FDA recalls Johnson & Johnson Orthopedic Device
The Food and Drug Administration issued a Class 1 Recall of the orthopedic device known as the LPA Diaphyseal Sleeve. Manufactured by Depuy, Johnson & Johnson’s orthopedic unit, the LPA Diaphyseal Sleeve is used in reconstructive knee surgery.
Made between 2008 and July 20, 2012 the LPS Diaphyseal Sleeve is a component of DePuy’s LPS knee replacement system. According to the recall, the LPS Sleeve Base taper connection might not be sufficiently stable to tolerate patients’ weight as they walk, thus resulting in an increased potential for fracture. A fracture with the LPA Diaphyseal Sleeve can lead to:
• Loss of function
• Loss of limb
• Compromised soft tissue
According to Reuters, the FDA has received 10 reports of incidents in which the device has malfunctioned. The FDA reports that “Depuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device.”
If you or a loved one received an LPA Diaphyseal Sleeve, while having knee replacement surgery, and suffered a fracture, you may have a legal claim against Depuy. You can contact our law firm for a free consultation at (610) 941-4204 or on our website: www.pbmattorneys.com