I came across this story recently – and a very useful website you might like to take a look at.

http://www.hiphelp.org/mystory.html

here’s a snippet from Lise

In March, 2008, I received a new right hip. It was supposed to be the latest, most innovative hip manufactured by DePuy, a subsidiary of Johnson and Johnson.

I did not know much about joints or hip replacements before this procedure other than they are what “old” people have or those who have over-exercised their joints. I knew I had congenital arthritis from a birth defect known as dysplasia which affects a certain percentage of the population.

I was a dancer, (not professionally, just a passion), former cheerleader, a mom, wife, professional person, business owner,runner, hiker, and gym rat. At about age 49, the arthritis was making itself known to me. Since I am a business owner and now consultant, my livelihood and that of my family depends upon my good health.

I was armed with internet research. I asked my doctor if my device had any recalls or complaints with the FDA. All indications were, this was one of the most successful surgeries in general.

The device, heavily recommend by my physician was a metal on metal hip or MoM implant. It would wear at least 20 years and it is what all baby boomers and professional athletes who needed new joints were receiving (according to my surgeon).

The surgery, if you have ever seen on YouTube, is pretty brutal. They use tools that reside in your garage; hacksaw, drill, hammer and chisels. They dislocated the hip, saw off the head of the joint, ream out the hip socket, drill out the bone marrow in your thigh and tap in a 7 inch (est.) long metal “stake” in your thigh. They put a ball on the end, (metal, ceramic or combination of both), and then put a cup made of metal or plastic in the socket as you would have a ball rolling about in a bowl. They have different size cups and balls for every size but much depends on the skill of the surgeon. You can come out with a limp and face future dislocations, have one leg shorter than the other, or the best and most widely touted case is you will fare better off than you were before and be pain free!

The surgery went as expected. I went home after two days but had significant back pain – unusual for me since I never had any back issues prior to the surgery. I just assumed it was the result of a bad hospital bed.

Read more here http://www.hiphelp.org/mystory.html

Related articles

• The Onder Law Firm Clarifies What the DePuy Hip Recall Lawsuit Settlement Means to Those Who Did Not File (prweb.com)
• US Drug Watchdog Now Urges Recipients Of The Recalled DePuy ASR Hip Implant To Call Them About A Just Announced Settlement If They Are Not Yet Represented By Counsel (prweb.com)
• Johnson & Johnson agrees to pay $2.5 billion to resolve thousands of hip replacement lawsuits (canadianbusiness.com)
• Johnson & Johnson DePuy hip implant settlement reported (lawprofessors.typepad.com)
• J&J to pay $2.5B to settle hip replacement suits (abqjournal.com)
• Meyers & Flowers Announce $2. … (biomedreports.com)
• J&J Said to Reach $4 Billion Deal to Settle Hip Lawsuits (bloomberg.com)
• DePuy ASR Lawsuit News: Wright & Schulte LLC Files Hip Implant Lawsuit on Behalf of Man Who Purportedly Developed Hip Replacement Complications Due to ASR Hip Implant (prweb.com)
• DePuy ASR Settlement Update: Rottenstein Law Group LLP Comments on $4 Billion DePuy Hip Settlement News (businesslawdaily.net)
• J&J to settle hip-replacement suits for $2.5B (thedailyrecord.com)

Andrew Testa for The New York Times

A faulty Articular Surface Replacement, or A.S.R., removed from a patient in 2010.

By BARRY MEIER

Published: November 12, 2013

Related articles

• Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants (nytimes.com)
• J&J Said to Reach $4 Billion Deal to Settle Hip Lawsuits (bloomberg.com)
• Johnson & Johnson DePuy hip implant settlement reported (lawprofessors.typepad.com)
• Johnson & Johnson said to reach settlement for hip-implant suits (denverpost.com)
• Johnson & Johnson Reaches $4 Billion Settlement Over Hip Implants (theatlanticwire.com)
• Johnson & Johnson Investors Sweat, but the Dow Bounces Back (fool.com)
• Johnson & Johnson Offer Two Settlement Deals for the DePuy ASR Hip Replacements (prweb.com)
• Johnson & Johnson said to reach $4 billion accord to settle hip-implant claims (nj.com)
• Johnson & Johnson to pay $4 billion settlement over metal-on-metal hip implants: Report (cbsnews.com)
• DePuy ASR Settlement Update: Rottenstein Law Group LLP Comments on $4 Billion DePuy Hip Settlement News (businesslawdaily.net)

