DePuy Knee Replacement Lawsuit Filed After Sigma Implant Failed, Resulting in Revision Surgery

  • Written by: Irvin Jackson

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An Arizona woman has filed a lawsuit against DePuy Orthopaedics and Johnson & Johnson, alleging that design problems with a DePuy Sigma knee caused her to suffer painful complications just months after she received the knee replacement. 

The complaint (PDF) was filed by Janet Smith in the U.S. District Court for the District of Arizona on January 8, raising claims for product liability, negligence, breach of warranty, and negligent and intentional infliction of emotional distress.

According to the lawsuit, Smith underwent total right knee arthroplasty on January 31, 2013, due to right-knee osteoarthritis, bone-on-bone grinding, and a deformity of the right knee.

A DePuy Sigma knee replacement system was used during her surgery, which was affixed using DePuy Cement. However, by May of the same year, she began complaining of extreme pain down her right knee, for which she was treated and observed until November 2013. At that point, the pain had continued, and she had developed a creaking sensation in her knee. Other problems, such as swelling, developed, until doctors determined that the DePuy Sigma had failed, and recommended she undergo revision surgery in November 2015.

“The prosthetic knee components used in Plaintiffs’ knee replacement surgery on January 31, 2013 failed to perform as designed, and such failure was caused by the defect of the product,” Smith’s lawsuit states. “Despite full knowledge of these defects and the knowledge that their failure to take any steps to fully advise physicians and patients would certainly cause injury to patients, the Defendants negligently took no action.”

Smith is seeking both punitive and compensatory damages.

The lawsuit comes as a growing number of knee replacement lawsuits are being pursued against DePuy and other manufacturers, raising similar allegations that design defects have caused high failure rates. In addition to the Sigma knee, reports of tibial failures have been reported by a number of individuals now pursuing potential DePuy Attune knee lawsuits, as well as complaints over the Exactech Optetrak Total Knee Replacement System, and the Arthrex iBalance knee system.

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  1. Jona Reply

    I have a sigma knee replacement and had 2 revisions. I continue to have pain, swelling ,clicking and grinding noises and now hip pain.

  2. Dan Reply

    I have a depuy sigma put in 2014 and it has been worse than the old worn out one. Pain, swelling, grinding, clicking. Have been told i must wear a brace to help with 50% of problems and try to avoid revision. I need the other knee replaced, but now i can’ t. It sucks!

  3. Hilda Reply

    I had the Depuy SIGMA MBT TIBIA component and it fractured twice on me I need someone to help me with this situation, I Suffered a lot of pain and suffering with this replacement can you please advise
    Thank You

  4. Lisa Reply

    My knee replacement is almost identical to Janet Smith’s where I underwent a total left knee arthroplasty due to left-knee osteoarthritis, bone-on-bone grinding, and the appearance of 2 potholes under my kneecap on 10-11-12 with a DePuy Sigma knee using DePuy cement. I have medical records showing how many times I saw the doctor because of pain. I even had a surgery on 6-27-14 for left knee patella clunk syndrome status post total knee arthroplasty.

  5. Tony Reply

    I’ve had 5 right-knee replacements all by DePuy in 4 years. It’s still not fixed and yet I can’t find an attorney to take on my case because they’re all interested in the DePuy Attune model! It’s ridiculous to go through what I’ve gone through but here I am…still searching for an attorney to represent me.

  6. Toni Reply

    Every one have problem with his knee replacement go to FDA website and report your knee name and part on knee replacement recalls and fill up all the form and tell them haw you feel a bout your knee and what doctor told you I’m on disability because my knee replacement go the fda website and report your knee replacement problem that’s only way we will found help from lower

  7. Osam Reply

    I have sigma knee replacement on my right knee I’m on disability after surgery my leg is longer up normal sound clacking when I wok to bathe any one can hear my knee pain all time staping when I go up stairs it’s nightmare knee replacement surgery I need Lowyer to help me doctor say I need anther knee replacement surgery but which one if all the knee part is bad surgery I’m reading the comments on hear all the knee surgery is bad

  8. Bernard Reply

    I had depuy sigma tkr in March 2015. Started hurting and actually bowed out in less than a year was told I need to replace part of the knee got 2nd opinion and choose tkr with a Zimmer NexGen LCCK in February of 2018 New knee is doing well.

