Stryker Corp. issued a recall of its Trident Hip Implants last month, just days after the Food & Drug Administration (FDA) posted a warning letter on its website chastising Stryker for deficiencies at its New Jersey manufacturing plant. The Stryker hip implant components involved in the January recall were manufactured at the company’s manufacturing facility in Ireland, which was also the subject of an FDA warning letter earlier this year.
The FDA decided to take a hard look at Stryker after receiving an unusually high number of complaints from recipients of Stryker hip implants. Since 2005, Styker hip implant patients have reported a range of problems, including pain, difficulty walking and “squeaky” joints, and some have had pieces of implant parts break off or wear down unevenly. Those complaints prompted the FDA to inspect both the Mahwah, New Jersey and Cork, Ireland plants where most of the Stryker hip implants sold in the US are made. Those inspections resulted in the FDA issuing Stryker two warning letters.
The first, a seven-page letter dated March 15, 2007, cited several violations at the Ireland plant, including missed deadlines to fix failures in following procedures for testing problematic products and documenting risk. The heavily redacted letter refers to an earlier voluntary recall of “hip fracture stems” which appears to be related to the problems. It also cited several instances where the “root cause” of problems that caused that particular recall was not determined.
Then Stryker received another letter regarding the New Jersey facility. That letter, dated November 28, 207 said that the deficiencies uncovered during an inspection at the Mahwah, New Jersey facility had contributed directly to the manufacture of faulty hip implants. The FDA letter described a range of deficiencies, including “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections, that was found throughout the plant. The November 28 letter states repeatedly that Stryker “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” For instance, in regards to the bacterial contamination, the letter states that Stryker “has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”
Stryker’s problems came to a head on January 22, 2007, when the company issued a recall for more hip implant components made in the Cork, Ireland plant. The latest Stryker Hip Implant component recall involved two hip replacement cups – the Trident Acetabular PSL Cup and the Trident Hemispherical Cups – made at the Stryker facility in Cork, Ireland. Acetabular Cups are used in the socket portion of replacement hip components. The PSL version is the most commonly used Stryker cup in the U.S.
The Trident Hip Implant cup recall was implemented by Stryker amid concerns that the components could be contaminated with “manufacturing residuals” at levels that exceed company standards. However, Stryker maintained that the problems did not affect the sterility of the components, and claimed that patients who have received the recalled Trident components will not need to have them replaced.
Just a few days after the Stryker hip implant recall, Stryker President and CEO, Stephen P. MacMillan assured investors that there was no clinical evidence to suggest safety problems with the company’s products. In his remarks, MacMillan did not mention all of the complaints Stryker received from its hip implant recipients. Still, even he had to concede there are serious problems at Stryker. “You don’t get two letters in nine months and feel good,” MacMillan told his audience.
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June 2nd, 2009 at 10:19 am
I have had both hips replaced with the afore mentioned Stryker trident devices and had nothing but trouble since. The latest one, done in 8/07 has been almost unbearable since performed. The orthopedic surgeon just blows me off with “the x-rays look good” and doesn’t want to hear anything. I am now forced to see another DR. in another city. In the last 2 months, the hip I received in 2006 has become horribly painful now too. I am only in my 50’s and I can hardly walk. I wonder if anyone else out there has had similiar problems?
July 15th, 2009 at 5:44 am
I had a hip replacement with Stryker Trident device in January 2008. Have continued to have some pain but hoped it will go away eventually. However, it has got much worse in the last two months, now I could hardly walk for five minutes. Wondering what to do and if there is any use in going back to the surgeon – after reading your experience!
July 15th, 2009 at 5:44 am
I had a hip replacement with Stryker Trident device in January 2008. Have continued to have some pain but hoped it will go away eventually. However, it has got much worse in the last two months, now I could hardly walk for five minutes. Wondering what to do and if there is any use in going back to the surgeon – after reading your experience!
August 12th, 2009 at 8:33 am
I had a hip replacement with stryker trident device in january 05, started hearing squeeking in june 06, went to see orthopedist who did surgery, advised me some patients were experiencing same, however, was not sure why, never advised me of recall. I have pain in leg all the time, hard for me to walk sometimes, I am so afraid of another surgery, after everything I have gone through.
