Medical malpractice lawyers have recently learned that Smith & Nephew PLC has announced that it will withdraw a metal liner used for its R3 Acetabular System hip replacements from the market. The company said that it is “not satisfied with the clinical results” of the liner because some patients have required an additional surgery to have the liner removed. Smith & Nephew introduced the hip replacement liner in 2009. Since that time, about 7,700 patients have had them implanted. According to Smith & Nephew, patients who have not experienced problems do not need to have the liner removed. The majority of the R3 Acetabular System hip replacement liners were used in stemmed total hip replacements.
Medical Malpractice Lawyers Express Concern Regarding Increasing Hip Replacement Device Recalls
Complaints about failed hip replacement devices have continued to indicate that patients are experiencing serious problems with certain types of artificial hips. In the past two years, the Food and Drug Administration has received more than thousands of reports about popular devices known as metal-on-metal hips, including the A.S.R. or Articular Surface Replacement manufactured by the DePuy division of Johnson & Johnson, the Zimmer Durom Cup, and implants made by Stryker Orthopedics. Smith & Nephew now joins this list with their latest recall.
In many cases, the all-metal devices were sold without testing in patients or without a requirement that producers track their performance. However, complaints from patients indicate many of them had the all-metal hip devices removed because they failed after only a few years. Typically, replacement hips last 15 years or more.
Metal-on-metal hip replacements can cause devastating injuries as many patients have suffered injuries as a result of tiny particles of cobalt and chromium that the metal devices shed as they wear. Common injuries are damaged muscles and other soft tissue, severe inflammation or the need for additional surgery, also called a revision.
Medical Malpractice Lawyers in Philadelphia and New Jersey
The Philadelphia medical malpractice lawyers at Messa & Associates are experienced at handling cases involving medical malpractice cases resulting from medical errors and defective medical devices. Our extremely skilled team of medical malpractice lawyers and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you or a loved one has suffered personal injuries as a result of a medical error, defective medical device or any other type of negligent care received by a medical provider, contact the medical malpractice lawyers of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.
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For years, the FDA has permitted a regulatory loophole under FDA 510(k) which permits the release of new medical devices like the DePuy hip implant, Zimmer NexGen knee implant, and other medical devices, to be placed onto the market without first receiving a comprehensive review by the FDA. How? Because this loophole permits implant manufacturers, like DePuy, to obtain FDA approval if a medical device manufacturer shows that its device is “substantially equivalent” in safety and effectiveness to another FDA approved device.
Recently, the prestigious Washington Post reported on a fairly widespread yet rarely discussed practice of medical device sales representatives to lurk in operating rooms, without patient knowledge or approval, and guide surgeons in the surgical procedure. According to the Washington Post, this practice of sales rep “assistance” is common among medical device companies including Johnson & Johnson, Stryker, Zimmer, and DePuy.
Under this system, all DePuy hip recall patient should have a specific medical record in their chart which will show which DePuy hip implant products where used. Specifically, for DePuy hip recall patients, there should be a label taken directly from the package that was opened up in the operating room and affixed in the chart. This DePuy label should identify the DePuy hip replacement system (e.g. ASL XR, Pinnacle, etc), the model number, and serial number for the DePuy hip implant.
Despite this responsibility, the FDA has not done much regarding the recall since July 17, 2010, the date they posted information on specific recalled devices. The recall contained DePuy
Most DePuy hip recall patients have had a single DePuy hip replacement. However, many times, an orthopaedic patient will require both hips to be replaced in a surgery called a bilateral hip replacement surgery. Unfortunately, for those patients who have had a bilateral hip-replacement surgery with the recalled DePuy hip implant, the recall is twice as troubling because these patients will require more extensive surgery to remove the two DePuy hips.
As a New Jersey and Philadelphia
One of the questions patients have asked is, “What is the defect that is causing these implants to fail?” Not surprisingly, DePuy Orthopaedics is not telling its DePuy hip implant patients anything of substance regarding why these DePuy hip implants are failing and why they have issued this hip recall. But, DePuy won’t be able to keep its secrets for long. Ultimately, because of the lawsuits, DePuy representatives will have to testify, under oath, about the hip recall. Then, DePuy hip implant patients will finally learn the truth. 