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Smith & Nephew Hip Manufacturing Problems Result in FDA Warning

  • Written by: Staff Writers
  • 58 Comments

Federal investigators have issued a warning to Smith & Nephew PLC about quality control problems that need to be corrected at a plant that manufactures hip replacement implants. 

The FDA sent a warning letter to the U.K. company on December 21, calling for corrective actions at its Tuttlingen, Germany, production facility. The plant is responsible for the manufacturing of the R3 Ceramic Acetabular System, but the FDA says that its processes to validate and verify the quality of its products lack in a number of areas.

The letter stems from FDA inspections of the plant that occurred in July. The company initially sent a response to the FDA addressing its concerns, but the response was deemed insufficient, according to the warning letter.

Among the problems that the inspectors found was a failure to confirm the validity of the plant’s minimum and maximum settings for a titanium ring press. Inspectors also said that the plant failed to verify that corrective actions taken to fix a problem where radiation-sterilized parts were not getting enough radiation were actually working. When the problem recurred later, the plant blamed it on employees not following the new procedures.

The FDA inspectors said that attempts by the plant to address the problems had failed because there were no procedures to make sure that the fixes were actually working. As a result, a number of problems that the plant had supposedly addressed cropped up again.

The company has 15 days to respond to the letter. If it fails to respond or adequately address the FDA’s concerns, its parts could be seized when they try to ship them to the U.S. without warning.

In 2007, Smith & Nephew agreed to pay $28.9 million to the U.S. Department of Justice over kickbacks it paid U.S. doctors to implant their hip and knee devices into patients. As a result, the company underwent 18 months of federal monitoring.

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Image via: Art Konovalov / Shutterstock.com

58 comments

  1. Matt Reply

    My smith nephew resurfacing from 2009 failed due to impingement. Talk about painful. I got sent back and forth between back doctors and hip doctor. I even had my Di joint fused because they said it wasn’t the hip.. I really hope there is something for compensation but I have a feeling I’m just screwed.

  2. DAN Reply

    I HAD A SMITH AND NEPHEW IN 2007 WITHIN 6 MONTHS I WAS HAVING GROIN PAIN AND HIP PAIN IT WASENT TILL 2009 WHEN MY LEFT HIP WAS DONE BY A DIFFERNT DOCTOR I WAS TOLD RIGHT AFTER SURGERY I WAS TOLD BY DOCTOR MY RIGHT HIP CUP WAS TO SMALL AND THAT WAS THE CAUSE OF PAIN I KNOW THERE WAS A PROBLEM WITH MISLABELING PARTS HAS ANYONE ELSE HAVE THIS PROBLEM STILL IN PAIN EVEN AFTER CUP REPLACMENT BY BE IT DUE TO THE DOCTOR DRILLING THROUHG BY ANTERIOR COLUMN WITH A SCREW NOW 3/4 INTO MY ILIOPASA MUSCLE NOW NO DOCTOR WANTS TO FIX THIS MESS IAM ONLY 50 IN GOOD SHAPE GREAT WEIGHT IAM JUST COFUSSED AND I REAL BAD PAIN

  3. DANNY Reply

    my first hip replacement was 2007 where a smith and nephew implant was used within 6 months I was having problems squeaking sounds and groin pain I was told by doctor it was not my hip but I heard all kinds of excuses went to a new doc how replaced my left hip which also had to be done he said it might help my right but right after surgery he told me that the smith and nephew cup was to small so he revised it but at the same time caused more problems by drilling a screw through my anterior column into my iliopoas muscle causing a whole bunch of new pain problems what I want to find out if anyone heard of mislabeling problems with smith and nephew packaging need help now I heard a little about it plus paying docs to use there product

  4. lavelle Reply

    I just had a hip replacement done four months ago. I went through theropy and i still can’t bare any weight on it, i have to walk with a crutch. It hurts in the front, on the side, and in the back. I don’t know what’s going on with it but i’m really scared.

  5. Kristi Reply

    I had BHR put in 3 yrs ago at age 42. I have been having pain and clunking for over 1 yr. My surgeon sort of poopooed me saying it was a tendon rubbing or something. I finally had a MARS MRI that showed I have a pseudotumor and may need to have it replaced. The fluid was aspirated and blood drawn and I am still awaiting the results. Wondering what options are out there, surgeries are expensive and I am not looking forward to the possibility of having yet another on this hip within 3 yrs.

  6. Kylie Reply

    I had a BHR done in 2002 this failed and caused major problems, this was taken out in 2007 and replaced with a smith and nephew mom hip, 4 years later in early 2012 I started experiencing extreme pain, vertigo, depression and was unable to walk, I also had extremely high cobalt and chromium levels, all X-rays and scans were showing the hip was good, surgeon finally decided to do a revision and found huge amounts of metal debri, pseudo tumors, damage to surrounding tissue and bone loss, he replaced the hip with yet another smith and nephew hip, which I am now also having problems with. I am only 35 I have been left with a leg 4cm shorter, a compressed iliac vein, swelling and discoloration to my leg and on going pain. I have 2 young children and I feel like I am 80 years old, I am so scared at the thought of more surgery as every one seems to get worse. Smith and nephew should be held accountable.

  7. Charmaine Reply

    I have a BHR in R hip from November of 2007 and a BHR in L hip from December of 2009. My Cobalt is 2.2 and my Chromium is 5.3 and I have so many issues. I have a lawyer, but they keep telling me it may never come to fruition against this company because of some agreement with the FDA. Does anyone know the details on this? I mean, how can they get away with this? I have digestive issues, thyroid issues, I have yeast infections in the gut and elsewhere (which many doctors in my area had never even heard of it happening in the gut) from low immunity and headaches, plus the R hip pops and snaps all the time and I can no longer put pressure on it for very long before it gives out. I am truly worried I won’t be compensated for this ruining my life and making it so I am unable to work. If anyone has any information, I would be grateful!

  8. Mike Reply

    I also had a Smith Nephew hip resurfacing to my right hip. I went from being an athlete to some mornings barely being able to get out of bed. Headaches, pain, numb quads, metal in my system all because a device was not properly tested.
    I am going to have surgery next week and currently have an attorney (john) who specializes in medical issues reviewing my case.
    Im not going to stop and at some point in time may have John file a class action suit.

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