DePuy Orthopaedics is recalling the LPS Diaphyseal Sleeve used in knee revision surgery because of a defect that can result in loss of function or loss of limb, infection, compromised soft tissue or death. The recall is classified as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probably that use of the products will cause serious adverse health consequences or death.
The recall involves the LPS Diaphyseal Sleeve intended for use with the LPS System, which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.
The recall was initiated because the sleeve base taper connection may not be sufficient to accommodate potential psysiologic loads that may be transferred to the junction during normal gait activities by some patients.
The Food and Drug Administration (FDA) has received 10 reports (six fractures and fpur reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned. DePuy is informing hospitals and surgeons of the problems and to stop using them immediately.
DePuy is not recommending revision or additional follow-up in patients with the device who are not showing symptoms. However, the company is encouraging surgeons to communicate with patients who received the implants and discuss the risk of implant fracture and symptoms the patient should be aware of.
DePuy, a subsidiary of Johnson & Johnson, manufactures joint replacement and orthopaedic devices. In 2010, the company issued a recall of its ASR hip replacement systems and resurfacing systems after receiving a higher than expected number or reports of premature failure. The recall, which affected an estimated 93,000 people worldwide, led to an investigation of all metal-on-metal hip implants.
DePuy and Johnson & Johnson currently face thousands of lawsuits from people who say the companies knew the devices were defective but continued to market them to doctors and patients.