Smith & Nephew Hip Lawsuit News: Illinois Federal Judge Rejects Preemption in Smith & Nephew Hip Replacement Case, Bernstein Liebhard LLP Reports

Related articles

• Smith & Nephew Hip Lawsuit News: Illinois Federal Judge Rejects Preemption in Smith & Nephew Hip Replacement Case, Bernstein Liebhard LLP Reports (prweb.com)
• Smith & Nephew Letter (earlsview.com)
• Biomet Hip Implants Alleged Poor Design Lead to Serious Problems (defectivehips.wordpress.com)
• Stryker Hip Recall Claims Move Forward With Issuance of New Case Management Order in New Jersey Litigation, Bernstein Liebhard LLP Reports (prweb.com)
• Smith And Nephew Unveils New Hip Device (smithnephewhip.wordpress.com)
• $20 Million Lawsuit on Damages from Hip Replacement: Now, AttorneyOne… (prweb.com)
• Increasing Number of Lawsuits for Smith & Nephew (debooramoore.wordpress.com)
• Hip Resurfacing an Alternative to Hip Replacement (hothealthnews.wordpress.com)
• Hip Replacement Recall (ehipreplacementrecall.wordpress.com)

Doc who designed DePuy’s metal hip tells jury he wouldn’t implant the device today

Related articles

• US Drug Watchdog Now Urges All DePuy ASR And Pinnacle All Metal Hip Implant Recipients To Get A Blood Test And To Call Them Before The Time Runs Out To Get Identified (prweb.com)
• DePuy ASR Hip Recall Website Launched by Bernstein Liebhard LLP to Keep Public Apprised of Ongoing DePuy ASR Litigation (prweb.com)
• Peter J. Flowers, Chicago Trial Lawyer Begins Local DePuy ASR Trial (prweb.com)
• DePuy Defective Hip Implant Claims | eLocal (elocallawyers.com)
• DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
• J&J Profit Pursuit Led to Defective Hip, Lawyer Argues – Bloomberg (earlsview.com)
• What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com (earlsview.com)
• DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable (earlsview.com)
• DePuy Pinnacle Hip Lawsuits: Bernstein Liebhard LLP Notes New Order in Federal DePuy Pinnacle Litigation (earlsview.com)
• Business: Washington Post Business Page, Business News (earlsview.com)

Defence minister to sue over ‘toxic’ hip implants that left him with a tumour

• Andrew Robathan was fitted with ‘metal on metal’ implants in 2006
• Developed non-cancerous tumour in the top of his leg
• More than 10,000 people in UK were fitted with the implants

PUBLISHED: 08:49 GMT, 4 April 2013 | UPDATED: 13:55 GMT, 4 April 2013

Action: Armed Forces Minister Andrew Robathan is suing the firm which made metal hip implants that he claims caused a tumour in his leg

Armed Forces Minister Andrew Robathan is to sue a firm that made a ‘toxic’ hip implant which left him with a tumour in his leg.

Mr Robathan, has been left in constant pain and has difficulty even standing for long periods of time after he was fitted with the ‘metal-on-metal’ implant – which tests have showed can become warn down and poison the bloodstream.

The former SAS officer, who served during the first Gulf War, is among tens of thousands of people to receive the implants, which were the subject of a health warning after it was found that tiny metal fragments could break off of them over time.

Mr Robathan had an operation to resurface both of his hips seven years ago, when doctors inserted the ASR Hip System implant which is manufactured by DePuy, a subsidiary of Johnson & Johnson.

He developed a non-cancerous tumour at the top of his leg, and was told by his doctor that it was linked to the implants, the Telegraph reports.

