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Information on Hip Implant and Orthopedic device recalls and lawsuits. 866-761-1385.

Information on Hip Implant and Orthopedic device recalls and lawsuits. 866-761-1385.

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    Hip implants Hip implants Document Transcript

    • About Metal-on-MetalContact Michael H. Monheit,Esquire Hip ImplantsEmail:mmonheit@anapolschwartz.com CONTENTSToll Free: (866) 735-2792 Bad News: DePuy Hip Implant Recalls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 FDA Medical Device Report For The Wright Conserve Hip . . . . . . . . . . . . . . . . . . . . . . 3Read more information online at: High Risk Broken Hip Implant Injury . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4www.anapolschwartz.com Wright Metal on Metal Hip Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Marketing, Clinical Trials for Wright Hip Resurfacing System . . . . . . . . . . . . . . . . . . . . 5© 2012 All Rights Reserved. What is the performance of the CONSERVE Plus Total Hip Resurfacing system under actual use conditions? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6MEDICAL DISCLAIMER: This PDF DePuy Hip Replacements—Sometimes the Problem Can’t be Fixed . . . . . . . . . . . . . . 6is not designed to and does not provide What a Hip Recall Really Means . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6medical advice, professional diagnosis, Senate Committee Holds Medical Device Safety Hearing . . . . . . . . . . . . . . . . . . . . . . . 7opinion, treatment or services or other- FDA Requests More Info from DePuy and Others About Hip Replacements . . . . . . . . . 7wise engage in the practice of medicine,to you or to any other individual. Please What You Should Know About Conserve Hip Implants . . . . . . . . . . . . . . . . . . . . . . . . 7use this information to help in your Could New Requirements be Ahead for Medical Device Manufacturers?. . . . . . . . . . . 8conversation with your physician. This is When a Recovery From Hip Implant Surgery Is Not Normal . . . . . . . . . . . . . . . . . . . . . 8general information and always seek the Why Did the ASR Hip Fail Me? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9advice of your physician or other quali-fied health provider with any questionsyou may have regarding a medical condi-tion. Never disregard or delay seeking ATTORNEY DISCLAIMER: This PDF is dedicated to providing general public information regarding legalprofessional medical advice or treatment rights. None of the information on this PDF is intended to be formal legal advice, nor the formation of a lawyerbecause of content found in the PDF, or attorney client relationship. Please contact a Lawyer for information regarding your particular case. This PDF iswebsite, or newsletter. not intended to solicit clients outside the states of Pennsylvania, New Jersey, Ohio, West Virginia and Arizona.
    • Metal-on-Metal hip implants (also known While orthopedic surgeons take precautions to try and control how theas MoM) consist of a ball, stem and shell, all ball and socket rub against each other, there is no way to totally avoid the metal particle production. People react differently to these metalmade of metal materials. MoM hip implant particles.systems may be more suitable for youngerand physically active patients because the Over time, metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint. This is some-metal is durable enough to last a long time. times referred to as adverse local tissue reaction or adverse reaction to metal debris. Either of these adverse reactions may cause the MoM hipMoM hip implants were designed implant to become loose or cause pain requiring replacement surgeryto offer these benefits: where the old device is removed and replaced with another one. • Decreased chance of device fracture Patients who have MoM hip implants should be educated by their healthcare team about potential symptoms which might occur after • Decreased chance of dislocation when the surgery which indicate their MoM hip device is not functioning cor- ball of the thighbone or femur slips out of its rectly. Such symptoms include: socket in the hip bone or pelvis • Less total material being removed from the • Pain in the groin, hip or leg ball and socket when rubbing against each • Swelling at or near the hip joint other as compared to other hip implant • A limp or change in walking ability systems Some metal on metal hip implant systems like DePuy ASR™ XL Ac-What are the two types of etabular System and Zimmer Durom® Acetabular Component have voluntarily been recalled. This doesn’t mean that every hip implant isMoM hip systems? bad. Or conversely, if a MoM hip device has not been recalled, that • Traditional total hip replacement implant doesn’t mean it is free of adverse side effects. • Total resurfacing hip implant Patients who have received a metal on metal hip implant should pay close attention to changes in their general well being and let yourBecause the metal ball and the metal cup slide healthcare professional know if you suffer from any of these ailments:against each other during walking or running, sometiny metal particles may wear off the medical device • Heart—chest pain, shortness of breathand enter into the space around the implant. • Nerves—numbness, weakness, change in vision or hearing • Thyroid—fatigue, feeling cold, weight gainSome of the metal ions from • Kidney—change in urination habitsthe metal implant or fromthe metal particles may evenget into your bloodstream.ABOUT METAL-ON-METAL HIP IMPLANTSCopyright © 2004–2012 All rights reserved. Anapol Schwartz.Read more information online at www.anapolschwartz.com. 2
