http://www.hiprecalllaw.com/updates/fda-proposes-new-rule-to-create-medical-device-identification-tracking-system/ -The FDA was alarmed at the increasing failure rates of hip replacement items, specifically those that were entirely made out of metals, the New York Times report, further detailing the agency’s plan to enforce the use of a medical device identification system.

2. The FDA was alarmed at the increasing failure
rates of hip replacement items, specifically those
that were entirely made out of metals, the New
York Times report, further detailing the agency’s
plan to enforce the
use of a medical device identification system. This
tool will carry information about the device and its
manufacturing details, keeping the patient’s
medical information protected.

3. This resulted from the collaboration of involved
patients and their supporters, advocacy groups,
medical device manufacturers, and the US
regulators. Metal-on-metal hip implants were
indiscriminately prescribed by orthopedic
surgeons to most of their patients that require
hip repairs and replacements after its
introduction in the medical market.

4. Adverse events, however, followed in a short span of
time after most of the performed hip replacement
surgeries that amounted to over 500,000 cases. As the
metal wears out, some metallic debris may slough off
the device causing infections and damage to certain
muscles and tissues. When it leaks into the bloodstream
and reaches the heart or the brain, other more serious
health issues may result.

5. Other more common adverse events that may
follow a hip replacement procedure include
implant loosening or dislocations. Fractures of
the bone surrounding the implant may also
occur. These trigger physical discomforts which
may include pain (of the hip or the pelvic area),
inflammation, restricted mobility of the lower
extremities, and a possible increase in bone
resorption.

6. Before these medical implants were marketed,
they never had to undergo certain clinical trials.
The federal agency also did not require medical
device providers to watch over patient’s
conditions following surgeries. For this reason,
doctors believed these products are safe to use.
Mostly, because of the products’ sturdier
material when compared to other existing
implantable hip devices, orthopedists
immediately concluded these are better
replacements for diseases or fractured hips.

7. Five metal hip device manufacturers were
ordered by the Food and Drug Administration to
evaluate patients who have received their
implants. So far, only Biomet has submitted an
acceptable study plan which the FDA
immediately approved. However, it was already
ten years (since the first production of these
items) that attempts to strategize a clinical study
of the implants were initiated. Some experts
believe this might be too late to gather some
pertinent data.

8. Depuy, one top provider of metal hip
replacements, has somehow managed to keep
track of the clinical data from two of their
manufactured implants (ASR and Pinnacle). The
study started in 2006 and involved 250 patients
across the country. This may be very useful
especially to those who are looking for more
information regarding hip recall law.

9. Source:
http://williamdavis101.wordpress.com/2012/07
/10/adverse-events-related-to-hip-implants-
alerted-the-fda/
References:
nytimes.com/2012/06/27/health/replacement-
hips-focus-of-fda-hearing.html?_r=1
global.christianpost.com/news/metal-hip-
replacements-could-cause-chronic-pain-
should-be-avoided-77480/
da.gov/AdvisoryCommittees/Calendar/ucm2978
84.htm