The FDA initiated an “urgent” Class 1 Medical Device Recall of DePuy Orthopaedic, Inc.’s LPS Diaphyseal Sleeve on February 15, 2013. The agency made the recall public on February 22, 2013.
The 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.
This product was recalled because the sleeve to 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.
The agency informed hospitals and surgeons of the problem on January 4, 2013 and asked providers to immediately stop distributing or using the recalled lots. If a medical facility has the affected product in stock, it should be returned to DePuy.
The sleeves were manufactured from 2008 to July 20, 2012. The product codes and lot numbers for the recall are as follows:
1987-20-018; 1987-20-020; 1987-20-024 and 1987-20-028.
DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device. However, DePuy 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 FDA has received a total of ten reports (six fractures and four reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned.
Questions should be directed to DePuy Orthopaedics at 574-372-7136.
I received this implant October, 2010. Second surgery on this implant January, 2012 for parts pulling and ripping the muscle in my thigh. Now it is May 2013 and I am going for a bone scan for pretesting before having another Total Knee Replacement due to as of now, the glue not holding. Whatever else I’m not being told I have no idea, find out more after the scan. Never recommend this.
My wife age 39 at the time had a total knee replacement done in December 2011. Now at 41 she has had nothing but pain and swelling ever since. It is loose and when she moves it you can hear clicking and crunching. The ortho that did the surgery says that this is normal. Really? New parts aren’t suposed to make these sounds. At least not from a mechanics prospective!