    • BAD NEWS: DEPUY HIP While many patients will have no problems, they may be haunted by the DePuy hip implant recall. These are the luckier ones.IMPLANT RECALLS Other patients with pain, swelling, and trouble walking will need toDePuy Orthopaedics, a division of Johnson & have additional surgeries to remove the defective hip implant and willJohnson is recalling its ASR™ XL Acetabular Sys- need to find another solution to hip repair.tem (available in the United States) and DePuyASR™ Hip Resurfacing System. Both are hip im- DePuy claims it will pay for reasonable costs but at what cost? Howplants. can you put a price tag on pain and suffering?Every day there are recalls for food, home prod-ucts, cars, diet supplements, and pharmaceutical FDA MEDICAL DEVICE REPORT FORdrugs. But what could be worse than a medical THE WRIGHT CONSERVE HIPdevice recall that is already implanted in yourbody during an invasive surgery requiring painful From August 1997 to November 2011 the FDA received more then 862recovery and a long inopportune rehabilitation? individual reports from people who had used the Wright Conserve Hip.Women of small stature and people with weak Reported events:bones face the highest risk.This hip implant recall means additional testingand monitoring may be necessary to ensure yourhip implant is functioning well. In some cases pa-tients may need additional surgery known as revi-sion surgery. Event Totals:After more than two years of reports about earlyhip implant failure, DePuy Orthopaedics issued a Injury . . . . . . . . . . . 835warning letter to doctors about the medical de- Malfunction . . . . . . 25vice asking for assistance in notifying patientsabout the recall and answering questions that Other . . . . . . . . . . . 2patients might have. The warning comes monthsafter the company announced plans to phase out Complications of Wright Conserve Hipthe product because of slowing sales. Some of the complications experienced after using the Wright Con-What does this mean for hip serve Hip include:implant patients? Grief.At best it means that patients with DePuy hipimplants will have to be tested and monitored.ABOUT METAL-ON-METAL HIP IMPLANTSCopyright © 2004–2012 All rights reserved. Anapol Schwartz.Read more information online at www.anapolschwartz.com. 3
    • Wright Conserve Hip Injuries HIGH RISK BROKEN HIP IMPLANT INJURYAssociated with Many Brands According to a recent study funded by the U.S. National Institutes ofInjuries have been associated with many manufac- Health, older women who break a hip are more likely to die within aturers and brands including Conserve® Total A-class year because of their broken hip. It’s unsettling because the broken hipHead, Conserve® Plus Cup, Conserve® Total Head is the cause of death, not another health condition.W/bfh, Conserve® Plus Ha Cup, Conserve® Total A- And what’s more unsettling is that women are at the highest risk ofclass, Conserve® Super Finish Femoral, M2a Modular dying within the first three months after a hip fracture. Hospitalization,Head Component 38mm Head Diameter, Conserve® surgery, and immobility lead to complications resulting in death.Plus Spiked Cup, M2a Modular Head and M2a 38mmModular Head. As part of a larger ongoing study involving nearly 10,000 women aged 65+, researchers followed 1,116 women who broke a hip and compared them to nearly 4,500 similar women who didn’t break a hip. The study, published in the Archives of Internal Medicine, found that women between the ages of 65 and 69 who break a hip are five times more likely to die within a year than their peers who didn’t suffer a fracture. What is also unsettling is that more adverse side effects are show- ing up in the FDA database for Wright Medical Conserve hip implant cup. A medical device, the hip implant is inserted into the hip ball and socket. Metal on metal implants are supposed to last 15 to 20 years but replacement surgery is now being needed within 3 to 5 years. WRIGHT METAL ON METAL HIP IMPLANTS Metal-on-metal bearings for hip surgery have been in clinical use for more than 20 years, mostly with good results. A small percentage or less than 1 percent of patients may develop inflammation. Lately, a more severe inflammatory response called pseudotumor has been re- ported. A Canadian study was recently conducted to determine the prevalence of pseudotumor following metal-on-metal hip resurfacing in Canadian academic centers.ABOUT METAL-ON-METAL HIP IMPLANTSCopyright © 2004–2012 All rights reserved. Anapol Schwartz.Read more information online at www.anapolschwartz.com. 4
