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Zimmer NexGen CR-Flex KNEE REPLACEMENT

Were you looking for Hip & Knee Replacement lawsuits?

Since the Zimmer NexGen knee replacement system has been on the market, almost half a million people in the US alone have had Zimmer knee implants. However, the Zimmer knee replacement, namely the NexGen CR-Flex Porous Femoral component, has recently been linked to a variety of problems, from loosening of the implant to failure of the replacement knee, requiring revision surgery. As a result, some medical professionals have called for a Zimmer NexGen CR-Flex recall of this component, though that has not yet happened. Zimmer NexGen lawsuits are now being reviewed by Zimmer knee attorneys for people who have experienced problems with the Zimmer NexGen CR-Flex Porous Femoral component. Some patients have also experienced problems with the Zimmer Durom Cup hip replacement.



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Zimmer NexGen CR-Flex Porous Femoral Component

hipkneereplacement Zimmer NexGen Knee was approved by the FDA in 1994, and since that time more than three million NexGen knees have been implanted worldwide. But data now indicates that certain Zimmer knees--namely the NexGen CR-Flex Porous Femoral component--have been associated with unexplained pain after knee replacement, loosening of the implant and failure of the replacement knee leading to revision surgery.

Zimmer NexGen CR-Flex Porous Femoral knee component failure rates are high--according to a study published in the American Academy of Orthopedic Surgeons. This study was also noted in Zimmer's SEC Form 8-k filing, Exhibit 99.1 (3/11/10), with Zimmer's response:

"Zimmer's NexGen ® CR-Flex Porous Femoral component was the subject of a study of 108 patients ("The High Failure Rate of a High-Flex Total Knee Arthroplasty Design") by Drs. Berger and Della Valle of Rush University Medical Center. According to the published abstract, Drs. Berger and Della Valle revised 9 (8.3%) patients for femoral loosening and pain. The study also reported that 39 (36%) patients showed evidence of radiographic loosening and that "[l]oosening and revision were not related to surgeon, approach or patient type."

"The NexGen CR-Flex Porous component has a strong track record of clinical success. According to the 2009 Australian National Joint Replacement Registry report, Zimmer's NexGen cementless total knee arthroplasty (TKA) components recorded the lowest revision rate (reported as revisions per 100 observed component years) of all major cementless TKA systems utilized in the market (0.5 revisions per 100 observed component years). Of the 7,100 implantations using the NexGen CR Porous or NexGen CR-Flex Porous systems since 2004, revisions were reported for 120 patients, representing a revision rate of 1.7%, inclusive of all components and reasons for revision.

"The performance of the NexGen CR-Flex Porous Femoral component in the Australian National Joint Registry and in Zimmer's post-market surveillance activities demonstrates that it is a safe and effective product when used as indicated in the surgical technique. More than 150,000 NexGen CR and NexGen CR-Flex Porous Femoral components have been sold since 2003. Sales of the NexGen CR-Flex Porous component represented approximately 2% of the company's knee revenues in 2009."

The design of the NexGen CR-Flex knee has a high-flex porous femoral component that attaches to the bottom of the thighbone instead of using cement to keep the knee replacements in place. Some orthopedic surgeons believe this design to be defective and unreasonably dangerous, and can potentially expose patients to an unnecessary risk of problems.
 

Bone Scan to Diagnose Knee Replacement Problems

If you are experiencing pain from your Zimmer NexGen knee replacement, ask your doctor for a bone scan. To preserve your potential Zimmer claim, attorneys recommend this diagnostic test (rather than a general x-ray) to confirm that your replacement knee is loose. A bone scan will be able to identify 'remodelling'—when the device is loose, surrounding bone tries to form new bone.

A bone scan involves injecting a harmless amount of radioactive material (radiotracer) into a vein, which travels through the bloodstream to the bones and organs. As the substance wears away, it gives off radiation. Then this radiation is detected by a camera that takes an image of the bone surrounding the artificial knee. Usually the scan will take about one hour.
 

