Smith & Nephew Hip Manufacturing Problems Result in FDA Warning
Published: December 29th, 2010
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.
Related Articles
- DePuy Orthopaedics Regulatory Problems with Hips, Knees Draw FDA Warning (1/19/2012)
- J&J Puerto Rico Plant Tied to Drug Recalls Still Has Problems: FDA (11/30/2010)
- FDA Warning Letter Over Problems with Stryker Trident Hip Implants Resolved (3/25/2010)
- Stryker Working to Resolve FDA Warning Letters (10/26/2009)
- Stryker Increases Quality Control Costs Following Hip Implant Problems (11/20/2008)
Comment by MITZI on 1 February 2011:
MY HUSBAND HAD A HIP REPLACEMENT WIITH A SMITH AND NEPHEW SPECTRUM HIP ON jULY 26, 2004.
WE LIVED IN DELRAY BEACH, FL AT THE TIME AND WERE TOLD THAT THE HIP REPLACEMENT HAD TO BE REPLACED AGAIN. THE PROBLEM WAS THAT THE STRESS MISMATCH BETWEEN THE METAL HEAD AND THE ACETABULIM. SMALL FRACTURES WERE RECCURRING AND HE WAS IN A GREAT DEAL OF PAIN.
Comment by Pete on 1 April 2011:
Just found out they recalled all the parts in question and one of those parts is in my left hip!
What a great way to start spring!
Comment by Howard on 7 April 2011:
spent 9 months in hospital due problems with Smith & Nephew BHR hip replacement. Looking for anybody or any additional information as to reported problems with this device or on going litigation. I am not an attorney. responses deeply appreciated
Comment by Barb on 15 April 2011:
Pete — Wondered what is the manufacturer of your recalled parts? Is it Smith & Nephew or a different manufacturer. Also – when did you have your hip replaced?
Comment by Rosemary on 18 April 2011:
I have 2 Smith & Nephew titantium hip replacements (2007 & 2008) Metallosis has developed around both with “lakes” of fluid causing pain, grinding & popping. Revisions have been proposed as the only solution. Does anyone know if Smith & Nephew is paying damages for these hip replacements?
Comment by Jose on 22 April 2011:
Howard and Rosemary; I just met with a New York attorney and my doctor today. I had a bhr done in 2006 and had to get it revised in 2010.
Comment by Howard on 24 April 2011:
the parts were Smith & Nephew, I had hip replaced in 2007. To my knowledge Smith & Nephew have not compinsated anyone, on record. I believe the Senate has formed a sub-committee to hear complaints as to the metal on metal hip replacements. I believe the key to pursuing litigation is have a case go through the court systems. This will enable us and attorney to see what descovery issues need be answered, in order to succeed in court.
Comment by Valerie on 28 April 2011:
I had a rt. total titanium hip replacement with the Smith- Nephew parts and I haven’t had 1 day without pain and limp!!!!! I live a life of pain and lots of sleepless nights.
Comment by Bryan on 29 April 2011:
I had a BHR done on my right hip in Feb 2009 and had nothing but problems with it since then. I went to see a revision specialist in March 2011 and he that I would need a revision surgery but because I had a resurfacing done on that hip, the chances are very high that I could lose some mobility and he is afraid to take it out because im only 27.
Comment by Howard on 6 May 2011:
Rosemary,Jose,Valerie,Bryan and anyone else with BHR(Smith&Nephew hip) I believe it is in all of our interest to have our attorneys communicate with each other. We are few in numbers compared to the DePuy patients, if our attorneys communicate with each other it will provide shared information as to discovery issues.
Comment by Howard on 12 May 2011:
where are the FDA results as to monitoring Smith&Nephews and what impact occured to the reported statistics as to the BHR, where they impacted due the payoffs to doctors. Part of the FDA approval of the BHR was to continue researching the impact of having cobalt & chromium entering the blood stream, where is this data to be found.
