February 22, 2013 – Johnson & Johnson (J&J) is now recalling an orthopedic knee replacement device due to a potential for fractures, the U.S. Food & Drug Administration (FDA) announced today. The LPS Diaphyseal Sleeve, which was manufactured by J&J’s DePuy orthopedic unit, has been linked to complications including loss of function, loss of limb, infection, compromised soft tissue, and death. The DePuy Knee Replacement Recall Lawyers at Schmidt & Clark, LLP, are currently accepting potential lawsuits on behalf of individuals who suffered severe health complications after being implanted with an LPS Diaphyseal Sleeve.
DePuy Knee Replacement Complications
The DePuy Knee Replacement affected by this recall is used in total knee revision surgeries, and was recalled due to the device’s potential to fracture after being implanted. The FDA reports that the LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be strong enough to support loads caused by routine physical activities in some patients. When the DePuy Knee Replacement fractures, it can lead to complications including:
- loss of function
- loss of limb
- compromised soft tissue
To date, the FDA has received at least 10 reports of DePuy Knee Replacement complications. Specifically, the LPS Diaphyseal Sleeve has been linked to six fractures and four reports of loosening that may be attributed to the same design issue. The DePuy Knee Replacements affected by this recall were manufactured between 2008 and July 20, 2012. This is a Class I recall, the most serious type allowed by law. In addition to the problems with the LPS Diaphyseal Sleeve, J&J is currently facing a slew of DePuy Hip Lawsuits.
Recommendation for DePuy Knee Replacements
Last month, DePuy issued an Urgent Medical Device Recall to hospitals and surgeons informing them of the problems associated with the DePuy Knee Replacement, and to stop using and distributing the LPS Diaphyseal Sleeve immediately. All remaining stocks of the device should be taken out of circulation and returned to DePuy. At this time, the company is not recommending revision surgery or additional follow up in patients who are not experiencing DePuy Knee Replacement complications. However, DePuy has advised surgeons to contact patients who were implanted with the LPS Diaphyseal Sleeve to discuss the potential side effects associated with the device.
Click here to read the official DePuy Knee Replacement recall announcement from the U.S. Food & Drug Administration.