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The history, development, design,
and current health concerns of
metal-on-metal hip implants
&
Courts, trials, verdicts and
settlements
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Metal-on-Metal
DePuy ASR
 DePuy Pinnacle
 Wright Dynasty
 Wright Conserve
 Biomet Magnum
38 & M2a
 Zimmer Durom Cup
 Smith & Nephew R3
Failed Metal
Taper/Stem
Systems

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Wright Profemur
 Stryker Rejuvenate
 Stryker ABG II
 Stryker Accolade

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
Arthritis

Trauma

Avascular necrosis

Damaged or diseased bone in hip joint

Help the joint work better

Improve walking

Relieve pain
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Starting in 1880, doctors attempted to create
hip implants but were unsuccessful
 1950’s: McKee from Britain, and later Herbert
from France, first generation metal on metal
bearing used; mostly abandoned due to
excessive wear and metal particles release
causing metallosis
 Dr. John Charnley, a renowned British
orthopedic surgeon, created the first successful
series of implantations of the total hip
prosthesis in 1962

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 The
initial prosthesis consisted of a teflon
acetabular cup, later replaced by highdensity polyethylene and a stainless steel
monoblock femoral component
 The
Charnley prosthesis was the most
successful and became a “gold standard” for
hip replacement (still used in modified
versions)
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
Total Hip Replacements “THR”
 First generation:
 1970’s
 high failure rate
 Second generation:
 1980’s to present- 1% per year failure
 Stainless steel, nickel, cobalt/chromium,
titanium
 2006: Resurfacing Implant (does not have
femoral ball/neck)
 FDA approval: Premarket Approval (PMA)
or 510k “substantial equivalence”
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 Medical
device companies claimed they
would last longer than polyethylene and
ceramic
 Larger
size would reduce dislocations
 Younger,
more active populations
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 Pain
in the buttock, groin, and/or thigh
 Elevated levels of cobalt or chromium in the
blood
 Soft tissue studies (Sonogram or MRI)
showing fluid, pseudotumor, or infection
 Squeaking
 Dislocation
of the hip
 X-Rays showing loose hardware
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 Pre




2012 used:
0 to 5 ug/L= “normal”
5 to 10 ug/L= concern
10 to 15 ug/L= consider revision + post-revision tests
Some patients in the 100+ range!
 Post
2012: doctors concerned about even
lower levels when associated with pain,
abnormal x-rays, or abnormal
scans/sonograms
 Urine
tests also available
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 Tissue
damage
 Infection
 Cardiomyopathy
 Neurological symptoms
 Hearing, eyesight
 Chromium known to be genotoxic since
1890 (not a typo!)
 Potential for cancer due to cellular DNA
mutations
 No device companies monitored this
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 FDA
issues 145 orders for post-market
surveillance studies to 21 manufacturers
of metal-on-metal hip systems
 Manufacturers
were required to submit a
study plan to the FDA that addressed
specific safety issues related to these
devices
 Must
include failure rates of implants
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 FDA
asks panel to suggest how to study
this problem, leading industry experts
discuss safety and effectiveness of M-o-M
hips, issues long report
 Patients
express concern
 Panel’s
chair tells media he would not use
these in his practice going anymore because
he sees too many risks and no benefit
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
New “Proposed Order”

Change 510k to premarket approval

Comments submitted through April 18, 2013

Final order to be issued

90 days after order, becomes a PMA device and
will most likely permanently end sales
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Do testing to determine if there is:
– adverse local tissue reaction “ALTR”
– adverse reaction to metal debris “ARMD”
 X-ray, scans, soft tissue sonograms
 Blood tests for cobalt and chromium
 Special attention: bilateral, females, bad
alignment, overweight, high level physical
activity

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 Sulzer
hip implant
2002
– Recalled in 2000 for machinery oil on
hardware
–
 Stryker
Trilogy (Pre-Market Approval)
2008
– Ceramic on ceramic squeaking
–
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 MDL
in Newark, NJ: Judge Arleo – most
cases already settled through mediation
 July
22, 2008: recall for loosening
acetabular cups (new implanting
instructions)
 Cup
rim design prevents bony in-growth
 Now
seeing metallosis cases
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 Leon
Kransky,65 y.o., trial in Los Angeles.
DePuy ASR implanted in 2007, revised
2012. “Preference” trial due to cancer
 March
2013 verdict for revision patient
 $330,000
for medical bills and expenses
 $8
million for past and future pain and
suffering . No punitive damages.
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 Illinois