    • The advantages of metal-on-metal hip systems MARKETING, CLINICAL TRIALS FORare to provide hip implant patients with durability,range of motion and joint stability for younger, more WRIGHT HIP RESURFACING SYSTEMactive patients. These metal to metal implants are Here are parts of the FDA’s premarket approval letter dated Novem-made of a cobalt-chrome alloy. The ball and socket ber 2009 for the Conserve Plus Total Resurfacing Hip System made bycan be manufactured to closely match the size of Wright Medical Technology, Inc.the patient’s own joint, allowing for more naturalfunctioning. The CONSERVE® Plus Total Resurfacing Hip System is a single use de- vice intended for hybrid fixation utilizing cemented femoral head com-However, disadvantages and risks include metallic ponent and cement-less acetabular component.debris that might lodge in tissues surrounding thejoint, metallic ions that travel through the body in The CONSERVE® Plus Total Resurfacing Hip System is intended for usethe bloodstream, and possible dislocation of the in resurfacing hip arthroplasty for reduction or relief of pain and/orjoint. Replacement also known as revision surgery is improved hip function in skeletally mature patients having the follow-necessary if there is a problem. ing conditions: • Non-inflammatory arthritis (degenerative joint disease) suchBut back to Canada, nine of the 14 centers that as osteoarthritis, traumatic arthritis, avascular necrosis, orperform metal-on-metal hip resurfacings were sur- dysplasia/developmental dislocation of the hip, orveyed. At the nine centers, 3,432 hip resurfacing • Inflammatory arthritis such as rheumatoid arthritis.surgeries were performed; 76.9% of the patientswere male, the mean age was 51.2 years (range, 16 The CONSERVE® Plus Total Resurfacing Hip System is intended for pa-to 83 years), and the mean body-mass index was tients who, due to their relatively younger age or increased activity28.1 (range, 17 to 55). The mean length of follow- level, may not be suitable for traditional total hip arthroplasty due toup was 3.4 years (range, two to 9 years). A pseu- an increased possibility of requiring future hip joint revision.dotumor developed after four of the 3,432 surgery,for a prevalence of 0.10%. The letter goes on to say that approval is granted but conditions follow such as agreeing to two post approval studies:In conclusion, although pseudotumors remain a con-cern after metal-on-metal hip resurfacing, the preva- Long-term use: This study is designed to evaluate the longer termlence at short to midterm follow-up is very low in safety and effectiveness of the CONSERVE Plus Total Resurfacing Hipthis multicenter survey. Continued close monitoring System. Specific study questions to be answered are:is required to determine what clinical factors are in- 1. What is the longer-term safety performance of the CONSERVEvolved with the uncommon pseudotumor formation. Plus Total Resurfacing Hip System? 2. What is the longer-term effectiveness performance of theHowever, if you are in the percentage of patients CONSERVE Plus Total Resurfacing Hip System?who do suffer from pseudotumors caused by Wrightmetal on metal hip cup implants—the problem is New enrollment study: This study is designed to examine the perfor-real and may require legal intervention. mance of the CONSERVE Plus Total Resurfacing Hip System in newly enrolled patients under real world conditions of use.ABOUT METAL-ON-METAL HIP IMPLANTSCopyright © 2004–2012 All rights reserved. Anapol Schwartz.Read more information online at www.anapolschwartz.com. 5
    • WHAT IS THE PERFORMANCE OF er people have suffered other medical problems, such as heart attacks, that make them reluctant or unable to have surgery because of theTHE CONSERVE PLUS TOTAL HIP risks presented by the anesthesia.RESURFACING SYSTEM UNDER If you received a DePuy A.S.R. hip replacement then it is important toACTUAL USE CONDITIONS? talk to your doctor as soon as possible about your risks and about whatCurrently, the clinical trial is seeking patients who your next steps should be to ensure your safety.have already undergone hip resurfacing in the CON-SERVE Plus IDE. The estimated completion date is WHAT A HIP RECALL REALLY MEANSNovember 2015. You know that feeling of aggravation you have when you open thePatients who already suffer from serious Conserve mail to find a letter recalling your car or appliance? Nobody wants toHip Resurfacing side effects don’t need a clinical deal with the hassle of returning the item to get a new item or gettingtrial; they need legal intervention. an existing item fixed. Even if the company insists that the recall is “free” it still costs you time and energy that could be spent elsewhere.DEPUY HIP REPLACEMENTS— Now imagine that the recall isn’t for one of your goods but instead forSOMETIMES THE PROBLEM a medical implant that is already