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Hip and Knee Implant Failure: FDA Sends Warning Letters

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Rockville, MD: If you have recently had hip or knee implant surgery but are not feeling as well as you should, you are not alone. In fact, many people may be suffering the same pain you are—and the company that manufactured your replacement hip component parts may have caused that pain.

Knee SurgeryThe FDA is now concerned enough that it has sent warning letters to the president of Stryker Biotech, warning that the company's practices, "…are not in conformity with the Current Good Manufacturing Practice requirements of the Quality System regulation." At least three warning letters have been sent to the company regarding the issue. The FDA says that deficiencies at Stryker's New Jersey manufacturing facility resulted in the manufacture of defective hip replacement components, causing injury to patients who received the defective components. Some of the patients who received defective parts required further surgery to replace those parts.

According to one letter from the FDA, sent on November 28, 2007, Stryker received "continual complaints" starting in January 2005, regarding hip implant components that had poor fixation, made squeaking noises and were improperly seated, resulting in bone fractures. Further complaints included patients experiencing pieces of implant parts breaking off, difficulty walking and pain. The FDA goes on to note that Stryker has not yet taken adequate action to correct the problems.

During a six-week inspection of Stryker's New Jersey plant, the FDA found numerous issues, including instances of Staphylococcus bacteria, the pathogen that causes staph infections. The FDA's letter notes that Stryker, "has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence."

What this means for patients who received hip implants by Stryker is that they may have received faulty parts. It may also mean that they require additional surgeries to correct any implant defects they have been exposed to.

Hip and knee surgery can be very painful, requiring a long recovery time. Patients who have already undergone hip or knee surgery should not have to go through the excruciating process again, especially not if the problem has been caused by failure of the device-maker to design a safe product. Unfortunately, some patients who have received defective implant parts now face the daunting task of having further surgeries.

Along with the addition surgeries come additional medical bills, additional time off work, and additional recovery time, not to mention the additional time spent in pain and struggling to walk. All that can add up to one big headache for patients who were given defective hip or knee implants.

If you were implanted with defective hip or knee parts you may be eligible to join a lawsuit against the manufacturer of the defective parts. Contacting a lawyer to discuss your options would be a good idea.

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READER COMMENTS

Posted by
Jerry Zigmund
on
Had double knee replacement 9-9-05. Since the weekend was here, they moved my pain block in the wrong place and the pain was intense, leading to thoughts suicide. Hoped by having both done at the same time, it would halt another hospital trek. Right now, am worried about poisoning, which I never heard of before. Am restricted from walking any distance and am using canes, walkers and hopefully a scooter upcoming. Am also wondering that I have been diagnosed with restless leg syndrome...could this knee problem be the cause...and not RLS???

Posted by
Beverley
on
I had tkr in Dec. 2009 w/Stryker Triathlon and it hurts worse now than before operation. It proceeds to get worse every day. I am in process w/new doctor to determine what the problem might be. Told by doctor who did initial operation there were noted problems w/Triathlon and he could put a spacer in. I want to know who is going to pay for that? Stryker claims they know nothing about any noted problems. Just had bone scan today will see new doctor again next week to go over his thoughts.

Posted by
Phyllis
on
I had total knee replacement on 2/29/12. My surgeon uses the Stryker Triathalon Knee. I have had NO problems with my new knee. It does get a tad stiff during the day due to my sitdown office job. I have to keep reminding myself that I have to keep up with the exercises I learned after surgery. I do NOT take any pain meds at all! I am planning on doing my other knee in March 2013, using the same surgeon and Stryker.

Posted by
B.T.
on
I had a knee replacement in May of 2012, they had to another in Oct 2012. My knee still not right. On pain pills every since May, had a manipulation two week ago to bend and straighten the leg, still in pain and cannot walk independently on it. I was told two weeks ago, I will have problems for the next year. Now looking for some kind of help.

Posted by
S ws
on
Both of my Stryker knees have failed.they move side to side give put and cause me extreme pain I had a triathalon to

Posted by
TWB
on
I had a TKR on my right knee in Nov 2011 and have had problems ever since. It hurts constantly, pops, swells, squeaks and feels like a tight band is around it. Walking, standing and sitting increase the pain and other problems. I have a stryker triathlon knee and was wondering if anyone else has had this problem, and if there is a recall on this knee.

Posted by
J B
on
I had both knees implanted with Stryker Howmedica Triathlon total knees in 2006, by 2010 my right knee was failing and the doctor said it was unstable. I now have to use braces on both knees and always use a cane, the instability is getting to the point of needing a walker soon. The continual pain is very difficult to deal with. My medical issues are such that the surgeon is loathe to preform a revision. I have notified Stryker and have sent them all the information regarding the initial surgery and the numbers of the parts implanted, and am waiting to hear from them. I have been unable to find a lawyer to take my case, to date I have contacted four law firms and have not found anyone wanting to deal with this matter. I hope that a class action will start in Canada. The FDA has information regarding failed implants with the same numbers as the ones in my knees, and it seems that the implants produced in Limerick Ireland are the ones that are failing. If anyone reads this and can help me and others with this problems, PLEASE do so.

Posted by
J G
on
I had a knee replacement on 10/04/10. It hurts all the time. I sleep with a brace from my groin almost to my ankle. It keeps my knee straight. I can't have a good night sleep. I can't bend the knee. Therapy helps some. After a walking a few blocks I start dragging my leg. It is worst when I sit. The doctor said that it will take six months to a year to heal. I'm still taking pain pills. It is a nightmare.

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