  9. Lance Reply

    Original Sigma knee in 2010. 2nd ,top only replaced in 2013. Came loose the first time & within a short period of time the 2nd is also loose. Since both halves now have the extended peg, don’t think much of the remaining options.. Extreme pain

  10. william Reply

    I had both of my knees done in 2009.I have had nothing but pain since with repeated visits to the doctor . all that was done was pain pills therpy and scoped both knees.I,m in a lot of pain and need help.

  11. marla Reply

    i hag a sigma put in 3 months ago i still wake up with pain every 2 hours i have done everything dr. said to do had a closed manipulation 3 weeks ago gone to very painful physical therapy where they pushed down on the knee as hard as possible grabbed my ankle and shoved it to my butt all resulting in tears streaming down my face i even went and bought a recombant bike. i was told no pain no gain and you can’t damage the implant. i am in much greater pain than before the implant and have very little range of motion.

  12. Irvin Reply

    I had a Depuy Sigma total knee replacement in November 2013. I had a difficult time in the beginning for about a year. It got better but the pain kept coming back. The Dr. Tried so many things to relieve my pain but it still persisted. My knee would give way many times & I had many falls. Therapy was a painful temporary fix just to find out it had came loose & there was a painful play in my knee. It sounded like rocks being rubbed together. I finally got a revision August 2018 with the same type of Sigma knee. It is painful but I hope it’s because it’s too new to tell. I need direction because I feel just like Janet Smith. I expected more & greater from this knee replacement. It’s just as painful as the bone on bone, I feel I made the wrong choice getting this done.

  13. Donna Reply

    If sigma is under recall why are no attorneys touching it . Also the cement that was used in mine is under recall as well. I have had 4 left knee. THIS IS RIDICULOUS!!!!

  14. Linda Reply

    I had left knee replacement in June, 2010. I have had pain and swelling, clicking and giving way of the knee from the beginning. It was a Sigma by Depuy. I have talked to several doctor’s over the years,but was always told “Oh it’s ok. It will be alright. I finally had a doctor tell me that I needed my right knee replaced also. I said until someone can do something to fix the left kneee I will NEVER have surgery on the right. He replied Well just say when, I can fix it. So I had revision surgery January 21, 2019. Turns out the Sigma replacement was one and one half to two sizes to big. Doesn’t sound to me as though the parts were bad. sounds as though someone’s judgement was bad to me. So why can’t I find anyone to help me with this problem? I have had a lot of severe pain and missed out on a lot of life overt he past 8 .years because of this.

  15. Randall Reply

    I had my right knee replaced using Sigma by Depuy in 1/2017. The pain, clicking, swelling and knee giving out has increased with every passing day. My surgeon says the parts are shifting and the cement has let go. I am now at the point having had to use my left leg to put my weight on, that that left knee is bone on bone and needs replacing as well. In fact the left knee is worse than the right knee was before the replacement. I don’t want to have the same parts put into my left leg that mal-functioned on my right. I have been searching for an Attorney to take my case, however none will do Sigma by Depuy.

  16. Vivian Reply

    I had my sigma done in 2007, then in 2011 it started giving me pain. I went back to my doctor and he wrote a prescription for pain. I did NOT take it. Then in 2015 my left knee gave way and I injured my right knee when I fell. Went back to the doctor and he said that everything was fine….obviously he is NOT using MY knees. I asked for my records and was told they have been destroyed….I guess that is one way out of responsibility. So I guess I am just out of luck…..who will take a case like this so I can get some funds to pay for more surgery IF I CAN FIND SOMEONE I CAN TRUST??????

  17. Carmen Reply

    Is it true that the lawyers are not working on the sigma knee replacement? I had mine replaced in 2012, nothing but problems. My kneecap went loose and had to have a revision surgery.

  18. Monica Reply

    3 replacements and still no relief!!! Depuy sigma….on disability…6 uears of non stop pain!!!! I need a lawyer to help…

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