DePuy, as it did with the defective ASR hips, circumvented full FDA premarket approval by claiming its DePuy LPS Diaphyseal Sleeve (DePuy knee replacement) was substantially similar to products made decades earlier.
Houston, TX (PRWEB) February 26, 2013
The LPS Diaphyseal Sleeve is used with the LPS System (DePuy knee replacement recall) which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
On Jan. 4, 2013, DePuy Orthopaedics issued an Urgent Medical Device Recall informing hospitals and surgeons of the problem and 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.
On February 15, 2013 the FDA announced a voluntary recall for the LPS Diaphyseal Sleeve (DePuy knee replacement recall), Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. DePuy Orthopaedics states 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.
The FDA has received a total of 10 reports (6 fractures and 4 reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned, according to the FDA website.
"This recall comes as the first of thousands of defective DePuy ASR hip cases are set to be tried. The Merman Law Firm, because of our involvement in the ongoing hip litigation suits, is uniquely positioned to provide the best possible service to those affected by the recent DePuy knee replacement recall, says Derek Merman."
Derek Merman at the Merman Law Firm, principal office in Houston, Texas is currently accepting client inquiries nationally, for people have suffered injury or have symptoms that may be related to a faulty knee replacement device are encouraged to contact the firm at http://www.mydepuykneerecall.com to get a free DePuy knee recall lawsuit review.
"DePuy, as it did with the defective ASR hips, circumvented full FDA premarket approval by claiming its DePuy LPS Diaphyseal Sleeve (DePuy knee replacement) was substantially similar to products made decades earlier. This is the same strategy it used to receive approval to market its defective hips that resulted in more than 10,000 law suits, says Derek Merman."
Following DePuy LPS Diaphyseal Sleeves recall issued by the FDA, surgical implant recipients may be entitled to significant compensation as a result of alleged problems suffered by victims. This is not the first recall from DePuy. Since 2010, the orthopedic device manufacturer DePuy has recalled both the ASR100 and ASR300 hip implant devices for excessive failure rates.
Derek is compassionate with his clients and passionate about his work for the injured and those that have lost loved-ones due to the negligence of others. Derek was raised by his mother on their ranch near Waco, Texas after his father died in a plane accident when he was six-years-old. As a result of that tragedy, Derek has devoted his practice to focusing on defective drugs and product injuries, wrongful-death claims, catastrophic injuries, and admiralty claims. Mr. Merman has helped his clients recover millions of dollars in verdicts and settlements during his career. Damages depend on the facts of the case, but in every circumstance, Derek endeavors to achieve high settlements and verdicts for each and every client.
No matter where you are in the nation, if you have had a joint replacement device such as a knee implant or knee replacement device and have had recent problems of discomfort it is important to choose a lawyer with experience in lawsuits against DePuy. Contact the Merman Law Firm at http://www.mydepuykneerecall.com to get a free DePuy Knee Recall lawsuit review.
*United States District Court Northern District of Ohio Master Docket Number: 1:10-md-2197