Zimmer NexGen Timeline

zimmerkneedoctor2002: Zimmer announced " Positive Results of Minimally Invasive Total Hip Replacement Study and Plans for a Dedicated Surgeon Training Institute". Dr Richard Berger, M.D, a consultant for Zimmer, was then pioneering a type of small-incision surgery that allowed patients to leave the hospital on the day of surgery and he was prominently featured in a press release about Zimmer's plans to build the training facility.

2005: Dr Berger had implanted the NexGen CR-Flex device—which is supposed to last about 15 years—to about 125 patients.

Early 2006: Some X-rays from patients who had received the device in 2005 showed lines where the implant met the thigh bone, an indication that the device was loose and had not fused completely.

2007: Dr. Berger, although still a Zimmer consultant, had stopped using the NexGen knee replacement and said that several other surgeons had also experienced problems with it.

March 2010: The failure rate data (above) was presented by a group of knee surgeons at a conference of the American Academy of Orthopedic Surgeons.

June 2010: The New York Times reported disputes between Zimmer and two of its top consultants. One of the disputes involved the NexGen CR-Flex knee component. The consultants claimed the components were defective and failed soon after they were implanted, but Zimmer officials blamed the surgeons' techniques for the failure.

One of the consultants was Dr. Berger. Over the past decade, he had received more than $8 million from Zimmer for his services and in 2005 he implanted Zimmer's NexGen CR-Flex device in about 125 patients, according to the NYT.

Berger noticed that some X-rays showed lines where the implant met the thigh bone, which indicated that the device had not fused completely. Although patients were able to walk, they experienced severe pain. Berger also found Zimmer's knee showed signs of loosening in about half of all patients and many needed to be replaced. Berger reported his findings to Zimmer.

Another consultant, Lawrence Dorr, M.D, had reported problems to Zimmer regarding its Durom cup hip component. Although the cup failed within a few years of being implanted, Zimmer claimed the problem was with Dorr's technique and not because the device was defective. (Durom cup lawsuits are pending.)

July 2010: Senator Charles Grassley (R-Iowa) issued a letter to Zimmer Holdings, which focused on the pharmaceutical company's transparency regarding its disclosure of payments to healthcare professionals. In the letter, Grassley refers to the June, 2010 article in The New York Times:

"I was troubled by last month's New York Times account of Zimmer's response to the allegations of safety concerns raised by two of its consultants. Specifically, The New York Times reported that one of the surgeons with whom Zimmer had a financial relationship, Dr. Richard Berger, raised concerns to the company a few years ago about the premature failure of a Zimmer knee, the NexGen CR-Flex.1 According to the article, Dr. Berger was a long-time consultant for Zimmer--a financial relationship that spanned more a decade--with Dr. Berger receiving more than $8 million during that time frame. The New York Times also reported that a second Zimmer consultant, Dr. Lawrence Dorr, alerted other doctors that Zimmer's Durom hip device was failing a few years after they were implanted in patients. According to The New York Times, the two doctors were not alone in their concerns about the device failures. In both cases, however, Zimmer responded that it was the surgeons' technique, not the devices that were flawed."

The letter asks Zimmer officials to disclose the way they track the long-term performance of orthopedic devices--their product assurance and complaint handling systems. Zimmer reportedly met with members of Senator Grassley's Committee staff and received notice of satisfactorily responding to the requests.

December 2010: While there has not been a recall of the Zimmer NexGen CR-Flex system or components, on December 2, 2010, the certain lots of the Zimmer NexGen LPS Flex Gender were recalled. The recall included the following Zimmer NexGen Complete Knee Solution LPS Components:
 
  • Zimmer NexGen LPS Femoral Component, Size E Right, sterile, REF 00-5996-015-02
  • Zimmer NexGen LPS Femoral Component, Size F Right, sterile, REF 00-5996-016-02
  • Zimmer NexGen LPS Femoral Component, Size F Left, sterile, REF 00-5996-016-01
  • Zimmer NexGen LPS Femoral Component, Size G Right, sterile, REF 00-5996-017-02
  • Zimmer NexGen LPS Femoral Component, Size G Left, sterile, REF 00-5996-017-01
  • Zimmer NexGen LPS Flex Gender Femoral Component, Size E Right, sterile, REF 00-5764-015-52
  • Zimmer NexGen LPS Flex Gender Femoral Component, Size E Left, sterile, REF 00-5764-015-51
  • Zimmer NexGen LPS Flex Gender Femoral Component, Size F Right, sterile, REF 00-5764-016-52
  • Zimmer NexGen LPS Flex Gender Femoral Component, Size G Left, sterile, REF 00-5764-017-51

    The NexGen LPS knee replacement components involved in the recall were due to these components having a nonconforming internal CAM radius (nonconforming geometry). According to the recall notice, surgeons were notified, but no action was to be taken by surgeons.
     