Comment by Carol on 18 May 2011:
I had a Smith & Nephew BSR replacement hip in March 2007 and after 5 months, had excrutiating pain which, 4 years later, was diagnosed as ALVAL. During that time I had 4 dislocations, 2 revisions and I now walk with a crutch, have lost all my abductor muscles and lots of soft tissue. I would like to take legal action but only the DePuy implant has had enough complaints to go forward with litigation. Can we start a group to go forward with this
Comment by Rosemary on 28 May 2011:
Recovering from my first hip revision – now have a polyethylene acetabular shell (Smith & Nephew R3) and a ceramic surfaced femoral head. I think I made a mistake in my original post: my hip replacements were chromium/chrome. My understanding is that these are different than the BSR which I believe is a re-surfacing, not a full replacement. Also, I think the FDA issue was a manufacturing quality control issue about radiation-sterlization. I don\’t think this would lead to the metallosis issues I had. Still looking for information about legal actions against Smith and Nephew – would love to get some $$$ for my pain & suffering related to two more major surgeries (plus all my deductibles….)
Comment by Rosemary on 28 May 2011:
Regarding a Senate inquiry: the only information I can find on line about this is from the Australian Senate. It appears that they are trying to start a Joint Replacement Registry so that all the information about manufacturer, patients, etc. is collected in one place. Looks like they had a lot of difficulty deciding who should pay for this (no surprise!) Here’s the link: http://www.aph.gov.au/senate/committee/clac_ctte/private_hth_nat_joint_replace_reg_09/report/report.pdf
Comment by debby on 2 June 2011:
i had a hip replacement done in may of 08,it was a bhr,i had a lot of pain and to my surprise it had dislocated and fallen in to my groin.i had it revised a month later.then after the revision i was still experiencing pain,i went back to the doctors and he said it was just bursitis.i continued on with my life in tremendous pain and decided i would see another dr. just for the heck of it,my limp was terrible and sleeping and bending were next to impossible.again to my surprise it had dislocated and the only way for relief was another revision,it was two years since my last two surgeries.i now have another problem,the muscle has ripped away from my hip from being cut too many times in such a short peroid of time and that not only hurts but looks hideous.my first two failed implants were smith and nephew and i am very frustrated.all of us on this site deserve answers and help,it is not only depuy,it is all metal on metal implants that need to be addressed.i think i speak for most of us when i say we need justification,we are going through the same things that the depuy patients are and we need help.i will not stop looking until someone actually stops and listens and helps.
Comment by BeeJay on 5 June 2011:
I am in similar situation and I agree 100%. I am 35 and about to have my 2nd revision from a BHR. What specifically legally is there to do since there is no recall yet? For metal on metal or Smith and Nephew? You are all in my prayers as this is what has gotten me through the past 5 yrs…
Comment by debby on 6 June 2011:
beejay i am soooo happy you asked the big question we are all thinking about and am happy to report that i just recieved the answer.in order for there to be a recall,there must be complaints formally registered with the fda,you must call and they will instruct you about what forms you will have to fill out,in a perfect world our surgeons were to have filled them out already but i am filling my own out to be on the safe side,it is our right.if everyone does this smith and nephew will be forced to comply hence order a recall….we have to take this upon ourselves and as upset as i am i have no problem doing it.i urge everyone to please do this as soon as possible so no one else has to go thru this and to get the legal ball rolling.the number for the fda is313 393 8189,i spoke to linda ritchie who was awesome and her number is 313 393 8189.if we all work together it will happen.
Comment by debby on 7 June 2011:
beejay i forgot to mention that if you maintain a good relationship with the surgeon who performed your surgeries you should call them to find out if they indeed filled out the appropriate paperwork and submitted it to the food and drug administration,if they have not,the fda will instruct you on how to proceed.i am just so tired and disgusted about this whole thing,it affects all aspects of my life.well anyway,good luck with your upcoming surgery….you are in my prayers
Comment by Howard on 19 June 2011:
I think the best way to purse legal action, if we share our course of actions, this may intern help each other. Some attorneys,and some people are waiting for a lawsuit to go through court sytems; to help inform us of discovery. I believe after the senate subcommittee hearings. The state of Texas and Ohio were to begin trying these cases against DePuy and several others. Smith & Nephew’s bhr is better than it”s competion, however the product is metal on metal, and yes there are problems. The only way justice can be served is if you speak up, hire a competent medical device attorney that will work on your case and not give the case to a bigger firm, for a contingent fee, Tell the lawyers to talk to each other re:BHR. I don’t think a lawyer or law firm has tried a case in our court systems from beginning to end.
