Kransky vDePuy Orthopaedics

1
2
 Ex. 1024
3

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 September9,2011

KaplanMeier
ClinicalStudy

Ex. 594
4

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
DePuy ASRDesignTeamSurgeons
(RoyaltyBased)

Thomas Schmalzreid, M.D. Thomas Parker Vail, M.D.

Joint Replacement Institute UCSF Medical Center
Los Angeles, CA San Francisco CA

5
TotalHipReplacement

6
PinnacleModular ASRMonoblock

7
 TheASRXL Monoblock System

Unlike any other

hip implant
Unique design
features
Never tested in
people

8
 ASRXLNewand
UniqueDesignFeatures

Metal Head - Metal Cup (CoCr M-O-M )

1 piece cup
not modular - no liner, no screw holes
Internal groove
reduces amount of bearing surface
Sub hemispheric cup
exterior less than 180 degrees

9
 ArtificialHipMustBeDesigned
ToEnsureItLastsAsLongAsPossible

10
ASRIntroducer

11
 AllHipImplants
NationalJointRegistryofEnglandandWales 2012AnnualReport

5YearsAfterImplant
Failed
2.61%

NotFailed
97.39%

12
 AllHipImplants ASRHipImplant
NationalJointRegistryofEnglandandWales NationalJointRegistryofEnglandandWales
2012AnnualReport 2012AnnualReport

5YearsAfterImplant 5YearsAfterImplant

Failed
2.61%

Not Not Failed

Failed 21.93%
Failed
97.39% 78.7%

13
 AllHipImplants ASRHipImplant
NationalJointRegistryofEnglandandWales DePuys InternalData
2012AnnualReport

5YearsAfterImplant 4.57YearsAfterImplant

Failed
2.61%
Not
Not Failed
Failed 63%
Failed
97.39% 37%

14
 AllHipImplants ASRHipImplant
NationalJointRegistryofEnglandandWales NationalJointRegistryofAustralia
2012AnnualReport 2012AnnualReport

5YearsAfterImplant 7YearsAfterImplant

Failed
2.61%
Not
Failed
Not 56%
Failed
97.39% Failed
44%

15
JobQualifications
MagnusFlett

Deposition of Magnus Flett- Page:Line 479:3480:19

16
TheImportanceofClinicalTesting
GrahamIsaac

Deposition of Graham Isaac - Page:Line 550:11-551:3

17
 January25,2005
February10,2005

Ex. 748
18

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 June10,2005

Ex. 629
19

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 October11,2005

Ex. 831
20

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 UnitedStatesLaunch
2006

Ex. 620
21

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 UnitedStatesLaunch
2006

Reducingthewearrateof
ahipbearingcanimprove
longtermfunction.By
maintainingoptimal
clearancebetweenalarge
diameterheadandthecup,
theASRXLbearings
produceafluidfilm
interfacethatresultsina
lowerwearratethan
previouslyachievedin
metalonmetal
articulation.
Ex. 620
22

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 UnitedStatesLaunch
2006

Bearingsurfacesarefully
separatedandtheload
fullysupportedbythe
lubricatingfluid.

Ex. 620
23

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 June28,2006

Ex. 1048
24

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 May14,2007

Ex. 1133
25

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 June6,2007

Ex. 625
26

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 June26,2007

Ex. 731
27

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 September27,2007

Page1 Ex. 833

28

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 September27,2007

Page2 Ex. 833

29

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 September27,2007

Page17 Ex. 833

30

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 October8,2007

Ex. 1010
31

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 January5,2007

Page 7 of 12

Ex. 1062
32

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 2008

Page1 Page16

Page16
Metallosis
Ex. 1178
33

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 April30,2008

Ex. 608
34

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 May2,2008

Ex. 608
35

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 May8,2008

Ex. 443
36

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 June24,2008

Ex. 458
37

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 July2,2008

Ex. 1081
38

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 August15,2008

Ex. 433
39

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 August23,2008

Ex. 532
ASP=AverageSalesPrice Page3
40

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 November7,2008

Ex. 884
41

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 December,2008

Ex. 920
42

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 December18,2008

Ex. 1056
43

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 December19,2008

Ex. 687
44

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 March16,2009

Ex. 904
45

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 March16,2009

Ex. 916
46

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 September17,2009

Ex. 753
47

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 September17,2009

Ex. 753
48

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 May4,2010

Ex. 561
49

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 August24,2010

Ex. 1021 50

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
LorenBillKransky

Date of birth: 10/27/47

66 years old
Husband and father of
two daughters
Served our country in
the Vietnam War and
in the U.S. Air Force
Retired in 2006

51
52
 Mr.Kranskys ASRXLHistory

ASR XL
removed
ASR XL and
implanted RECALL rehabilitation
12/5/07 8/24/10 2/20/12 4/12

2007 2008 2009 2010 2011 2012

50months:over4years
53
 DefendantResponsestoSpecialInterrogatories
Mr.Kranskys DoctorsDidNothingWrong