    Zimmer NexGen Knee Replacement Legal Help

    If you or a loved one has suffered damages in this case, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.

 


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ZIMMER NEXGEN LEGAL ARTICLES AND INTERVIEWS

Tentative Settlement Reached in Zimmer NexGen Knee-Implant MDL
Tentative Settlement Reached in Zimmer NexGen Knee-Implant MDL
February 15, 2018
Los Angeles, CA: Zimmer, the maker of NexGen knee replacements and the defendant in a defective products multi-district litigation (MDL) has reached a preliminary settlement with the plaintiffs in the longstanding MDL. READ MORE

Better Off before Zimmer NexGen Knee
Better Off before Zimmer NexGen Knee
November 25, 2014
Albert’s mother had a Zimmer NexGen knee replacement six years ago and she has been suffering with Zimmer knee replacement problems ever since. “Mom said she was better off before having this NexGen knee,” says Albert. READ MORE

Zimmer NexGen Knee Patient Wanted Her Leg Amputated
Zimmer NexGen Knee Patient Wanted Her Leg Amputated
October 26, 2014

Huntsville, AL: Pam had a Zimmer NexGen knee replacement two years ago, and she has been suffering ever since.

“I told my surgeon that I wished he had just amputated my leg,” Pam says.
READ MORE

READER COMMENTS

Posted by

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I had my Zimmer knee replacement in 2011. I was off work for 6 months. Within a month of going back to work I was having a lot of pain in it. I went to the dr. and he said they had to wait for a year before they could do the bone scan to see if it had come loose or not. I suffered thru 6 months until I could get the scan done. Of course it came back showing that it had come loose. I had to have a revision done and after another 6 months of being off work my doctor told me I should not go back to work doing what I did. I had done this work all of my life and had no other skills. It was bad enough I was able to go on disability but it was for a lot less than I was making, I was not ready for it financially and now am barely making it and not sure what kind of a future I have. I did sign on with a lawyer but after 2 and a 1/2 years they came back and said the courts had ruled on some things and they didn't feel like I would qualify. They said it didn't show where I had flexion of 120 degrees which I know I did and it was in my records. After all of the pain I went thru it is really a shame that big companies that have tons of money can get away with ruining a person's life. I had the surgery so I could continue to work.

Posted by

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I had Zimmer total knee replacements in 2007 in which both malfunctioned by loosening within 3 years, although, my Doctor told me these were a new product of Zimmer that "should last a lifetime". I was 57 yrs. old at the time of surgery. I had revision surgery of both knees in 2011. In 2016, I was having severe pain and had my 5th total knee replacement. No one should have to endure so much excruciating pain!

Posted by

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I had the first left knee done in 2008. It was great for about two years. Then I started to have problems. Went back to DR who put it in and said there is nothing wrong. I could just about walk. I love to hunt but that is all over now. Went to another Dr and from the first visit he told me my knee was loose and he had to replace it. This was 2011. Since then I have pain all the time. Dr who put the second knee in said there is nothing wrong. Finally out of desperation I went to another DR and he told me that I have a nerve pinched in my leg and that is what is causing so much pain. He said to look for it is like looking in a hay stack for a needle. No more hunting and I can't walk far. I wish they could cut it off but I remember what my dad went thru when he had his leg cut off.

Posted by

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I had a Zimmer total knee replacement in April of 2012. some of the notes from surgery do not state that it was a Zimmer product but the Doctor told me it was. I had this done at a V.A. hospital. I still have a numbness and some pain in the lower front and at times a clicking when in motion. How do I know what Zimmer product was used ?

