeries after cases of bone tumor resection, infection, or trauma. According to the FDA, the device is being recalled because the connection between the sleeves and the pace may not be able to sustain the pressures placed upon it by some patients. This weakness in the device can cause serious damage both to the device and to the patient’s knee.
Use of the device may lead to an increased risk of fractures in the device, which may lead to loss of knee function, infection, soft tissue damage, or other disorders. In severe cases, malfunctions in the device can result in the need to amputate the lower leg. If infections or other conditions caused by the device are not adequately treated, serious injury or death may result.
The FDA has received 10 reports of malfunctions related to the device to date, including six reports of fractures in the device and four reports of loosening in the connection between the device’s sleeve and its base. The affected device is manufactured by De Puy, the orthopedic unit of Johnson & Johnson, between 2008 and July 2012. De Puy is already facing multiple lawsuits related to defects in its hip implants.
If you have had a reconstructive knee surgery with an LPS Diaphyseal Sleeve, you may be entitled to financial compensation for injuries you might have suffered.