54

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 OtherHealthIssues
WhileMr.Kransky HadtheASRXL
January 2009 Right nephrectomy
May 2009 Completed four cycles of chemotherapy
August 2010 Radiation treatment at Mayo Clinic
October 2010 Received additional chemotherapy treatment
April 2011 Repair abdominal aortic aneurysm
July 2011 Left renal artery stenting
August 2011 Right hemispheric stroke

55

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 DefendantResponsestoSpecialInterrogatories

Mr.Kransky DidNotCauseHisInjuries

56

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 DefendantResponsestoSpecialInterrogatories

DefendantsAgreeMr.Kransky WasaProper
PatientfortheASRXL

57

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 PostASRXLHipImplantComplaints
Dec.5,2007 Dr. Wendt performs hip replacement surgery on Mr. Kransky implants ASR XL

May2,2008 Mr. Kransky sees primary care physician, Thomas Trotsky, M.D. - left hip pain

Oct.26,2009 Mr. Kransky sees Dr. Trotsky - left hip pain mostly at night and
sometimes when walking

Nov.27,2009 Mr. Kransky sees Dr. Trotsky - legs giving way when walking

Jan.27,2011 Mr. Kransky sees Dr. Trotsky - left hip is popping and grinding

Early May,2011 Mr. Kransky sees Dr. Trotsky - falling - has pain in left hip

June15,2011 Mr. Kransky referred to Dr. Daniel Brooke - orthopaedic surgeon

Oct.19,2011 Mr. Kransky sees Jeffrey Hansen, M.D. - orthopaedic surgeon

Jan.23,2012 Mr. Kransky returns to Dr. Hansen pre op evaluation

Feb.20,2012 Mr. Kransky undergoes revision surgery - hospitalized until March 13, 2012

58

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 ThomasTrotsky,M.D.
UnlessASRXLHipWasRemoved,BillWasDying

QuickTime and a
Photo - JPEG decompressor
are needed to see this picture.

Deposition of Dr. Trotsky Page:Line 166:1-14

Thomas Trotsky, M.D. - Bill Kranskys Primary Internal Medicine Doctor 59

 Mr.Kranskys Preoperative
CobaltAndChromiumLevels
Date Chromium Cobalt
9/01/11 24.2ug/L(serum) 53.6ug/L(serumorplasma)
27.5ug/L (serum)
9/19/11 46.2ug/L(serum) 109ug/L(serum)
10/19/11 NoChromiumDraw 47mgc/L(serumorplasma)

Recall notice suggests over 7 ppb is concerning

and should be monitored closely
Current recommendation is to monitor patients
with levels over 2 ppb
60
 Mr.Kransky
RevisionSurgeryFeb20,2012

Ex. 16 61

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 Metallosis

Mr.Kransky
RevisionSurgeryFeb.20,2012
DePuy BrochurePage16
Ex. 1178 Ex. 16

62
 RevisionNotDueToInfection
Pre-op surgical evaluation did not indicate
infection

Prior to surgery, Dr. Hansen did not believe

there was infection

Intra-operative culture Negative

Post operatively Dr. Hansen did not believe

condition caused by infection

Only positive culture was from hematoma that

developed post operatively
63

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
SurgeonDr.Hansen

Deposition of Dr. Hansen Page:Line 331:23-332:17

64
 DefendantResponsestoSpecialInterrogatories

Mr.Kranskys DoctorsTreatedHimAppropriately

65

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
 Dr.DennisBobyn
Masters and Ph.D in Biomaterials and
Biomechanics
Director, Orthopaedic Retrieval and Research
Laboratory, Montreal General Hospital
Has examined explanted hip implants for
more than 30 years
Authored / Co-Authored Peer-Reviewed
Scientific Articles on Metal-on-Metal Hips
Elite Member of Editorial Board, Journal of
Arthroplasty
66
 Dr.BobynsOpinions
The ASR hip implant has design defects that
cause it to fail at a much greater rate than
other hip implants

Any perceived benefits of the ASR were

greatly outweighed by the risks of the implant

Mr. Kranskys ASR XL hip implant was

defective, causing it to fail, shedding
significant amounts of cobalt and chromium
into Mr. Kranskys body
67
Kransky RimMax/Min

1.3

0.8

68
 AllHipImplants ASRHipImplant
NationalJointRegistryofEnglandandWales Dr.PeterWendtsExperience
2012AnnualReport

5YearsAfterImplant

Failed
2.61%

Failed
Not Not 18.4%
Failed Failed
97.39% 81.6%

69
 AllHipImplants ASRHipImplant
NationalJointRegistryofEnglandandWales Dr.CraigSwensens Experience
2012AnnualReport

5YearsAfterImplant

Failed
2.61%

Not
Not Failed
Failed 65% Failed
97.39% 35%

70
 Mr.Kranskys ASRXLHistory

ASR XL
removed
ASR XL and
implanted RECALL rehabilitation
12/5/07 8/24/10 2/20/12 4/12

2007 2008 2009 2010 2011 2012

50months:over4years
71
72