Metal on Metal warning (old but ongoing news)
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Poppet
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Date Issued: Jan. 17, 2013
The FDA has recently issued new guidelines for patients implanted with metal-on-metal hip implants. The FDA is also looking to impose stricter regulations for the implants requiring manufacturers to show that they are safe and effective before selling them.
The FDA Guidelines: broken link removed: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm
Separate to The Metal on Metal issue.. or is it...?
Australian Department of Health and Ageing announced in the 2012-13 Budget that it will remove joint replacement prostheses with evidence of higher than acceptable revision rates from the Prostheses List, so that private health insurers are no longer required to pay benefits for those prosthetics.
The FDA has recently issued new guidelines for patients implanted with metal-on-metal hip implants. The FDA is also looking to impose stricter regulations for the implants requiring manufacturers to show that they are safe and effective before selling them.
The FDA Guidelines: broken link removed: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm
Separate to The Metal on Metal issue.. or is it...?
Australian Department of Health and Ageing announced in the 2012-13 Budget that it will remove joint replacement prostheses with evidence of higher than acceptable revision rates from the Prostheses List, so that private health insurers are no longer required to pay benefits for those prosthetics.
Thanks for the updates, I wonder what is an acceptable rate in Australia? In the UK the Orthopaedic Data Evaluation Panel (ODEP) an NHS Supplies Agency - evidence based listing of devices. Tlhis came out of the problem of the 3 M hip about 10 years ago following reviews by Royal College of Surgeons, Naitonal Audit Office etc. Their recommendation for a good grading was less than 5% failure rate at 5 years and 10% at 10 years. Hospitals are not supposed to purchase unlisted or low graded devices. Yet many do!
And guess what. When I worked for Synthes we were given a few shares. When J & J (DePuy) bought Synthes last year I received 66 J & J shares as part of the deal - I sold the J & J shares two days ago 
Josephine
NURSE DIRECTOR EMERITA
A recent report from the FDA giving the recommendations for MoM hips Metal-on-Metal Hip Implants: FDA Safety Communication
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New research about women and THR, the study will be out soon.
broken link removed: https://www.cbsnews.com/8301-204_162-57569956/hip-replacements-more-likely-to-fail-in-women-says-study/
broken link removed: https://www.cbsnews.com/8301-204_162-57569956/hip-replacements-more-likely-to-fail-in-women-says-study/
Josephine
NURSE DIRECTOR EMERITA
I think this article needs some dissection to get at the truth. It is not all it seems to be from the title:
Women were almost 30 percent more likely than men to need a repeat surgery within the first three years. It's not known which models of hip implants perform best in women, even though women make up the majority of the more than 400,000 Americans who have full or partial hip replacements each year to ease the pain and loss of mobility caused by arthritis or injuries.
"Partial" hip replacements refers to hemiarthroplasties, the surgery carried out for fractured necks of femur or broken hips. If the injury occurs in a younger, fitter patient, it's almost inevitable it will require conversion to a total hip replacement in short time. It's becoming more common for such fractures to be treated with a THR straight away in the younger patient (<70). Including these in the study 'massages' the figures tremendously.
After an average of three years, 2.3 percent of the women and 1.9 percent of the men had undergone revision surgery to fix a problem with the original hip replacement. Problems included instability, infection, broken bones and loosening.
Nothing new here - this has been known for years.
Co-author Dr. Monti Khatod, an orthopedic surgeon in Los Angeles, speculated that one factor may be a greater loss of bone density in women. He adds that overall it's a very safe surgery, with 97 percent of implants surviving at 5 years. In general, he'd expect that rate to fall to about 85 percent after 10 years.
And regarding MoM hips
The failure of metal-on-metal hips was almost twice as high for women than in men, according to the study. The once-popular models were promoted by manufacturers as being more durable than standard plastic or ceramic joints, but several high-profile recalls have led to a decrease in their use in recent years.
In June 2012, a panel of experts advising the FDA concluded that there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to potentially toxic metal particles.
That followed similar findings out of the U.K., where researchers looked at national registries and found more people with MOM implants needed surgery to fix or remove the implants within five years, compared with those who had ceramic or plastic joints.
And a final comment with which I would heartily agree!