The devices, which have been fitted to around 10,000 British patients, had already been recalled following safety fears by then.

Health watchdogs in 2012 said that those who had been fitted with them should undergo annual medical checks. DePuy had recalled its implants two years previously.

‘At first I was resigned to the fact that something had just gone wrong,’ he told the Telegraph, ‘but I went from being resigned about the situation to being absolutely angry.

Warning: More than 10,000 people in the UK were fitted with the metal-on-metal hip implants (stock picture)

‘I am in contact with lawyers with a view to taking legal action,’ he said.

A DePuy spokesman said the firm regrets the ASR Hip System did not perform as expected for some patients and that it is committed to addressing medical costs directly associated with the recall, the Telegraph reports.

In October 2012 Mr Robathan, who is married with two children, was told to calm down by the deputy speaker after complaining about noise levels from the public gallery in the House of Commons.

Read more: http://www.dailymail.co.uk/news/article-2303817/Andrew-Robathan-Defence-minister-sue-toxic-hip-implants-left-tumour.html#ixzz2Pj8q7ptd
Follow us: @MailOnline on Twitter | DailyMail on Facebook

Related articles

• US Drug Watchdog Now Urges All Metal Hip Implant Recipients Who Have Had Revision Surgeries To Call Them For The Names of Attorneys To Help Them Get Compensated (prweb.com)
• Signs Your Hip Implants Are Hurting You (earlsview.com)
• Common Problems Associated With Titanium Hip Replacements (orthopedics.answers.com)
• US Drug Watchdog Now Urges All DePuy ASR And Pinnacle All Metal Hip Implant Recipients To Get A Blood Test And To Call Them Before The Time Runs Out To Get Identified (prweb.com)
• DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
• Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)
• DePuy Defective Hip Implant Claims | eLocal (elocallawyers.com)
• Metal on Metal Hips – New Video – Lampkin & Co Solicitors (earlsview.com)
• J&J metal hip failed because of toxic debris -expert at trial | Reuters (earlsview.com)

First Federal Stryker ABG II Hip Lawsuit Filed in MA Court

Related articles

• Stryker Rejuvenate Hip Recall Lawsuit News: Updated Information for Stryker Hip Implant Recall Lawsuits In State & Federal Courts, Provided By Alonso Krangle LLP (prweb.com)
• Iowa Resident Brings Suit Against Stryker For Damages Caused By Recalled Hip Implant – News Press Release | PharmiWeb.com (earlsview.com)
• Stryker Revises Estimates Upwards As To Expenses Related To Defective Rejuvenate & ABG II Hips (prweb.com)
• Stryker Rejuvenate and ABG II Hip Stem Problems Addressed in Multi County Litigation (MCL), Patients Urged to Contact Attorney Fred Pritzker (prweb.com)
• Stryker Encourages Monitoring of Australian Rejuvenate and ABG II Hip Recipients – February 25, 2013 (earlsview.com)
• Kelley Bernheim Dolinsky, LLC Files First Lawsuit in Massachusetts Arising out of Stryker … (biomedreports.com)
• Conflict of Interest of “industry experts” – Open letter from Dr Steve to Dr Frick… (earlsview.com)
• Stryker Hip Implant Recall Claims (christopherfearley.typepad.com)
• Stryker Advises Comprehensive Monitoring of Patients with Recalled Hip Implants (nypersonalinjurylawrecord.com)
• Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)

J&J pressured to settle Australian hip lawsuits

Related articles

• DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
• When Doctors Keep Quiet about Dangerous Hip Devices (earlsview.com)
• Pressure rises for settlement of hip implants case (theage.com.au)
• Compensation hopes for faulty hip implant victims (smh.com.au)
• VICTORY FOR MoM Sufferer – Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com (earlsview.com)
• Common Problems Associated With Titanium Hip Replacements (orthopedics.answers.com)
• Learning the Truth About Sulzer Orthopedics (arthritis.answers.com)
• HELLO – Earth to Major Tom – What Planet is this guy on? At trial of Johnson & Johnson recalled hip implants, doctor testifies device wasn’t defective | NJ.com (earlsview.com)
• Signs Your Hip Implants Are Hurting You (earlsview.com)
• Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)

