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As Published on the DePuy Hip Replacement Recall Website
Hip replacement surgery is a common procedure with
250,000 surgeries occurring annually in the United States.
Only 1-3 percent of those procedures will require
corrective surgery. This small population should be
manageable for regulators to quickly identify and track
defective hip replacements. It is unfortunate that the U.S.
does not have any type of national artificial joint
registration implemented. This lack of a regulatory system
along with the prolonged amount of time it takes for a hip
replacement to malfunction has allowed DePuy to sell
93,000     hip   replacements    worldwide    unregulated.
Consequently, the DePuy hip recall has caused deleterious
effects to thousands of recipients. In addition to that,
DePuy is also under fire because of the alleged ‘kickback
scandal’ reporting of the company paying consultants to
make them use its products exclusively.
Australia and the United Kingdom were able to immediately
detect the presence of defective hip implants because they
were fortunate enough to have artificial joint registries in
place. As early as 2007, the National Joint Replacement
Registry in Australia reported higher than normal failure
rates of the DePuy hip replacements. By 2009, DePuy
voluntarily withdrew its products from the market. In a
similar situation, the National Joint Registry of England and
Wales was also prompt in discovering defective hip
replacements. A study performed by English researchers at
Oxford University showed that 3.4 percent of patients out
of 660 who received DePuy metal hip implants experienced
signs    and    symptoms     associated     with   metallosis.
Comparatively, the studies also showed that 155 patients
who received a competing manufacturer’s hip implants
were examined and did not exhibit any similar side effects.
Around the same time, the U.S. Food and Drug
Administration    received    several   hundreds     of
complaints regarding metal-on-metal implants, but
took no action due to the lack of a regulatory national
registry.   Although many surgeons have stepped
forward, claiming that they immediately alerted DePuy
about complications from their defective hip implants,
their claims were met with little to no response. The
public was not aware about the seriousness of this
issue until the media began reporting about DePuy’s
higher than normal failure rates in 2010. Public outcry
in 2010 from media reports about the high failure
rates of the DePuy implants along with pressure from
the FDA finally forced DePuy to initiate a recall in
August of 2010.
The orthopedic manufacturer knew
of its defective products and
avoided initiating a DePuy hip
replacement recall .It has shown a
blatant disregard for the health and
safety of its consumers.

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ASR Manufacturer Avoided Initiating a Recall for Implants

  • 1. As Published on the DePuy Hip Replacement Recall Website
  • 2. Hip replacement surgery is a common procedure with 250,000 surgeries occurring annually in the United States. Only 1-3 percent of those procedures will require corrective surgery. This small population should be manageable for regulators to quickly identify and track defective hip replacements. It is unfortunate that the U.S. does not have any type of national artificial joint registration implemented. This lack of a regulatory system along with the prolonged amount of time it takes for a hip replacement to malfunction has allowed DePuy to sell 93,000 hip replacements worldwide unregulated. Consequently, the DePuy hip recall has caused deleterious effects to thousands of recipients. In addition to that, DePuy is also under fire because of the alleged ‘kickback scandal’ reporting of the company paying consultants to make them use its products exclusively.
  • 3. Australia and the United Kingdom were able to immediately detect the presence of defective hip implants because they were fortunate enough to have artificial joint registries in place. As early as 2007, the National Joint Replacement Registry in Australia reported higher than normal failure rates of the DePuy hip replacements. By 2009, DePuy voluntarily withdrew its products from the market. In a similar situation, the National Joint Registry of England and Wales was also prompt in discovering defective hip replacements. A study performed by English researchers at Oxford University showed that 3.4 percent of patients out of 660 who received DePuy metal hip implants experienced signs and symptoms associated with metallosis. Comparatively, the studies also showed that 155 patients who received a competing manufacturer’s hip implants were examined and did not exhibit any similar side effects.
  • 4. Around the same time, the U.S. Food and Drug Administration received several hundreds of complaints regarding metal-on-metal implants, but took no action due to the lack of a regulatory national registry. Although many surgeons have stepped forward, claiming that they immediately alerted DePuy about complications from their defective hip implants, their claims were met with little to no response. The public was not aware about the seriousness of this issue until the media began reporting about DePuy’s higher than normal failure rates in 2010. Public outcry in 2010 from media reports about the high failure rates of the DePuy implants along with pressure from the FDA finally forced DePuy to initiate a recall in August of 2010.
  • 5. The orthopedic manufacturer knew of its defective products and avoided initiating a DePuy hip replacement recall .It has shown a blatant disregard for the health and safety of its consumers.