"Don't be fooled by hype about a new hip product," said Diana Zuckerman, president of the nonprofit National Research Center for Women & Families, "I would not choose the latest, greatest hip implant if I were a woman patient. ... At least if it's been for sale for a few years, there's more evidence for how well it's working."
Women were almost 30 percent more likely than men to need a repeat surgery within the first three years. It's not known which models of hip implants perform best in women, even though women make up the majority of the more than 400,000 Americans who have full or partial hip replacements each year to ease the pain and loss of mobility caused by arthritis or injuries.
"Partial" hip replacements refers to hemiarthroplasties, the surgery carried out for fractured necks of femur or broken hips. If the injury occurs in a younger, fitter patient, it's almost inevitable it will require conversion to a total hip replacement in short time. It's becoming more common for such fractures to be treated with a THR straight away in the younger patient (<70). Including these in the study 'massages' the figures tremendously.
After an average of three years, 2.3 percent of the women and 1.9 percent of the men had undergone revision surgery to fix a problem with the original hip replacement. Problems included instability, infection, broken bones and loosening.
Nothing new here - this has been known for years.
Co-author Dr. Monti Khatod, an orthopedic surgeon in Los Angeles, speculated that one factor may be a greater loss of bone density in women. He adds that overall it's a very safe surgery, with 97 percent of implants surviving at 5 years. In general, he'd expect that rate to fall to about 85 percent after 10 years.
And regarding MoM hips
The failure of metal-on-metal hips was almost twice as high for women than in men, according to the study. The once-popular models were promoted by manufacturers as being more durable than standard plastic or ceramic joints, but several high-profile recalls have led to a decrease in their use in recent years.
In June 2012, a panel of experts advising the FDA concluded that there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to potentially toxic metal particles.
That followed similar findings out of the U.K., where researchers looked at national registries and found more people with MOM implants needed surgery to fix or remove the implants within five years, compared with those who had ceramic or plastic joints.
And a final comment with which I would heartily agree!
"Don't be fooled by hype about a new hip product," said Diana Zuckerman, president of the nonprofit National Research Center for Women & Families, "I would not choose the latest, greatest hip implant if I were a woman patient. ... At least if it's been for sale for a few years, there's more evidence for how well it's working."
I think this is the clinical report of this paper:
Study: Women have higher THA revision rates than men
“The role of sex in relationship to implant failure after hip arthroplasty is critically important for patient management and device innovation but current evidence is limited,” Maria C.S. Inacio, MS, of the Surgical Outcomes and Analysis Department, Southern California Permanente Medical Group in San Diego, told Orthopedics Today. “Using a cohort of 35,140 hip arthroplasties from a U.S. Total Joint Replacement Registry, the risk of revision in females compared to males was evaluated. After considering patient, surgical, surgeon, volume and implant-specific risk factors, females had a 29% higher risk of implant failure than males in this community-based sample.”
Inacio and colleagues studied registry data from 46 hospitals and 319 surgeons collected between 2001 and 2010. Women encompassed 57% of this study, and those women had more 28-mm femoral heads (28/2% vs. 13.1%), more metal on highly crosslinked polyethylene bearing surfaces (60.6% vs. 53.7%) than men, according to the abstract.
At median 3-year follow-up, women had a 1.29 all-cause hazard ratio for revision compared to men, a 1.32 hazard ratio for aseptic revision and 1.17 hazard ratio for septic revision, according to the abstract. Implant survival at 5 years was also higher in women than in men.
Reference:
Inacio MCS. JAMA. 2013;doi:10.1001/jamainternmed.2013.3271.
Josephine, I am surprised at your comment that increasingly THRs are being used for younger fracture neck of femur patients. Local experience indicates that this depends on the place of fracture, frailty of the patient and not so much on age. It is important that the surgeon matches his surgery to that patient and pays less attention to patient's age. However, I agree that many hemiarthroplasties (endoprostheses) go on to a THR. As you know there is a very high mortality rate in such patients - 10% at 30 days and likely up to 30% at a year. More importantly about 50% of such cases do not return to their home. Prevention of falls is a very important issue with older vulnerable patients.
