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FDA Warns DePuy Over Hip Implant and Knee Replacement Product

Johnson & Johnson has again run afoul of federal regulators, this time with its medical device subsidiary, DePuy Orthopaedics. The company has been warned recently that it is illegally marketing a hip implant and knee joint replacement product. 

The FDA issued a warning letter to DePuy Orthopaedics, Inc. president David Floyd on August 19, which says that the marketing of the TruMatch Personalized Solutions System and the Corail Hip System are illegal. The Johnson & Johnson unit has 15 days to respond to the letter either by taking corrective action or giving a reason for why corrective action cannot be taken immediately. The company has also been ordered to halt marketing on both products, which the FDA considers to both be unapproved medical devices, until the situation is resolved.

TruMatch, a system that helps doctors shape knee replacement implants to better fit their patients, has not been approved for use in the U.S., according to the letter. The FDA claims DePuy never told them it intended to commercially distribute the product.

The FDA also accuses DePuy of getting the Corail hip implant approved quickly by giving inaccurate information regarding its design and use. The Corail system was approved under the FDA’s controversial 510(k) premarket approval system; an expedited process that requires that the medical device be functionally equivalent to a device already on the market in order to fast-track its approval. However, according to the warning letter, DePuy’s brochure on the device lists a number of claims about the device’s capabilities and specifications that were never approved by federal regulators.

The warning letter comes as Johnson & Johnson is under close scrutiny over quality control issues with its McNeil Healthcare pharmaceuticals subsidiary, which has had to issue two massive drug recalls this year and has suspended production.

On April 30, a recall was announced for nearly 40 liquid children’s medications made by McNeil Consumer Healthcare, including infant Tylenol, Benadryl, and Motrin. The products were recalled due to particulate contamination and irregularities in potency. As a result of the problems, the FDA issued a warning letter about quality control issues at the Johnson & Johnson manufacturing plant in Ft. Washington, Pennsylvania.

In addition, the company has issued a series of Johnson and Johnson drug recalls for a variety of drugs due to chemical contamination from wood pallets that give the drug a musty smell and have caused a number of people to fall ill. The problem is due to contamination by trace amounts of a chemical called 2,4,6-tribromoanisole, or TBA, which seeped into bottles from wood pallets treated with pesticide. The contaminated drugs had a moldy smell and made some users sick.

The DePuy unit itself has also faced a number of recent questions about the quality of the some other hip replacement systems. A DePuy ASR hip recall was issued earlier this year due to the high failure rate of the metal-on-metal hip implants.

In recent months, a number of DePuy hip lawsuits over faulty ASR Cup implants have been filed. It is expected that the number of cases will continue to grow as Depuy hip implant lawyers continue to investigate and review potential cases for individuals who have experienced problems and complications after hip replacement surgery involving the ASR cup.

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270 comments

  1. Kaitleigh Reply

    My mom had three jnee replacements (one obviously a revision) with the DePuy modular knee system and has done poorly ever since. Her docs say they cant explain her pain, swelling and general feeling of fatigue. She lives in TN, so the time for legal action has long since passed. We are just looking for a way for her to feel better. All the docs want to do is hand out more drugs for pain, for sleep, for swelling, for depression . . . And you know the drill. She is elderly and tired of advocating for herself. I live in another state and cant be present to give her a s much help as she needs to get better.

  2. Louise Reply

    My dearest friend had TKR with a DePuy Sigma Knee in 2007. He has swelling, pain, stiffness, warm to the touch, and SO MANY restless nights. Since 2007 he has had two additional surgeries. Earlier this spring/summer he underwent a total knee revision. It has not been easy. It really makes me sad to hear so many people are facing a very similiar situation. I think if more people reported their medical complaints to the FDA that would prompt the FDA to investigate consumer concerns more quickly. People who have been legitamately hurt by medical devices and drugs do have a voice. In my opinion if enough people let their voices and experiences be heard action make be taken. You can google search “fda medwatch” or click on the link below to the website. http://www.fda.gov/Safety/MedWatch/default.htm
    The instructions indicate that your privacy will be protected if you make the request. Spread the word and best of luck to everyone.

  3. Dale Reply

    I had the DePuy knee put in on 3-3-10. I worked hard to rehab and was doing okay, but kept getting infections. After about six months, I got real sore, and an infection set in, Now nearly three years later, I am still getting pus discharges and all of the doctors (and there have been many) say, ” looks fine, no problems”. Well, I can not walk much over 600 feet now, have lots of pain and keep getting pus/infections in the knee. I worked in QC, and find this totally unacceptable. These companies need to get more than a slap on the wrist. They are still pumping in money while we suffer over their wrongdoing.

  4. sheryl Reply

    I have two depuy hip replacements. The first one being the corail pinnacle hip implant.I haad this done in 08/2011. I had two dislocations in 8 months time. The first one only a month after the surgery and then the other a few months later. I just recently had my family physician check my blood for metal poisoning and the test came back toxic levels. He sent me to see my orthopeadic surgeon and he wants me to have an mri and I have no insurance. I feel like I should have been informed of the possible side effects of these implants and I feel like depuy should have to pay for my medical tests and care.