by Bethany Johansson

Our hips are an important part of the human body. A healthy hip not only improves mobility, but can also be crucial when it comes to high quality of life. Unfortunately, over time, many individuals develop arthritis in their hips—which may require artificial hip implantation. While many hip implants last for years, others can become faulty after a few decades’ worth of use. To avoid serious complications, individuals who have undergone hip replacement in the past should be aware of hip pain, decreased flexibility, hip swelling, increased fatigue, and other side effects that suggest your hip implants may be hurting you. This is especially true of specific models of metal-on metal hip implants including DePuy Orthopaedic’s ASR TM total hip system and Zimmer, Incorporated’s Durom Cup.

According to most experts, on-going hip pain is one of the most common symptoms associated with faulty implantation. While this pain may vary in intensity, it often presents as a dull ache—not a sharp stabbing discomfort. In most cases, individuals who are diagnosed with faulty hip implantation experience discomfort in the groin or lower back, in addition to that felt in the hip itself. Individuals who experience this symptom should seek medical attention as soon as possible to avoid further damage to the joint. 

Decreased Flexibility

Flexibility typically refers to the ability of the human body to move and work in the ways in which it was designed. Unfortunately, decreased flexibility is another common sign that a hip implant may have failed. Individuals who suffer from decreased flexibility years after a hip implantation may also begin to notice that the joint in question is stiff and difficult to move. While flexibility exercises and physical activity may be effective at managing some of the symptoms associated with faulty hip implantation, additional therapies—such as medication use or invasive procedures—may also be required. 

Hip Swelling

According to Drug Watch, hip swelling may also indicate potential implantation failure. Depending on the severity of the failure and on-going complications, the severity of the swelling may be quite variable. In most cases, the sooner that hip swelling is identified in patients who have undergone this procedure in the past, the better the final results of provided health care. Consultation with a nurse, physician, or other health care provider during the early stages of hip swelling may mean the difference between prescription medication use and invasive surgery—which in some cases, may be life threatening.

Increased Fatigue

On-going fatigue is a chronic health condition affecting many individuals living in the United States, and for that matter, the world. While fatigue is an everyday occurrence for some people, it may also be a sign of a more serious health problem, such as the failure of a hip implantation. Experts agree that a change in sleep habits is one of the best indicators of hip implantation disturbance or disruption. Those who have noticed a change in their ability to fall asleep or stay asleep over the past few weeks—and cannot identify a legitimate reason for the fluctuations—should seek medical assistance as soon as possible for rapid treatment and care.

About the author:

Bethany Johansson is an avid health writer and landscape photographer. To learn more about her, please visit her on Google+

Related articles

• J&J Failed to Warn of Metal Hip Implant Flaws, Lawyers Argue (earlsview.com)
• When Doctors Keep Quiet about Dangerous Hip Devices (earlsview.com)
• FDA cracks down on all-metal hip replacements (earlsview.com)
• Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)
• Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury (earlsview.com)
• DePuy Pinnacle Hip Replacement Lawsuits: Bernstein Liebhard LLP Comments on New Study Finding that Hip Replacement Failure More Likely in Women (earlsview.com)
• Iowa Resident Brings Suit Against Stryker For Damages Caused By Recalled Hip Implant – News Press Release | PharmiWeb.com (earlsview.com)
• Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants (earlsview.com)
• J&J again recalls thousands of faulty hip implants – US News and World Report (earlsview.com)