in your body. The “free” recall now re-CAN’T BE FIXED quires you to undergo another surgery and the risks associated with that surgery. It also requires you to take time away from work, your family, orAn interesting article about the DePuy A.S.R. hip re- the activities that you enjoy. In other words, it is anything but free.placement issue appeared in last week’s New YorkTimes. The article, The Implants Loophole, discussed A recall such as The DePuy Hip Replacement Recall does not fix themany important issues including what the FDA and problem. It doesn’t make up for the harm done. Yet, it is important thatJohnson and Johnson could have done differently to you talk to a doctor about the recall and about how best to protectprevent the problem. your health in light of the recall so that any medical problems can be minimized.However, perhaps the most important part ofthe article is the individual stories it shares aboutpeople who have been affected by a defectiveA.S.R. While DePuy would have you believe thatyou can simply have another operation to fix thedefective device—and that DePuy will pay yourexpenses—it is not always that easy.Some people have such extensive damage to thebone, tissue and nerves in the area of the replace-ment that they are permanently disabled—evenafter a subsequent hip replacement surgery. Oth-ABOUT METAL-ON-METAL HIP IMPLANTSCopyright © 2004–2012 All rights reserved. Anapol Schwartz.Read more information online at www.anapolschwartz.com. 6
    • SENATE COMMITTEE FDA REQUESTS MORE INFORMATIONHOLDS MEDICAL DEVICE FROM DEPUY AND OTHERSSAFETY HEARING ABOUT HIP REPLACEMENTSLast week, the U.S. Senate Special Committee on On May 6, 2011 the FDA asked Johnson & Johnson to provide moreAging held a hearing to look at the FDA’s approval of data about the level of metal found in patients’ blood after hip re-medical devices and the agency’s role in protecting placement operations. Specifically, the FDA is requesting that Johnsonpatient safety as it relates to medical devices. & Johnson, DePuy Orthopedics, Zimmer Holdings and others study the levels of cobalt and chromium for at least 8 years after implant of allThe hearing included testimony about the Govern- metal devices, some of which have already been recalled.ment Accountability Offfice’s (GAO) Investigation intothe FDA’s management of medical device review. Ac- The FDA is requesting this information because of a possible link be-cording to the GAO, concerns remain about the FDA’s tween the metal levels detected in the blood and pain, tissue damageability to assure the public that devices are safe, to and the need for additional surgeries. We will continue to monitor anymonitor devices after they are in the marketplace, and further reports that come from the FDA or hip replacement manufac-to ensure that medical device recalls are effective. turers regarding the results of this data.Also testifying was the lead author of a recent studywhich found that medical device recalls continue to WHAT YOU SHOULD KNOW ABOUTbe a problem in the United States. The study, led by CONSERVE HIP IMPLANTSDr. Diana Zuckerman, was published in The Archivesof Internal Medicine. The study found that in the first In 2009, the Conserve ® Plus Total Resurfacing Hip System was ap-half of 2010 more than 437 million medical devices proved by the FDA. The device is manufactured by Wright Medicalwere recalled by the FDA. That means that in just six Technology, Inc. and is approved to treat fractures, osteoarthritis,months, approximately 1.4 devices were recalled for rheumatoid arthritis and avascular necrosis in hip joints. Since its ap-every person living in the United States. proval, more than 200 adverse event reports have been received by the FDA and lawsuits have been filed alleging that the device failedDuring the testimony, the Senate Committee heard prematurely resulting in harm.the story of a woman who had to undergo a secondhip replacement surgery after her DePuy hip replace- The Conserve device is a metal on metal hip replacement system. Somement was recalled. of the harm that has been allegedly been caused by these devices in- clude:The Chairman of the Senate Special Committee on • Metallosis;Aging has indicated that he is interested in the FDAdeveloping a “more robust post-market surveillance • Biologic toxicity; andprogram” before the Medical Device User Fee and • Early failure rate of the device.Modernization Act comes up for reauthorization in Many of these problems have allegedly been caused by the release of2012. metal particulars from the devices into the patients’ bodies.ABOUT METAL-ON-METAL HIP IMPLANTSCopyright © 2004–2012 All rights reserved. Anapol Schwartz.Read more information online at www.anapolschwartz.com. 7