Respectfully
Howard Sadwin
Comment by debby on 21 June 2011:
Howard you are absolutely right.The bHR is suppose to be the superior product in a pool of metal on metal products that stemmed from a very stupid idea,stupid from a patients perspective,brilliant from a pharmaceutical point of view,they have made billions with these new innovative systems..Unfortunately,Whats good for them is not always good for us and i am proof of that as are thousands of others.I have been turned away by alot of attorneys because of the precise reasons you have laid out..I think being the first suit against smith And Nephew will be a nail biter,with alot of folks watching from the sidelines,Everyones scared to be that case and to take that plunge,but one of us will be that very first case….maybe me….maybe not.I agree with you that finding a good medical device attorney is paramount,I also believe that it will be a smaller firm to dive in,The problem that we face is that not too many firms are familiar with these products and are not willing to go to the expense and possibly the waste of their time researching our individual cases, have been told everything from just be patient and wait for a recall then call us to we have not heard that through the grapevine about smith and Nephew and to keep checking online for updates…that is disheartening.I think the food and drug administration acted hastily giving them the ok based on 124 -rays and virtually no follow up.From my understanding the fda wants something in writing now from multiple companies that are coming under scrutiny to support their claims of safety,i think when there billions of dollars at stake people tend to lose chunks of their soul,am i rotten to not trust these companies about not reporting the gospel truth…i think keepin it real does not apply to them.Howard,How do we have our attorneys contact each other…I think everyone is unclear whether it is wise to post online who is representing everyone if at all because of damage control on Smith and Nephews part,i mean they will find out eventually so i am guessing it doesnt matter.I personally do not have an attorney as of now,there is a firm that is willing to take a look at my situation,there is a medical device specialist there so i may go for it,what is my alternative.Thankyou for giving advice to a lost crowd,any future advice would be appreciated,without a law degree we dont know what to do and what not to do.Thankyou
Comment by Karen on 28 July 2011:
Hi all! Just found this site after my appointment with a second opinion ortho surgeon. He flat out told me I would have to find a doctor outside my state (California) if I wanted to pursue a lawsuit because it is so time-consuming and no San Diego ortho surgeon would testify against “one of their own”. I think I have 2 situations with my Smith/Nephew parts. I do have metal on metal parts AND my surgeon told my husband he had to put in a larger cup than he wanted because I had lost too much pelvic bone to properly hold a smaller cup. I’ve been in constant pain since surgery: left hip 9/4/08, right hip 11/4/08, then revision because surgeon made right leg an inch longer than left! I freaked out and insisted he re-do it! So on 11/14/08 he did a “revision” – he never apologized and just expected my insurance to pick up the additional $100,000 tab for the revision! Luckily they did!!! My iliopsoas tendon is rubbing along the side of the cup every time I move, causing sharp, excruciating pain. Been on Norco (vicodin & acetomenephin) 4x a day for almost 3 years now! YUCK! New doc recommending I have a bone scan to confirm what’s going on and then possibly a blood test to determine amount of metals in my blood. I will keep watching this site and hopefully joining all of you in suing the pants off this company and getting some $$$ compensation for all the years of pain and suffering we’ve been through! Our quality of life should be worth something!!!!!
Comment by howard on 3 August 2011:
I have continued learning about Smith & Nephew, in my quest to see justice is done.
The only way I have communicated with other patients and attorneys is through the e-mail or by phone.
We need a stronger communication group; Smith and Nephew has perhaps already damaged our lives, what more can they do? Unless we retalliate as a group, the war will be unneccessarily burdensome.
Comment by Bryon on 3 August 2011:
I had a bhr done on my right hip oct. 2009. As i was rehabing 2 months into my rehabilitation . I was having severe back problems. march of 2010 i needed a spinal fusion. Still having hip pain sitting or walking i do have fair days but between my back pain because of back spasms and and fusion. I am being out worked by an 84 year old man that has hip and back pain of his own.Not sure if the spinal fusion was caused by the surgery or maybe the rehabilaton process having more pressure on my spine to keep my hip from hurting so bad. Still have problems with my hip and back both. I forgot to mention i’m also 38 . To young to not be active and being able to barely walk a mile. i also have problems sleeping and suddenly feel more natious like i’m feel sick and vomiting . I can never get comfortable for to long sitting or standing. I feel all your pain it sucks.