    Very unhappy patient,
    Sheryl

  5. Steve Reply

    Try having 6 total knee replacements on same knee in 6 yrs. last one got infected and did wash out 3 weeks later. Find out on January 15 if they are going to amputate. All depuy knees.
    Yes I think they have a problem.

  6. J.F. Bayless Reply

    I had left knee replacement in 2005. It has hurt from the beginning, but gets worse with each passing day. Knee locks up either in a straight position or in a bent position. Takes several minutes to get it to unlock. It is very painful. Also get horrible ‘charley horses’ in that knee at night.
    Painful to walk and if I have to walk very far, it is really painful. Doctor said it was in my head, so I changed doctors. New ortho doctor said there definitely was a problem. I want to know if there are any ‘class action suits’ regarding knee replacements with this product? If so, have there been any settlements and how does one get involved?

  7. Louise Reply

    Hello everybody it’s been a while….. Here’s whats been going on since my last post on Oct 7. My friend is healing fairly well from the TRK revision surgery in May 2012. He still has pain, but the pain with this new knee is way better compared to the other knee…..if that makes sense. I convinced him to start seeing a certified herbalist. This occurred after I started researching the benefits of herbs. So far so good. He does castor oil/an herbal oil??? packs for 30 minutes every night, in addition to his exercises and stretching. He is also taking an herbal tincture (40 drops twice a day). He is noticing small improvements in range of motion and pain level. The purpose of the castor oil packs is to break down the scar tissue as a result of three surgery on the same knee. The tincture is for immflimation. We are hopeful.

    @Bayless I don’t know of any lawsuits going on pertaining to the DePuy knee. We check the websites often. If you had a bad implant you should report it to the FDA…..see earlier post on October 14, 2012. Take care

  8. Joseph Reply

    On Feb 18 2008 ,I had DePuy Full Knee replacement.
    Its just over 5 years,and I still have swelling and pain.Biggest
    mistake i ever made.

  9. Bob Reply

    My story is the same, they look at an obviously f&*^ked up knee and say “It’s fine, perfect! Now go away.”. The ortho surgeons are complicit and the laws have to change. Lives are being destroyed 1 knee at a time while these c(*&k suyckerr rake in the huge fu*&king paychecks with virtually no recourse with the law, they get away with shoddy work, cheap crap products that could be sold off a walmart shelf. They are destroying people, might as well just just start killing people but instead theya re putting 10’s of thousands of people in suffering pain equal to a living hell. We have to stop them from getting away with this. Write your senators, write your congess, write your newspapers. This has got to stop!

  10. Louise Reply

    @Joseph and Bob, I really feel for you and all that your going through. Please please file your concerns with the FDA. It took only 10 compliants to the FDA for the them to do a knee recall….see link to story at the bottom of post. All the best.

    This post is a reminder of the importance of filing a complaint with the FDA if you have been injurged or had complications from a medical implant, regardless of the type or manufacturer. My October 14, 2012 post explains the process and provides the link to the FDA.

    Recently, FDA issued a Class I recall on the LPS Diaphyseal Sleeve used in the LPS knee system. Here is the link to the story listed on the FDA’s website.

    http://www.fda.gov/Safety/MedWatch/SafetyInfo

  11. Brian Reply

    I had a dupuy knee replacement in November 2010. I’ve been having problems since implant. I had three independent medical opinions and all indicated I need revision surgery because knee was loosening. I had severe swelling, pain and problems walking. I’ve had revision surgery on November 13, 2012. I’m still having problems. Knee continues to buckle, swell and cause severe pain. My knee was just fitted in a new knee brace on May 30, 2013. I’m back in physical therapy for knee again and I constantly tack pain medication just to walk.

  12. marjorie Reply

    I received a DePuy-PFC Sigma right knee replacement about 2 months ago. It’s healing fine, with no pain at all when I walk. But when I walk there is a “clicking” sensation (no sound) of the knee moving which is driving me crazy. It feels like something is shifting out of place. Nothing has “locked” it returns back to repeat with the next step.Has anyone else experienced this? Xrays are fine. Dr. said it will go away or in 1 year I’ll be used to it. Not the answer I was looking for. At this point I would rather walk incorrectly just to avoid this uncomfortable and creepy feeling. I’ve called the company and am waiting for a response. With others being in so much pain, sorry if this seems like a small complaint. I feel for all of you.

  13. Richard Reply

    I had recieved my Dupuy Sigma knee in July of 2012 and just finished my 12th month e-xray exam at the VA hospital in MPL. MN. and this is my second trip, i go at six months intervals, i am very happy with my full knee replacment and i have had no problums. I can bend my knee 115 degrees and i ride my bike almost every day weather permitting. I also have a stationary bike and i even climb trees. After reading some of the other comments this must be an unusal case. Ilive in Rochester, MN.

