Zimmer recalls over 40,000 NexGen Total Knee Replacements |

Zimmer recalls over 40,000 NexGen Total Knee Replacements

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OVER 40,000 ZIMMER NEXGEN KNEE TIBIAL COMPONENTS RECALLED (Orthopedics This Week)

Zimmer Holdings, Inc. is recalling 41,180 stemmed tibial components of the NexGen Complete Knee Solution system.

According to an FDA Enforcement Report for the week of July 9, 2014, the company is initiating a voluntary recall of specific identified lots “due to the potential that the threads may be out of specification.” The recall is of various sizes and part of the “NexGen systems of semi-constraint, non-linked condylar knee prosthesis.”

The lots can be found here.

Recall Initiated May 19

The recall was initiated May 19, 2014 with a letter to relevant parties. The recall is considered a Class 2 recall, indicating the damaged device might cause temporary or serious medical complications. Zimmer sent out an urgent medical device recall letter to medical professionals on June 10. The components are manufactured by Zimmer Manufacturing B.V. in Puerto Rico.

In its letter to medical professionals, Zimmer reportedly said some of the tibial baseplates were made with defective threads in a hole where surgeons screw in a drop-down stem extension or stem plug. If not threaded correctly, the device could loosen and fail.

Complications

Zimmer said the problematic device could lead to one or more post-surgery complications:

  • Infection: The patient runs the risk of serious infection if the surgery is delayed or if a secondary implant is not immediately available and the surgeon must close the patient and return later.
  • Bone Loss: The patient may have additional bone loss if the tibial device is cemented in place and the surgeon must remove and replace it.
  • Early Revision Surgery: If the device loosens or infection occurs, this could lead to revision surgery.
  • Dislocation: If the stem is not properly placed, the devices may not adequately lock. This could lead to a dislocation.

According to drugwatch.com, the device is commonly used with other Zimmer knee replacement systems like the LPS-Flex and CR-Flex minimally invasive knee replacement devices. Surgeons install the tibial component during minimally invasive knee surgery, which has shorter recovery times, less blood loss and a greater range of motion because of tissue-sparing techniques. They assemble the component once the new knee is put in place. That tends to make the faulty pieces more problematic.

Complaints and Lawsuits

Within months of the company’s urgent device correction letter, drugwatch reports that the FDA received 114 complaints of early loosening and found that the company provided improper instructions and warnings about the device to surgeons. The FDA issued a Class 2 recall, affecting 68,383 devices that had already been implanted.

Shortly after the FDA issued its recall, injured patients started filing lawsuits. A multidistrict litigation (MDL) was opened in the U.S. District Court of Illinois under the oversight of Judge Rebecca Pallmeyer.

Today, there are more than 1,000 lawsuits. In an order issued in March 2014, Judge Pallmeyer identified six Zimmer NexGen bellwether trials (each side selected three cases) and scheduled the first bellwether cases for trial in February 2015.

12 responses to Zimmer recalls over 40,000 NexGen Total Knee Replacements

  1. Ajay Anand July 30th, 2014 at 11:47 am

    Not much to tell right now

        Reply

  2. Ajay Anand July 30th, 2014 at 11:48 am

    Hi

        Reply

  3. Leonard September 23rd, 2014 at 11:44 am

    Hi I had my zimmer Nex-gen total knee replacement System put in on 06-09-2008 I’m trying to get the info from the hosp to see if it was one that was recalled. I have seen Zimmer a email and they told me what to do. They are trying to get me to send them some info and X-rays but I told them I would hold off doing that. If need I will talk to a lawyer first. I have not heard back from them after that. Will let you all know what I find and we see where I some go from there.

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  4. Sara Johnson November 6th, 2014 at 8:30 pm

    June 17, 2014, I had TKA right knee with zimmer nex gen LPS flez GSF femoral component size E right ref 00-5764-015-52.
    I am in constant pain, difficult to walk/ bear weight. swollen stiff knee, loose feeling, clunky popping noises.
    am I a candidate for the zimmer knee lawsuit?
    sara Johnson
    dob 4/4/1937

        Reply

  5. Martha Sisco July 27th, 2016 at 12:29 pm

    I had a zimmer Nexgen Lps-flex TKR in October 2014.I have chronic pain, lack of extension,a feeling of my knee giving out. Also 4 days post-op I developed bacteremia, I spent an extra week in the hospital,the day I developed the infection I was discharged to a rehab. I realized something was wrong once I had been there for a couple of hours, and had to demand that I needed to go back to the hospital. I take dilaudid for the pain,but with little relief. I need to find an attorney,which is turning out to be a difficult process.

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  6. Gale A Virgil October 4th, 2017 at 10:39 pm

    I just heard about a recall. I had my surgery in 2012 and have been in pain ever since. I have even had a shot in my knee last year for the pain and fluid withdrawn. I can tap on my knee and it sounds like someone knocking on a door. Even when walking, the knocking can be heard. I have to take pain pills to ease the pain. I have gone back several times and the dr. does exrays and say the implant is still in place. I feel like something has come lose.

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  7. Butch April 16th, 2018 at 7:33 pm

    I had a Zimner put in in 12/20/12 and had severe pain from the beginning. It took me over two years to get my doctor to look at it (statue of limitation is two years) and he found the knee loose and infected. Recall on Zimmer was 2014 and I was never notified. The was removed and antibiotic implants put in and straight leg brace for next six months and on crutches. Lost all trust in doctor because of all the lies he told us and found new doctor that put in a new knee. I am still in severe pain, infection still in knee and living on pain meds.

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  8. Bessie ream April 26th, 2018 at 3:43 pm

    I have same problem except my knee did give out and I fell and broke my arm trying to catch my self I had mine done one year ago may 25 2017 and dr takes Ezra us and says everything is fine even if I can’t hardly walk or take a step down or up stairs now I’m being told I have to much weight and that’s what’s causing the problem

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  9. Sandy July 12th, 2018 at 12:35 pm

    My Eius knee came loose in under a year caused metallosis of course stryker will not compensate me for it
    The PKR also failed
    My total knee replacement Stryker triathlon with conformis with mako shape match cutting guides failed
    Now I live a life on pain pills
    Stryker of course used Dr Valadie a paid consultant to defend Dr Levitt another stock owner and paid consultant I lost my case Witt vs Stryker
    The subpoena for Jack Jieafa part owner arthrex for failing to fill out adverse event reports was given a bonus by Mr Mason wow no justice for patients just pain

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  10. Miriam Dorn September 8th, 2018 at 1:35 pm

    I had my replacement in January 2015 and I can hardly walk sometimes. It is definitely separated below knee and keeps getting worse. A second opinion said it was failing. I need s lawsuit b cause I cannot work and need it redone

        Reply

  11. Vickie kurtz October 23rd, 2018 at 7:13 pm

    I had a total nee replacement of the right in2014 and 2013 my nee hurts was now then befor the surgery and it pops and grinds a lot it even trys to bend the wrong way it bends backwards and I lose my balance can anyone help me

        Reply

  12. Tony gibbs November 7th, 2018 at 5:18 pm

    I had a thks done in 10/2008 and a revision done in 4/2010.what can I do at this point

        Reply

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