Metal on Metal Hips – New Video

Posted by Lampkins Admin on Mar 5, 2013

Related articles

• Inportant information about legal action on metal hip – originally posted – implantsinfo@metalhipproblems.co.uk (earlsview.com)
• Smith & Nephew Hip Implant Patient Diagnosed with Metallosis (earlsview.com)
• FDA cracks down on all-metal hip replacements (earlsview.com)
• Metal-on-metal hip implant risks ‘unique’ – Health – CBC News (earlsview.com)
• Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants (earlsview.com)
• US Drug Watchdog Now Urges All DePuy ASR And Pinnacle All Metal Hip Implant Recipients To Get A Blood Test And To Call Them Before The Time Runs Out To Get Identified (prweb.com)
• DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable (earlsview.com)
• US Drug Watchdog Now Urges All Metal Hip Implant Recipients Who Have Had Revision Surgeries To Call Them For The Names of Attorneys To Help Them Get Compensated (prweb.com)
• Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)
• J&J gambled on hip implant safety, lawyer alleges – latimes.com (earlsview.com)

FDA Safety Communication: Metal-on-Metal Hip Implants

Date Issued: Jan. 17, 2013

Audience:

• Orthopaedic surgeons
• Health care providers responsible for the ongoing care of patients with metal-on-metal hip implants
• Patients who are considering or have received a metal-on-metal hip implant

Medical Specialties: Orthopaedics, General Medicine, Family Practice, Radiology, Radiologic Technology, Clinical Laboratory Managers and Directors

Device:

Metal-on-metal hip implants consist of a ball, stem and shell, all made from cobalt-chromium-molybdenum alloys.

There are two types of metal-on-metal hip implants:

• Traditional total hip replacement systems
• Resurfacing hip systems

Purpose: In February 2011, the FDA launched a metal-on-metal hip implant webpage. The FDA is providing updated safety information and recommendations to patients and health care providers.  This new information is based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting.

Summary of Problem and Scope:

Metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants.

In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect.  Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an “adverse local tissue reaction (ALTR)” or an “adverse reaction to metal debris (ARMD).”

Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery (a surgical procedure where the implant is removed and another is put in its place). Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions).

Presently, the FDA does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects.  In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.

Recommendations for Orthopaedic Surgeons:

Before Surgery

• Select a metal-on-metal hip implant for your patient only after determining that the benefit-risk profile of using a metal-on-metal hip implant outweighs that of using an alternative hip system (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic or ceramic-on-metal).  Factors to consider include the patient’s age, sex, weight, diagnosis, and activity level.
  • Note that a 2012 FDA advisory panel of experts identified young males with larger femoral heads as the best candidates for hip resurfacing systems.
• Inform patients about the benefits and risks of metal-on-metal hip implants, including the risk that the hip implant may need to be replaced. Also discuss the patient’s expectations and review the potential complications of surgery with a metal-on-metal hip implant.
• Pay close attention to patient populations for which metal-on-metal hip systems are contraindicated.  Be aware of the risk factors that may predispose a device to excess wear and early failure.

Additional information on the FDA’s recommendations for orthopaedic surgeons before, during and immediately following metal-on-metal hip replacement surgery can be found in Information for Orthopaedic Surgeons.

Patient Follow-Up

• Follow-up of asymptomatic patients with metal-on-metal hip implants, including physical examinations and routine radiographs, should occur periodically (typically every 1 to 2 years).  If the hip is functioning properly, the FDA does not believe there is a clear need to routinely perform additional soft tissue imaging or assess metal ion levels in the blood.
• Be aware that there are certain patients who are at risk for increased device wear and/or adverse local tissue reactions (ALTR) and should be followed more closely. They may include:
  • Patients with bilateral implants
  • Patients with resurfacing systems with small femoral heads (44mm or smaller)
  • Female patients
  • Patients receiving high doses of corticosteroids
  • Patients with evidence of renal insufficiency
  • Patients with suppressed immune systems
  • Patients with suboptimal alignment of device components
  • Patients with suspected metal sensitivity (e.g. cobalt, chromium, nickel)
  • Patients who are severely overweight
  • Patients with high levels of physical activity.
• Pay close attention to signs and symptoms that may be associated with metal-on-metal hip implants. Please see the website for a list of common ALTRs and systemic symptoms/complications.
• Conduct a thorough evaluation if a patient with a metal-on-metal hip experiences local symptoms such as pain or swelling at or near the hip, a change in walking ability or a noise from the hip joint more than three months after metal-on-metal hip implant surgery.
• Follow symptomatic patients with metal-on-metal hip implants at least every 6 months.