First Illinois state trial (more to come)
 Cook County, Judge Dooling
 54
year old nurse implanted with ASR in
2008, revision in 2011
 DePuy
used “individual biology” defense:
 many pre-existing problems
 implanting surgeon is one who decides
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 Faye
Dorney-Magditz, in her 50’s
 2009
insertion - “late insertion”- Punitive
damages?
 Revision
 Doing
due to pain and high metal levels
well after revision
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 Decision
made with surgeon
 Replace
one or more of the following: stem,
ball, neck
 Remove
scar tissue, excess fluid, dead
tissue, metal shreds
 If
infection, place antibiotic spacer for 6
weeks
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 Hospital
to retain hardware? Patient?
Litigation depository?
 Photographs
 Pathology
taken by surgeon
specimens
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 Approximately
10% of revision surgeries
have some type of complication requiring
further surgery within 1 year
 Infection
 Dislocations (poor muscle strength)
 Only minor relief of pain due to very
compromised bone or soft tissue
 Significant movement limitations
 Stress on back, hips, knees, feet
 Hip implant longevity decreases
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 Have
you had an implant revision?
 Reason for revision: failure due to defect?
 Can you identify the manufacturer of the
implant?
 Pain & suffering- past/future
 Permanent disability
 Loss of income
 Time limits to file suit – NY 3 years
 Best court for you
 Not suing doctors
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 Past
pain and suffering
 Future pain and suffering
 Unpaid past/future medical bills
 Past/future lost earnings
 Lost earning capacity
 “Out of pocket” expenses
 Lost retirement benefits
 Punitive damages (…threat of…)
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 Private
company hired by DePuy and
Stryker
 Allegedly provides reimbursement for
medical bills, lost income, associated “out of
pocket” expenses
 Obtains complete access to your medical
records
 Close relationship with some orthopedic
surgeons
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 Our
implants may have had some problems,
but not in your case
 Surgeon
 You
did not implant it correctly
weren’t a proper candidate
 Your
“individual biology” does not make you
a good implant candidate (but never told
doctors that!)
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 You
did not have any complaints until you
heard of the recall or saw an attorney ad
 There
is no microscopic evidence of
abnormal wear on the removed hardware
 You
don’t have the removed hardware and
can’t support your failure allegations
 The
revision surgeon did not mention any
metallosis conditions in the surgical report
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 Your
implant was put in before we knew
about the problems
 You
waited too long to file suit (statue of
limitations)
 Your
implant failure was caused by the preexisting medical conditions you have
 Your
surgeon won’t say there was a problem
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design: all matching
cobalt/chromium cup/stem/ball
 “Monoblock”
 Large
 Poor
size options
rim design, shallow cup
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 2007
“smoking gun” PowerPoint
 2008-2009
DePuy internally decides to
phase out ASR line while still promoting
sales and defending failures – blames
doctors
 2009
DePuy voluntarily recalls ASR in
Australia
 August
2010 worldwide voluntary recall
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 Scientific
–
–
–
literature:
At recall (August 2010): Data showed eight to
twelve percent increased risk of revisions
within five years
July 2011: Data shows 25% increased risk of
failure in the ASR resurfacing hip and 49%
increased risk of failure in the ASR THR
within six years
Australian Implant Registry 2012 data
expects 44% revision rate at 7 years
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 Federal
court multidistrict litigation (MDL)
– Judge David R. Katz, N.D. Ohio
– Trials set in Fall 2013
 California
and Illinois state court
consolidated litigation
 New
Jersey state court consolidated
litigation: Judge Martinotti, Bergen Co., NJ
— Trials set in September and November
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 Modular
hip replacement
– Outer shell
– Inner liner
– Femoral head
– Femoral stem
– Screws
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 Ultamet
 AltrX
(metal)
(polyethylene)
 Marathon
(polyethylene)
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 MDL:
Northern District of Texas
– Over 2,500 cases filed in MDL :September
1, 2014 first trial
 California
consolidated litigation
 In
May 2013 DePuy announces that the Mo-M Pinnacle line will be discontinued
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 Conserve
Total Hip System
 Conserve Plus Total Resurfacing Hip
System
 Lineage Acetabular Cup System
 Dynasty Acetabular Cup System
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 Catastrophic
failure of the implant
 Modular neck fractures involve defects and
injuries that are distinct
 Stem is often paired with a Conserve or
Dynasty acetabular cup
 Cases involving modular neck fractures are
excluded from both federal and California
coordinated proceedings
 Must litigate with individual suit
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 MDL:
Atlanta, Georgia
 Judge
William S. Duffey, Jr.
 Metal-on-metal
cases related to Conserve
product line only
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 In
re Wright Hip Sys. Cases, JCCP 4710,
Super. Ct. Cal., L.A.
 Judge
Jane L. Johnson
 All
Wright metal-on-metal hip implants
including those from the Conserve,
Dynasty, and Lineage product lines
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
Manufactured by Howmedica in Mawah, NJ

Modular design promoted as non metal-onmetal after ASR recall

Titanium stem

Cobalt/chromium neck

Polyethylene ball

Metal cup
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 Canadian
–
–
May 28, 2012
Rejuvenate only, not ABG II
 American
–
–
recall
recall
July 4, 2012
No plan to pay for revision surgeries
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 Consolidated
litigation: Judge Martinotti,
Bergen Co., NJ
 Exploring
possible mediation program
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 Consolidated
litigation: Judge Miller,
Northern District of Indiana, MDL 2391
 No
trial dates set – maybe 2015
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