Study: Women have higher THA revision rates than men
- February 19, 2013
“The role of sex in relationship to implant failure after hip arthroplasty is critically important for patient management and device innovation but current evidence is limited,” Maria C.S. Inacio, MS, of the Surgical Outcomes and Analysis Department, Southern California Permanente Medical Group in San Diego, told Orthopedics Today. “Using a cohort of 35,140 hip arthroplasties from a U.S. Total Joint Replacement Registry, the risk of revision in females compared to males was evaluated. After considering patient, surgical, surgeon, volume and implant-specific risk factors, females had a 29% higher risk of implant failure than males in this community-based sample.”
Inacio and colleagues studied registry data from 46 hospitals and 319 surgeons collected between 2001 and 2010. Women encompassed 57% of this study, and those women had more 28-mm femoral heads (28/2% vs. 13.1%), more metal on highly crosslinked polyethylene bearing surfaces (60.6% vs. 53.7%) than men, according to the abstract.
At median 3-year follow-up, women had a 1.29 all-cause hazard ratio for revision compared to men, a 1.32 hazard ratio for aseptic revision and 1.17 hazard ratio for septic revision, according to the abstract. Implant survival at 5 years was also higher in women than in men.
Reference:
Inacio MCS. JAMA. 2013;doi:10.1001/jamainternmed.2013.3271.
Josephine, I am surprised at your comment that increasingly THRs are being used for younger fracture neck of femur patients. Local experience indicates that this depends on the place of fracture, frailty of the patient and not so much on age. It is important that the surgeon matches his surgery to that patient and pays less attention to patient's age. However, I agree that many hemiarthroplasties (endoprostheses) go on to a THR. As you know there is a very high mortality rate in such patients - 10% at 30 days and likely up to 30% at a year. More importantly about 50% of such cases do not return to their home. Prevention of falls is a very important issue with older vulnerable patients.
Another bit of the top story currently:
DePuy issues field safety notice for ADEPT 12/14 metal modular head
February 18, 2013
DePuy, a Johnson & Johnson company issued a field safety notice dated Jan. 15 for physicians and consumers for the ADEPT 12/14 Modular Head used in total hip replacement after reviewing its revision rates in the U.K. National Joint Registry Supplier Feedback data and the Australian Orthopaedic Association National Joint Replacement Registry.
The notice does not apply to the ADEPT broken link removed: https://www.healio.com/orthopedics/search?q=%22hip%20resurfacing%22&requiredfields=specialty:Orthopedics femoral components, according to a DePuy spokesperson. The recall, however, involves 7,700 implants sold in 21 countries, including the United Kingdom, Germany, Denmark, Australia and Canada. The heads were not sold in the United States.
Finsbury Orthopaedics Ltd. designed, developed and manufactured the ADEPT 12/14 Modular Head in 2004. DePuy acquired the firm in 2009 and then the products were acquired by MatOrtho Ltd. in 2011. DePuy issued the field safety notice due to its responsibility for monitoring ongoing performance of the product.
“Customers have been advised through the field safety notice to discontinue use and distribution of any ADEPT 12/14 Modular Heads they may still have in stock,” the DePuy spokesperson told Orthopedics Today.
The implant has a cumulative revision rate of 12.1% at 7 years, according to results DePuy officials analyzed from U.K. National Joint Registry Supplier Feedback data in November 2012. In the Australian Orthopaedic Association National Joint Replacement Registry, registry officials reported a 7.1% cumulative revision rate for the modular head at 3 years when used in total hip replacement, according to an analysis done in September 2012.
“Patients who received the ADEPT Modular Head should follow up with their doctor if they are experiencing symptoms and be treated according to local guidance/standard of care for patients receiving metal-on-metal articulations,” the DePuy representative stated. “DePuy has notified customers and appropriate regulatory agencies,” according to the spokesperson.
Reference:
broken link removed: https://www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con222579.pdf
DePuy issues field safety notice for ADEPT 12/14 metal modular head
February 18, 2013
DePuy, a Johnson & Johnson company issued a field safety notice dated Jan. 15 for physicians and consumers for the ADEPT 12/14 Modular Head used in total hip replacement after reviewing its revision rates in the U.K. National Joint Registry Supplier Feedback data and the Australian Orthopaedic Association National Joint Replacement Registry.