Additional information on the FDA’s recommendations for patient follow-up can be found in Information for Orthopaedic Surgeons.

For additional information regarding soft tissue imaging or assessing metal ion levels, please review the FDA’s recommendations below.

Imaging

For some symptomatic patients with metal-on-metal hip implants, additional diagnostic imaging is required to assess and diagnose soft tissue findings surrounding the implant.  Please be aware of the FDA’s recommendations:

• Consider the benefits and risks of using different types of diagnostic imaging procedures (e.g. MRI with metal artifact reduction, CT, or ultrasound) as well as the availability of specialized radiology expertise when determining the most appropriate imaging modality for each patient.

If you determine that an MRI of a metal-on-metal hip implant patient is appropriate, the FDA recommends the following:

• Consult with the radiologist to evaluate the benefits and risks of utilizing MRI with metal artifact reduction;
• Review the available device-specific labeling from manufacturers for MRI Conditions; and
• Inform the MRI site that the patient has a metal-on-metal hip implant.

For additional information on the FDA’s recommendations about imaging a patient with a metal-on-metal hip implant, please see Imaging Evaluation.

Assessing Metal Ion Levels

Some patients with a metal-on-metal hip implant may have elevated metal ion levels (e.g. cobalt and/or chromium) in their bloodstream.  Several factors can impact the accuracy, reproducibility, and clinical interpretation of metal ion test results.  Please be aware of the FDA’s recommendations:

• The FDA does not believe there is a clear need to routinely check metal ion levels in the blood if the orthopaedic surgeon feels the hip is functioning properly and the patient is asymptomatic.
• Patients with metal-on-metal hip implants who develop any symptoms or physical findings that indicate their device may not be functioning properly, should be considered for metal ion testing.
• If measuring metal ions, consider obtaining and following serial measurements (using the same sample type, the same measurement method, and preferably the same laboratory) in determining metal ion levels in symptomatic patients.
• At this time, the FDA is not recommending a specific metal ion level as a trigger for revision or other medical intervention.  The metal ion concentration values, including increases in metal ion levels over time, should be considered in addition to the overall clinical scenario including symptoms, physical findings, and other diagnostic results when determining further actions.

For additional information on the FDA’s recommendations on metal ion test methods, selecting a test lab and interpreting test results, please see Metal Ion Testing.

Device Revision

The decision to revise a metal-on-metal hip implant should be made in response to the overall clinical scenario. In case of adverse local tissue reactions (ALTR), revision of a metal-on-metal hip implant may have a worse prognosis than revision of other types of bearing surfaces.

In selecting components for revision:

• Consider the benefits and risks of all bearing surfaces for each patient.
• Check the specific device labeling for compatibility of device components.
• If a patient is suspected to have developed metal sensitivity, carefully select the materials of the revision components (potentially avoiding materials with nickel or chromium).

For additional information, please review the FDA’s considerations on device revisions, which includes our recommendation for a retrieval analysis of every failed metal-on-metal hip implant.

Summary of FDA Recommendations for Orthopaedic Surgeons

*For chromium testing, a validated method that resolves potential interferences must be used.  Please reviewFDA’s recommendations for chromium testing.

Recommendations for Health Care Providers:

Metal-on-metal implant patients with systemic symptoms are more likely to visit their primary care practitioner than their orthopaedic surgeon, which makes it important for all health care providers to be aware of metal ion adverse events that may occur in metal-on-metal hip implant patients. Based on case reports, these events may include:

• General hypersensitivity reaction (skin rash)
• Cardiomyopathy
• Neurological changes including sensory changes (auditory, or visual impairments)
• Psychological status change (including depression)
• Renal function impairment
• Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold.

Patients with systemic findings that are thought to be related to a metal-on-metal hip implant should be advised to follow-up with his or her orthopaedic surgeon to determine the appropriate course of action.

For additional information, please review the FDA’s considerations to Health Care Professionals.