August 17th, 2009 at 3:13 pm
I received total right hip in March 2008 it was great for about eight months, then the squeaking started, then the popping and now both. I am having pain with xtended walking sessions. I also work in an ER for 12 hrs at a time. I wish someone could help us resolve these issues!
September 29th, 2009 at 8:04 am
My hip was replaced January of 2007. It started the popping noise as if it was going to pop out about 6 months later and in November 2008, I called my doctor about the sqeaking and was told there was nothing to do about it. If it gets worse to take an xray. The sqeaking is now non stop and embarrassing. It is also has started aching. As much as I would not like to go through the surgery again, I also am only in my 50’s and do not want to squeak as I walk the rest of my life. Maybe the Tin Man has some suggestions!I also was not told there was a recall.
October 4th, 2009 at 10:25 am
I had a total Right Hip Replacement on June 6, 2005. I am now 56 and I have been in PAIN since the Replacement has been done. The doctor tells me it is in my head. The pain in my hip is so painful, I have a hard time walking! I have been through Therapy for my hip various times. The Pain Never goes away. Something has to be wrong but no one wants to listen! I had never been told of a recall, just told I was crazy! I hope some of these doctors that are doing these surgeries start listening to patients for a change. We do know what pain is! Live in our Body for a Day! I guarentee you would not live with this kind of pain everyday of your life.
November 10th, 2009 at 9:23 am
I am a 50 year old male and have had both hips replaced, The first in 1997 and the second in 2007.
The 1997 replacement is perfect, I forget that I’ve had it done, the 2007 was horrible! and I say was because last month I had it replaced. After almost two years of horrible pain and popping Vicoden like breathmints, I called Stryker to inform them of my problem, they were actually quite nice. I signed a medical records release and told them that I was scheduled to have the revision surgery. After two months of waiting, I received a call from Stryker four days before surgery telling me that their independent orthopedic surgeon has diagnosed my condition as Bursa Tendonitis and advised me not to have the surgery. Yea right! I took my surgeons advice and went ahead with the revision. when he opened my hip, the Stryker Trident Heispherical acetabular cup fell right out of the pelvis and into his hand. Pathology reports indicate that zero bone cells were identified on the shell. After 2 years and no bone growth, the only possible answer is contamination. Now Stryker is hiding behind a United States Supreme Court ruling; Riegel vs Medtronic, Inc. (2008) stating that they are peempted from lawsuits by section 360k(a) of the Medical Device Amendments of 1976. What cowards! By the way the new hip (only a month old) is fabulous. Absolutely no joint pain, what a difference and it was made by Biomet.
November 30th, 2009 at 7:42 pm
I had a Stryker hip replacement put in 2005 (L) and have been in pain since.
My right was done in 1997 and recovered in 5 weeks.
The doctor says I don’t have one of the defected models but I’m about ready to just give up! 24/7 pain, three more surgeries and I still can’t walk. I just want it gone!
They say it’s not the problem but they don’t know what is.
I am also started spontanous bleeding through my skin shortly after the replacement was put in. They don’t know what that is either but it has to be connected. Never happened before!
January 12th, 2010 at 10:55 am
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January 28th, 2010 at 7:28 am
I had a THP in November of 2008. It was done “on the early side” because my surgeon made a good case for not waiting until I was almost unable to walk. Said I would recover well, because it wasn’t so far gone and I was relatively young (65) and in good physical shape. Nothing but pain and limitations since. I am more handicapped today than I ever was by the degenerative arthritis. Almost a year into the ‘recover’, I asked for an OR report and learned with dismay that I’d had a Stryker PSL HA acetebular prosthetic. My surgeon had only told me he was giving me “the Cadillac of replacements” because of my age etc. He kept stressing that I was lucky to get it because they are so expensive. I am in Canada, and at that point did not know of the recall by Stryker. Finally, at the one year mark, after exhorting me to be patient, patient, patient, the surgeon has ordered a bone scan and WCB scan. We’ll see what they tell him, but I am thoroughly demoralized and sad that my life has taken such a downturn in terms of activity level since this surgery. I suspect that perhaps Canada kept using these hip products beyond the recall???