  14. cathy Reply

    I have had two tkr the first one was in dec 2009 and that one is doing ok just a little stiff. The second one was done in oct 2010 on the rt knee. I have had horrible pain after the surgery for 1 year then it got a little better but the past year it has bothered me even worse cant sleep at night for pain cant walk for long periods. So I called and made appointment with my Dr. that did the surgery and he did x-rays on both knees the lf is ok but the right is loose on the bottom.Waiting on workmans comp to approve treatment so I can get something done. It has been 5 weeks now and nothing yet. I will be contacting the FDA about this one also.

  15. Lorrie Reply

    I had a tkr done on June 23,13. Dupuy sigma implant. The pain was not bad until 3 months later & until my knee started crunching, clicking & making noises & causing me great pain. my doctor finally did some tests and discovered my knee was full of scar tissue. I went in on Jan 24,13 and had that all cleaned out & my knee felt good for 3 months & the pain started again. I went in for a MRI & now I have abnormal bone growth & the implant is loose in the femur bone. My Dr told me there was nothing more he could do & go to another Dr. Found one in a near by town and have a appointment the 1st of Oct. I had a partial in this knee in Dec 07\\\’. I am at witts end.

  16. Brenda Reply

    I had a left knee replacement on May 10th 2010. Dupuy knee. On May 10th 2011 my dr. went back in and did another replacement. Dupuy also. Did not help. Swelling never went away from the first one. Pain is unbearable. Knee also feels hot and painful to touch. The pain wakes me up continually all night long. My regular M.D. sent me to Mayo clinic. That dr. had no anwer and wasn’t in the room 10 min. I can’t walk for more than a couple of minutes. Can’t do stairs. I can’t stand to cook and cleaning my house is next to impossible. I am on pain medications to this day. I also have my own wheel chair and I have to use it or a public scooter if I go anywhere. I am 58 now and this has ruined my life. I just want the pain to go away and want my life back. I was a stay at home mom, and raised 3 kids, so I don’t qualify for disability. Just wish someone could help.

  17. Debra Reply

    I had a TKR in October, 2009 with a DePuy rotating platform. About 6 months ago, my knee started buckling out from under me with no warning and with intense pain, followed by an inability to put weight on the leg for a while. I finally saw my surgeon in Boston, and his response to my XRays was that he felt the cement was no longer adhering to the bone. He then sent me for blood work and a bone scan. Today I saw him for the results, and he essentially told me that there is no loosening of the device, according to the bone scan. I questioned his previous ominous interpretation of my X-rays two weeks ago, and his reply was that tests were inconclusive, including the very expensive bone scan. He said that he doesn’t listen to the tests, he listens to the patient. Basically, he threw the ball at me. If I am not happy with my device, he will be happy to replace it with something else! Personally, I know there is a big problem with the DePuy rotating platform, because I am in a lot of pain, and knee replacements should not be giving out on people or causing swelling and intense itching in the calf muscle of the operative knee either. Sometimes I just plain hurt all over the knee. A bone scan or X-ray cannot possibly diagnose flaws in the plastic or metal components. I read that symptoms of issues with this device include the giving out of the knee cap, which is what I think happens when I have one of my excruciating episodes. Are there others of you out there getting the same noncommittal response from your surgeons? I know everyone is paranoid about lawsuits, but this is my life here. I am too young at 57 to be living a limited life already. If the device is faulty, let’s own it and then fix it. I just want to be able to walk again without pain or instability.

  18. LaDonna Reply

    I had a DePuy Consensus Knee System for the right knee in Nov. of 2012.
    I only had knee pain when I walked. After the tkr I have pain 24/7.
    The original surgeon says there is no problem!. The revision specialist says I have lateral movement. I can’t have surgery again because of heart issues. The quality of life is horrible. I wish I had never had it done. I will choose the wheel chair before I have the left knee done.

  19. Bridgett Reply

    I had my first depuy knee replacement in January 2010 .When I got up to walk the 1st day I could not move my leg. So I go home in a lot of pain on oxycontin not taking away the pain taking them every 30min. Can stand for no one to even touch my leg ,leg go numb I fall on it two day out of surgery now pain is even worst want to cut leg off above knee ,go back to My Dr. He check leg say you got to go back to surgery, so I go and nothing they give me can take away the pain I am in crying all night asking nurses can place help me are call my Dr to up the dose on the morphine, he does pain don’t go away. So I go back to surgery and Dr remove skin tissues and send me to a nursing home for six weeks for intense therapy,while in nursing home they neglected me on the first day I’m there and my leg swells up 3x it’s sizes! So I get through that and get to go back home but still having a lot of pain.Continue to go to therapy and go back to see my Dr and he notice that I can’t straight my leg very far without being in a lot of awful awful PAIN so guess what on June 16 ,2010 I’m going back to surgery for the Fourth Time. And this was just my left knee three of the surgery were total knee replacements. Now tell me this washing a horror story but I really had to go through this ,and I have to have surgery on my right knee in November of 2014 (scare very scared)!!..

  20. perry Reply

    had a depuy knee replacement put in my left knee in april 2009,,,,constant pain,giving out.swelling….and fluid on my knee…can stand the pain..contacted depuy and they said nothing they could do about it

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