Comment by Karen on 16 August 2011:
Follow-up to my July 28 post: just came back from 2nd opinion ortho surgeon and it is confirmed that on my left hip the surgeon did do a metal on metal implant, while on the right hip there is composite lining separating the metals so no problem. And cobalt-chromium blood test confirmed HIGH levels of these metals floating around in my body causing kidneys to overwork and eventually FAIL! Only solution is to have a revision on the left hip!!! My stomach flips every time I remember the pain after surgery and the long recovery time! But this will eventually kill me if I don’t get it corrected. 2nd opinion surgeon urges me to NOT WAIT longer than 6 months. So how do I AND all of us, get Smith & Nephew to pay for our suffering and damages to our bodies AND our lives??? I’m in San Diego County, California.
Comment by mike on 2 September 2011:
Wow- just scheduled my revision surgery (now a total hip replacment) due to failure of the Smith & Nephew BHR which I received Feb 2. 008. Have been in pain for 2 1/2 years with varying diagnoses of lower back, sciatica, stress, etc; but no one ever agreed it was my hip until it “popped” last Sunday. My initial implemenation involved a S&N BHR with “screws” holding the cup in place. Now 1 of the screws has broken off from cup, the cup is protruding into pelvic region, and the pain is unimaginable.
As all of you know, not much choice for any of us but to go thru surgery again. BUT- shouldn’t there be some class action available to us? 3 yeaers of suffering, now another surgery with higher incidence rate, more time off, more out of pocket expense, impact on rest of my life…….
Comment by stephen on 4 October 2011:
hello, i have had both hips replaced 1 in may 2006 and september 2006.has anybody experienced internal bleeding for a mucle or hip problem? trying to figure out what caused the pain and bleeding.steve
Comment by Terry on 6 October 2011:
I am a 55 Yo female who had a total Hip replacement on the right side —I felt great for 2 1/2 months then the night pain set in Hot spots around the hip with pain, clicking, and swelling. I wobble when I walk and I am not a weeble.. I am trying to work as a social worker but this is becomming increasingly difficult. I feel if I am on a stilt on the right side.
Now here is a part I dont know about I am having increasingly difficulty with bowel and bladder problems– Could this be from MOM poisoning???Trying to get educated on this problem. I am in New York State
By the way I love my surgeon and his practice but I am scared
Comment by Linda on 10 October 2011:
My husband had a total hip (left) replacement in 2009. He went through extreme pain and falling down for over a year. His left leg is now 1 inch shorter than the other. He is only mobile using a walker or in a wheelchair. This is a nightmare that just has not ended.
Comment by Jace on 20 October 2011:
I had both BHR done in 2008. One with S & N the other with Wright. Just had a revision done on the Wright, left side, came loose…. had it done in August and just started playing racquet ball again a couple of weeks ago…. still some pain but not bad. My right side, S&N has been poppnig and grinding for the last year ++ so I am going to have the fluid around my joint checked for metal. No pain in the hip, so I am hoping no issues with metal…. we will see. The wright has had problems with failures…. 18%…. so if anyone has a Wright Conserve… let me know….
Comment by Faye on 3 November 2011:
I had 3 surgeries since July 2008 (2) and 2009 (1), 2008 were partial hip replacenets and 2009 was to complete the 2008 surgery and make it into a total hip replacement. Smith/Nephew parts were used. The 2008 surgeries were Skryer. I have not had a pain free day since July 2008. A year ago I started burning in my urinary tract. I went to all kinds of doctors and was told all kinds of things that could be wrong. The orphpedic doctors
always said I had bursities. I never stop burning or my hip never stops hurting.. My cobalt level is 11.9 and chromim is 3.4. I have no quality of life now because of the pain. I have metal on metal and chips of metal are in my bloodstream. I need HELP, HELP, HELP.1-
Comment by Debby on 25 January 2012:
Hi everyone!I just wanted to know how everyone is doing and if anyone is willing to share up-dates?I’m still suffering..After the second revision i developed terrible back problems and my hip is still caved in..i require pain management and it doesn’t work half of the time…Smith and Nephew has ruined my life..I am severely depressed because of everything that has happened….The f.d.a. recently released a statement that read”All Metal On Metal implants Unsafe..Device design flaw”..shouldn’t that be enuff for us to take legal action??
Comment by barbara on 26 January 2012:
My husband had bi-lateral replacement in march and august of 2004 with the Smith and Nephew, he has had numerous complaints since. We have consulted with an orthopedist who scheduled corrective surgery and my husband got spooked. This has been a nightmare for him and myself. He cannot make it without pain management. Has this manufacturer claimed responsibility? The government should make them take responsibility for the lives they have ruined!!!
