Class I Recall Issued for Depuy Surgical Sleeve

The U.S. Food and Drug Administration (FDA) issued a Class I recall—the most serious type—for DePuy Orthopaedics’ LPS (limb preservation system) diaphyseal sleeve. The Johnson & Johnson company’s device is intended for use with the Orthogenesis LPS system, which is an end-stage revision knee product for the reconstruction of severe soft tissue and bony defects. The prosthesis system is designed for the replacement of extensive bone loss in the lower extremity. This loss can be due to tumor, multiple arthroplasty procedures, infection and severe trauma. The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements. According to the FDA, the taper connection of the LPS diaphyseal sleeve to the diaphyseal sleeve base may be insufficient for loads possibly transferred to the junction during normal gait in some patients; a fracture in the sleeve could lead to loss of function or loss of limb, infection, compromised soft tissue or death.

DePuy was aware of a problem with the sleeve. On January 4, the company issued an urgent medical device recall informing hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots, which are any sleeves manufactured from 2008 to July 20, 2012. The company urged medical facilities to return any remaining stock to DePuy.

“As with any joint replacement procedure, there is the potential for the implant to loosen and result in loss of function, pain or other complications,” DePuy spokesperson Mindy Tinsley told Orthopedic Design & Technology. “Specific risks with fracture of the LPS diaphyseal sleeve may include soft tissue and bone damage, infection and, in extreme cases, loss of the limb.”

The FDA has received a total of 10 reports of incidents in which the device has malfunctioned—6 fractures and 4 reports of loosening. Tinsley said that DePuy has received seven complaints of sleeve fracture from among the approximately 270 LPS Diaphyseal Sleeves that were distributed in six countries from 2008-2012.

There has been no recommendation from either DePuy or the FDA for revision surgery or additional follow up for patients who do not display any adverse symptoms. However, DePuy officials encouraged 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 Warsaw, Ind.-based company currently is facing the first of potentially thousands of lawsuits related to its metal-on-metal hip implants, which have allegedly left metal deposits in patients’ bloodstreams and surrounding soft tissue, leading to health complications.