The notice does not apply to the ADEPT broken link removed: https://www.healio.com/orthopedics/search?q=%22hip%20resurfacing%22&requiredfields=specialty:Orthopedics femoral components, according to a DePuy spokesperson. The recall, however, involves 7,700 implants sold in 21 countries, including the United Kingdom, Germany, Denmark, Australia and Canada. The heads were not sold in the United States.
Finsbury Orthopaedics Ltd. designed, developed and manufactured the ADEPT 12/14 Modular Head in 2004. DePuy acquired the firm in 2009 and then the products were acquired by MatOrtho Ltd. in 2011. DePuy issued the field safety notice due to its responsibility for monitoring ongoing performance of the product.
“Customers have been advised through the field safety notice to discontinue use and distribution of any ADEPT 12/14 Modular Heads they may still have in stock,” the DePuy spokesperson told Orthopedics Today.
The implant has a cumulative revision rate of 12.1% at 7 years, according to results DePuy officials analyzed from U.K. National Joint Registry Supplier Feedback data in November 2012. In the Australian Orthopaedic Association National Joint Replacement Registry, registry officials reported a 7.1% cumulative revision rate for the modular head at 3 years when used in total hip replacement, according to an analysis done in September 2012.
“Patients who received the ADEPT Modular Head should follow up with their doctor if they are experiencing symptoms and be treated according to local guidance/standard of care for patients receiving metal-on-metal articulations,” the DePuy representative stated. “DePuy has notified customers and appropriate regulatory agencies,” according to the spokesperson.
Reference:
broken link removed: https://www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con222579.pdf
Josephine
NURSE DIRECTOR EMERITA
Absolutely and thank you for picking me up on this. It's one of those "well, I know what I mean" statements! Of course I was referring to subcapital fractures which are the type of fractures treated by hemiarthroplasty. But yes, younger people do get subacp # (see Suzieslps) and they often have problems with them so (when I was last in theatre!) there was a general move towards using a THR rather than a hemi. But using this group of patients in this study is, in my 'humble' opinion, inappropriate to the end objective. They are chalk and cheese.
And yes, there is a high mortality rate in subcap # however they are treated (hemi, pins or DHS). A study I was once involved in revealed that an average of 40% of such patients did not survive past one year. However, it should be remembered that an inordinate number of these patients were 80+ and therefore while one could connect their demise with the accident in starting a downward spiral of wellness, it was not necessarily connected with the surgery.
Thanks Josephine. The best papers in the use of THR for fractured neck of femur patients (#NOF) are from scandinavian countries. With regard to the high mortality after such NOF patients the variation is not just on age but whichever co-mobitities are present.
Well it looks as if cases are coming home to roost.
see: https://www.healio.com/orthopedics/hip/news/online/{8AB11320-68B9-4132-825E-B49401B66D08}/Jury-awards-plaintiff-83-million-in-DePuy-ASR-XL-hip-recall-trial
Jury awards plaintiff $8.3 million in DePuy ASR XL hip recall trial
March 11, 2013
DePuy Orthopaedics, a Johnson & Johnson company, was ordered to pay $8,338,000 in compensatory damages to 65-year-old Loren “Bill” Kransky after a jury found the company’s ASR XL total hip component was defectively designed.
see: https://www.healio.com/orthopedics/hip/news/online/{8AB11320-68B9-4132-825E-B49401B66D08}/Jury-awards-plaintiff-83-million-in-DePuy-ASR-XL-hip-recall-trial
Jury awards plaintiff $8.3 million in DePuy ASR XL hip recall trial
March 11, 2013
DePuy Orthopaedics, a Johnson & Johnson company, was ordered to pay $8,338,000 in compensatory damages to 65-year-old Loren “Bill” Kransky after a jury found the company’s ASR XL total hip component was defectively designed.
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I think this is going to be a big mess for J & J as more information comes to the fore front.
Poppet
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Finally...
https://www.tga.gov.au/industry/devices-reforms-joint-implants-2012.htm
(admin edit: This article no longer exists)
https://www.tga.gov.au/industry/devices-reforms-joint-implants-2012.htm
(admin edit: This article no longer exists)