Comment by Larry on 27 January 2012:
I recently found this sight and would like to correspond with someone who may have information regarding a lawsuit and other info about the FDA. My surgery was a Total hip replacement using the Smith and nephew BHR -metal on metal. It was performed in 2009 and I now have pain in my groin and leg as well as swelling in the groin.I have been referred to a surgeon to check my metals count in my body -also a bone scan. Difficulty in walking and sleeping. I am at a total loss with all of this and feel like someone needs to provide answers. Did anyone contact the lawyers to provide info? The lawyers representing our particular cases? Who can we turn to? What have the rest of you done? Thanks for any direction you can provide me . Is there really an investigation into all of this?
Comment by Bryan on 1 February 2012:
I contacted 2 law firms, one in 2010 and another in 2011 about issues with my Smith and Nephew BHR replacement in Feb 2009. Neither of these law firms would touch it because I have a Smith and Nephew product. Thats what all of us have, questions with no answers.
Comment by Richard on 9 February 2012:
I had a hip replacement and after 2 years I am experiencing constant pain causing sleepless nights. More recently i am starting to limp.In a sitting position causes extreme pain and walking up steps is becoming more difficult as each month passes.
Comment by L. D. on 13 March 2012:
Had resurfacing in 2007, have had constant burning in joint ever since, was told bursitis. x-rays seem to show no dislocation and according to Doc perfect alignment. So he wasn’t sure why the pain. Never had any blood work. Also located in New York state. Any suggestions?
Comment by mary on 22 March 2012:
I had smith-nephew total hip synergy system and reflections ceramic in 2005. In 2008 had a revision for questionable ball fracture and large hematoma in hip joint. Now 2012 have severe pain and may need another revision, possible ball fracture. This seems like product failure
Comment by Judith on 5 April 2012:
My husband had a Smith & Nephew (metal on metal) hip replace in August 2010. He is still on pain medication for terrible hip and groin pain. We visited with his surgeon 5 weeks ago and he explained to us that my husband is now going to have to have corrective surgery. He is scheduled for surgery June 15th. THe more I read about this, the more infuriated I have become. This morning I contacted an attorney who is willing to take our case. I believe strength is in numbers and that we all have to stick together in this to make sure those that are suffering are helped and reimbursed for what has been done to their bodies through low grade and faulty devices. I have informed FDA of my husbands’ problems. Good Luck to everyone.
Comment by larry on 19 April 2012:
I like all of you have had serious complications with the BHR smith and nephew products and now need a revision for my metal on metal implant. Can anyone help with where we are with all of this? I am in NY
and have decided to use a different surgeon for the revision- would like a reposnse from anyone with specific info on litigation, fda, where to turn for HELP!!!!!! What has your research found out???? Thanks
Comment by Cindy on 21 April 2012:
I’m a 38 year old female that had both hips replaced and have had ongoing complications. I had my left THR metal on metal Smith & Nephew 11/09 after a scope discovered I had arthritsis that could not be corrected arthiscopically. From the moment I woke up in recovery I felt horrible, after 6 weeks of PT pain was worse. After 2 sono guided cortisone injections, MRI & CAT scan which showed everything was fine Dr & I agreed to revision to swap hardware w/ poly liner & oxium coated ball. I elected to have surgery because after 9 months pain was worse & pain in my right hip was unbearable. I had left revision in 8/10 & noticied the burning pain subsided in recovery. My doctor said pathology report showed I was having an allergic reaction to the metal on metal. I had right THR w/ poly liner & oxium coated ball 10/10. For the most part recovery for both was good, I was happy w/ results for 1st 9 months. When 1 year anniversary came I started having groin/thigh pain again, mostly in left hip that originally had metal on metal??? Right hip is ok in comparision but not what I had hoped for. When I went to my 1 year check up & spoke to my Dr he was baffled, walked out w/ script for pain meds & ibuprofens. I’ve seen many recalls for other brands but this was the 1st place I’ve seen any info regarding issues w/ Smith & Nephew. I had all my surgeries at HSS New York, NY & was very satisified w/ my Physician & the hospital, unfortunately not the outcome.
Comment by Alison on 26 April 2012:
I had 2 Smith and Nephew BHRs in 2008 and one revision in late 2010 and will have the other revised July 2012. We contacted several attorneys around the country with several wanting my case but we decided on Lee Murphy in Houston. They will actually be the ones to file our suit. Email me if you have other questions.