FDA Requires DePuy ASR Hip Replacement Recall:
The FDA reports a Class 2 medical implant recall for DePuy Orthopedics. DePuy, a subsidiary of Johnson and Johnson, has recalled their ASR hip replacement devices due to a reported high failure rate. Many patients have experienced hip failure soon after implant surgery in cup sizes ranging from 44mm to 70mm. This particular hip prosthesis is a metal-on-metal hip replacement system that was developed in 2005. Orthopedic surgeons have reported problems with the production of metallic debris between the metal ball and metal socket. The metal debris damages soft tissues and causes inflammatory reactions in the joint that leads to bone loss. Surgeons have estimated that one to three percent of all metal-on-metal hip implant recipients may experience problems and possibly need revision surgery due to the presence of metallic debris.
DePuy acknowledges responsibility for these implant abnormalities and are prepared to provide Hip Replacement Settlements. These settlements are meant to cover, orthopedic surgeon visits, exams, revision surgery and other necessary procedures associated with the defective hip implant. It is recommended that you contact a hip replacement attorney before accepting any settlement. It is important that all your rights are protected and that you receive all the benefits you are entitled to through a Hip Replacement Lawsuit. Due to the recent recall, it is expected that many more cases will be filed and investigation will continue by reviewing potential cases of individuals who have experienced hip replacement problems. [removed][removed]
DePuy Accused of Marketing Unapproved Hip Replacement Systems:
Johnson and Johnson have bucked heads with the FDA again in violation of regulations. The FDA issued a warning on August 19th to DePuy about illegally marketing a hip and knee joint replacement system. DePuy has been accused of marketing TruMatch Personalized Solutions System and the Corail Hip System illegally. DePuy was given 15 days to respond to this warning by taking corrective action or provide a reason for why corrective action cannot be taken. The FDA also ordered DePuy to stop marketing both devices. The FDA considers both devices to be unapproved medical devices, until the issue is resolved.
The TruMatch is a system that helps physicians shape a knee replacement implant so that it fits the patient better. The FDA says that DePuy never told them it intended to commercially distribute the product. The FDA also accused DePuy of getting Corail hip implant approval by providing inaccurate information in terms of its design and use. The
FDA approved the Corail hip implant device under the controversial 510(k) premarket approval system. The premarket approval system requires that a medical device be functionally equivalent to a device already on the market. The FDA issued a warning letter to DePuy stating that the brochure listed a number of claims about the device's capabilities and specifications that were never approved.
DePuy appears to have a number of problems with their hip replacement systems. Given that there has been a DePuy ASR hip recall it is expected that more DePuy Hip Replacement Lawsuits will be filed. If you have experienced metal debris problems, improper fit or any other hip implant complication, you may want to contact a hip replacement attorney to inquire about Hip Replacement Lawsuits. You may be entitled to financial compensation. Hip Replacement Lawsuits are currently being filed across the country.