On February 15, 2013, the U.S. Food and Drug Administration (FDA) initiated a Class I recall – the most serious type – of the DePuy LPS Diaphyseal Sleeve. The FDA issued the recall after receiving multiple reports of fractures and loosening that involved the sleeve, which is used in reconstructive knee surgery.
If you believe that you or a loved one has received this device, it’s important to act quickly in order to protect your legal rights.
Call Salvi, Schostok & Pritchard P.C., today or complete our online form.
We are currently investigating cases involving the DePuy LPS Diaphyseal Sleeve. We can provide a free review your case and discuss your legal options.
The LPS Diaphyseal Sleeve is manufactured by DePuy Orthopaedics, Inc., a subsidiary of Johnson & Johnson. The device is intended to be used with DePuy’s LPS System in reconstructive knee surgery. The diaphyseal sleeve is supposed to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements, the FDA says.
However, the FDA says it has notified health officials that the sleeve’s taper connection may not be sufficient to accommodate potential physiological loads that may be transferred to the junction during some patients’ normal movement activities.
As a result, the FDS says, the sleeve may fracture at the taper point and lead to:
The FDA says it has received 10 reports of incidents in which the DePuy LPS Diaphyseal Sleeve has malfunctioned, which may all be attributed to the same device design issue. Out of those reports:
The FDA has responded by issuing the Class I recall – a recall used only in situations in which there is “a reasonable probability” that use of the product “will cause serious adverse health consequences or death.” It is the FDA’s most serious type of recall.
According to the FDA, DePuy issued an “Urgent Medical Device Recall” on January 4, 2013. DePuy told hospitals and surgeons to immediately stop distributing or using the recalled lots. Those lots were manufactured and distributed between 2008 and July 20, 2012 and have the
following product codes:
DePuy does not recommend revision or additional follow-up if a patient is not displaying symptoms. However, the company is encouraging surgeons to talk with patients who received these implants to discuss risks associated with them and methods that can be used to identify failure of the DePuy LPS Diaphyseal Sleeve.
At Salvi, Schostok & Pritchard P.C., we suggest that you contact your hospital or surgeon right away if you believe you received this implant as part of your reconstructive knee surgery. We also suggest that you contact our firm immediately to discuss how to protect your rights.
Our firm has secured more than $800 million for our clients, including more than 198 multi-million dollar verdicts and settlements. We are committed to protecting the rights of patients injured by defective medical products.
Schedule a free consultation today by calling our toll-free number or filling out our online form.