Registries (ICOR) to create uniformity of data collection, enhance sharing
of data, and to create a universal bar code for implants. Despite Mr.
Charnley’s primacy in inventing joint replacement, England only created a
national joint registry in 2002. Amazingly, the United States still has no
national registry. John Callaghan, MD, a renowned orthopedic surgeon
from Iowa, has stated, “We are No. 1 both as a provider and user of
implants. We should be the leader in the follow-up of them.”^20
Surgeons in Australia began implanting the ASR hip in 2004; by 2007
the Australian National Joint Replacement Registry (ANJRR) reported that
the DePuy implant had a higher than expected revision rate. Governing
bodies have concluded that hip prostheses are expected to fail less than 1
percent per year, meaning that five years from implantation, 95 percent of
patients should still have a well-functioning hip in place. However, the
Australian data showed a 5.16 percent revision rate at two years,^21 a
startling pace for an implant that was supposed to be the solution for
younger patients who needed a particularly robust hip. Professor Steven
Graves, director of the ANJRR, notified DePuy of the sobering news,
calling it an “unambiguous end point—nobody can argue about it.”^22 But
as Deborah Cohen points out,^23 that’s exactly what DePuy did for the next
several years, despite mounting evidence that the ASR was a ticking time
bomb.
What does it mean for an implant to fail? When a pacemaker fails
(electronic misfire, battery failure, or wire breakage, for example), the
results can be immediately lethal. If an implant has not been properly
sterilized or the packaging has been compromised, a patient can succumb
to an infection. But in the case of the ASR hip, the failure of the implant
meant that patients were exposed to the particles of metal scrapings that
were generated from the flawed design or implantation of the components.
The microscopic molecules incited the membranes around the implanted
metal components to inflame, creating swollen, irritated cyst pockets that
eventually led to destruction of the muscles, tendons, ligaments, and bones
around the hip. Patients who trusted their surgeons to take away their
arthritic hip pain were sometimes damned to experience even worse pain
than they started with. A failed hip, therefore, necessitates even more
complex hip surgery, demanding the surgeon take out the flawed implants,
and then implant revision components that (hopefully) can find firm
foundation in the remaining bone. Every patient who has undergone more