    • COULD NEW REQUIREMENTS plant failed and that you need immediate medical attention. For exam- ple, the premature failure of metal on metal hip replacement systems,BE AHEAD FOR MEDICAL such as the Wright Medical Technology Inc’s Conserve Hip Implant Sys-DEVICE MANUFACTURERS? tem, can result in metal being released into the blood and surrounding tissue. This can cause significant complications.A new bill was introduced in the United States Sen-ate that would change the way medical implants are If you experience any pain or other unusual symptoms after a Con-monitored. The bill would require medical device serve Hip Implant replacement surgery then please see your doctormanufacturers to track the performance of implants right away for a full examination and treatment plan.after they have FDA approval.The legislation would impact medical implants that WHAT WILL DEFECTIVEare currently approved by the FDA without human ARTIFICIAL HIPS COST US?testing through a process known as the 510(k) pro-cess. Approval via 501(k) requires the manufacturer The problems associated with metal on metal artificial hips are thoughtto prove that its device is substantially similar to one to be among the most significant defective medical device issues of thealready on the market without any human testing. past few decades. As more and more patients come forward with pain- ful and dangerous complications associated with artificial hips fromThe Senators who sponsored the bill believe that the different manufacturers, the cost of the defective products continueslegislation, if passed into law, would allow the FDA to soar.to gather necessary data and protect patients with-out slowing down the initial approval process. Billions in Damages are ExpectedWHEN A RECOVERY FROM Last week, the New York Times* estimated the cost of these defective hip replacements to be billions of dollars in the coming years. TheseHIP IMPLANT SURGERY costs will likely be borne by individuals, employers, insurers and tax-IS NOT NORMAL payers. (*The High Cost of Artificial Hips by Barry Meier, New York Times, December 27, 2011.)Generally, patients undergo hip replacement surgerywith the hope that their quality of life will improve. SHOULD YOU REQUEST THEThey hope to be in less pain than they were in prior NEWEST HIP REPLACEMENTS?to surgery. Maybe not. Newer may not always be better when it comes to medicalWhile pain is normal in the immediate aftermath devices according to a recent study published in a November 2011 edi-of surgery and during the 4–6 week recovery from tion of BMJ. The study found that none of the new hip replacementssurgery, your quality of life should improve after the introduced in the last five years led to better results than hip replace-recovery period. ments that were already on the market and some performed worse.If pain returns or you experience symptoms of infec- The newer hip replacements included the metal on metal hip replace-tion then it is possible that your hip replacement im- ments that are allegedly defective and the subject of many lawsuits.ABOUT METAL-ON-METAL HIP IMPLANTSCopyright © 2004–2012 All rights reserved. Anapol Schwartz.Read more information online at www.anapolschwartz.com. 8
    • As a patient, this information means that you should CONTACT UStalk about your options with your surgeon and agreeon a hip replacement device with which you are both Have you suffered from an artificial hip? Have you been out of workcomfortable prior to surgery. Additionally, it means and in pain? Have you required additional surgeries or suffered perma-you should ask about potential complications and nent complications? If you have then you may be entitled to damagesdiscuss proper follow up care so that any complica- for your injuries.tions can be dealt with promptly. If you or your loved one has endured a MoM hip implant and suf- fered serious side effects or needed a replacement hip—please con-WHY DID THE ASR HIP FAIL ME? tact Anapol Schwartz, a leader in unsafe medical device cases like the MoM hip implant. Talk to a lawyer to find out the facts about yourSince 2008, hundreds of people have asked this very legal options. A medical device lawyer represents the interests of thosequestion. Why did the ASR hip fail? This type of hip who have been harmed by or lost loved ones as a direct result of areplacement failed because its metal on metal de- dangerous medical device. A medical device attorney may representsign may allow metal to be released into the body an individual client or take part in a mass tort action. Call us toll freeand may cause premature failure of the replacement at (866) 735-2792 to schedule a private, no-cost consultation with anhip joint. In other words, the Depuy ASR implant ma- attorney who can evaluate your claim and get your case started.terials, or more specifically the metal parts, are likelywhat is causing ASR hip failures.When Did Depuy ASR Start to Fail?It has been at least four years since the first claims ofDepuy ASR failures have been reported to the FDA.If you have received an ASR hip implant then it is im-portant to talk to your doctor about possible symp-toms of failure and to know what to do when thosesymptoms present themselves.ABOUT METAL-ON-METAL HIP IMPLANTSCopyright © 2004–2012 All rights reserved. Anapol Schwartz.Read more information online at www.anapolschwartz.com. 9