FDA Class I Recall As DePuy’s LPS Diaphyseal Sleeve May Not Accommodate Physiologic Loads

In short

The FDA is notifying healthcare professionals of a Class I recall of part of its LPS knee system. 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.

Background

The LPS Diaphyseal Sleeve is 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 FDA has received a total of 10 reports of incidents in which the LPS Diaphyseal Sleeve has malfunctioned. These include 6 fractures and 4 reports of loosening, although it cannot confirm whether these are attributable to the same device design issue.

On Jan. 4, 2013, DePuy issued an Urgent Medical Device Recall informing hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots. Customers were asked to return inventory of the affected product to DePuy.

Unsurprisingly DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device. However the company is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms.

The affected devices were manufactured from 2008 to July 20, 2012.

See the Recall Notice for a list of affected product codes and lot numbers.

Source: FDA