Recommendations for Patients Considering Hip Implants:

• Be aware that every hip implant has benefits and risks.
• Discuss your options for hip surgery with your surgeon.

A list of some questions to ask your orthopaedic surgeon can be found in Patients Considering a Metal-on-Metal Hip Implant.

Recommendations for Patients with Metal-on-Metal Hip Implants:

• If you are not having any symptoms and your orthopaedic surgeon believes your implant is functioning appropriately, you should continue to routinely follow-up with the surgeon every 1 to 2 years.
• If you develop new or worsening problems such as pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip), and/or change in your ability to walk, contact your orthopaedic surgeon right away.
• If you experience changes in your general health, including new or worsening symptoms outside your hip, let your physician know you have a metal-on-metal hip implant.

Additional information for patients with a metal-on-metal hip can be found in Patients who have a Metal-on-Metal Hip Implant.

FDA Activities:

The FDA is committed to providing reliable safety recommendations to patients and health care providers about the utilization of these devices.  Recent activities include:

1. On May 6, 2011, the FDA instructed manufacturers of metal-on-metal total hip replacement (THR) systems to conduct postmarket surveillance study of these devices.  Five manufacturers currently market metal-on-metal hip implants in the U.S. and all five have approved postmarket surveillance study plans.  Data from these studies will provide patients and health care providers with additional information about the safety profiles of the implants, including the effect of metal ion concentrations in the bloodstream.
2. On June 27-28, 2012, the FDA convened the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to seek expert scientific and clinical opinion on the benefits and risks of metal-on-metal hip systems. Information from this panel meeting has helped form these recommendations.
3. On January 17, 2013 the FDA issued a proposed order requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval (PMA) applications.  Metal-on-metal total hip replacement systems were evaluated under the 510(k) premarket notification program. Metal-on-metal total hip replacement systems were marketed in the U.S. prior to 1976 legislation that gave the agency premarket authority over medical devices. As “preamendment devices,” they were designated as Class III (higher risk) devices but were regulated under the 510(k) premarket notification program.

Additional information on FDA ongoing activities are provided in FDA’s Role and Activities.

Other Resources:

For additional resources, see Metal-on-Metal Hip Implants: Other Resources.

Reporting Problems to the FDA:

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with a metal-on-metal device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

Reports to the FDA about adverse events related to metal-on-metal hip systems include, but are not limited to: pain, malposition, adverse local tissue reaction, metallosis, hypersensitivity (allergy), loosening, and dislocation.

To help us learn as much as possible about the adverse events associated with metal-on-metal hip implants, please include the following information in your reports, if available:

• Date of implantation
• Date of implant removal (if applicable)
• Clinical cause for revision (if available)
• System components affected by the adverse event.

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) via e-mail at DSMICA@FDA.HHS.GOV or by phone: 800-638-2041 or 301-796-7100.

This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.

Related articles

• FDA cracks down on all-metal hip replacements (earlsview.com)
• Metal-on-metal hip implant risks ‘unique’ – Health – CBC News (earlsview.com)
• DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
• Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)
• Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury (earlsview.com)
• DePuy Pinnacle Hip Replacement Lawsuits: Bernstein Liebhard LLP Comments on New Study Finding that Hip Replacement Failure More Likely in Women (earlsview.com)
• US Drug Watchdog Now Urges All Metal Hip Implant Recipients Who Have Had Revision Surgeries To Call Them For The Names of Attorneys To Help Them Get Compensated (prweb.com)
• US Drug Watchdog Now Urges All DePuy ASR And Pinnacle All Metal Hip Implant Recipients To Get A Blood Test And To Call Them Before The Time Runs Out To Get Identified (prweb.com)
• US Drug Watchdog Now Urges All DePuy Pinnacle Hip Implant Recipients to Call Them For the Names of the Best Law Firms if a Blood Test Reveals Elevated Metal Levels (prweb.com)
• Iowa Resident Brings Suit Against Stryker For Damages Caused By Recalled Hip Implant – News Press Release | PharmiWeb.com (earlsview.com)