Posted by

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I had a total left knee replacement in 2008. In 2010 I started having bad knee pain and I couldn’t walk without seeming like I was going to fall.

I met with my surgeon and his response was I need more PT which I did. After going back to the surgeon a couples times with the same complaint and not getting any good response, I chose to get a second opinion. My second opinion surgeon identified the device had become loose and was just flopping around.

The only thing to do was to remove the device and put in a different one. So I chose this route and a revision was done in 2011. Because of the damage from the original device the surgeon didn’t have much to work with once he got inside the knee. He explained prior to the surgery that this might be the case. So he had to do a few other things to make sure this device would stay in place.

I did all the PT that’s required but my range of motion was never back to normal, I walk with a limp, and I am now if chronic pain 24/7 due to a nerve being compromised during the revision surgery ( I don’t fault the surgeon because this is one of the risks that can happen with this type of surgery.)

My quality of life has gone out the window all because of the original device loosening. I cannot walk very far because it’s too painful being on my feet. I use a power wheelchair and cannot be away from home for very long because my leg requires elevation most of the time.

Posted by

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Pain and infection sine the day my Zimmer knee was put in. Just went through knee revision and knee replant. Original knee implant 5/2013. Revision 12/2014. Replacement knee 2/2015.

Posted by

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I have a problem knee, recalled in 2010. It was put in in 2012. I have lost everything - job, family, lifestyle because of it. I may not be able to have a revision as the surgeon has said it's doubtful it will resolve my problem. I have talked to attorneys who are only interested if I have the revision surgery. Why would I trust them to go back in and have another hack at me?

Posted by

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I am still trying to get relief from total implant on right knee since 2010 & 2011 difficultly walking standing and sitting more pain than before surgey. I had to retire from my job early cannot stand for long periods of time. Are ther any answers . Is there any help?

Posted by

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Pain, loosening. I had revision surgery because the first knee surgery failed and the Zimmer knee piece started to hyperextend so they had to create a special piece to fix it and it still isn’t working right!

Posted by

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Since my knee replacement in Nov. 2009, it feels like I have nails, nuts, bolts and pliers inside my knee. My knee is swollen and I now have additional protruding veins from my feet all the way up to my surgical knee. Know the left side of my hip and back are aching constantly as a result. Instead of getting better, my knee symptoms have gotten progressively worse.

Posted by

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Had total knee replacement in NC on 11/9/11. Knee never felt right. Moved 5 months later to SC. Finally went to new surgeon - had tests run including bone scan, and determined that knee never attached on both top and bottom - new total revision surgery with different company scheduled 12/17/13.

Posted by

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I received a Total left knee replacement on 31 Jan 2012. In April 2013 I started experiencing severe pain and unsteadiness in my left knee. After consulting my doctors I went through a series of X-rays and a nuclear medicine bone scan. My Orthopedic surgeon has told me the prosthesis has come loose from the bone at the tibia and at the femur and that I will need complete knee revision surgery.
Please contact me and let me know if this is from a defective knee.
It is the Zimmer CR-Flex

Posted by

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Constant pain, Right knee pops when I walk. New knee is still swollen and painful. Left knee is painful.

Posted by

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I cant walk without limping - have five blood clots - fatigued from dragging leg around - HATE it - wish I had never had this done.

Posted by

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I had this knee replacement oct. 19, 2010. I have had nothing but severe pain and cramps in that knee and my leg. Saw dr. in Houston, had bone scan, the cement is cracking and coming apart. The pain continues.

Posted by

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I am only 50 years old and I am limited to what I am able to do. I cannot squat or kneel down which causes my back pain to be constant. I have had numerous x-rays, bone scans and am told that the device is fine. My doctors office wants me to come in again to have it looked at because I requested the name of the prosthetic they used. Whenever I go to the doctors office I am told there is nothing they can do that this happens sometimes and suggest physical therapy which only makes my pain worse. For over a year now I have had terrible hip pain as well.

Posted by

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Confined to a wheelchair. Pain, swelling, heat. Not able to do the things I enjoy - camping, gardening, keeping my house clean. Depression, anxiety.

Posted by

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pain and suffering. lack of sleep. can't work. anxiety. affecting my marriage.

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