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AID,INC Selling Guide

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Integrity Selling Material

PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER. DEPUY019393887

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3 | For internal use only. All outside distribution is prohibited.

Table of Contents

Page 4 Integrity Guide Overview

Page 5 The APPROACH

Page 6 Approach by Behavior Style

Page 8 The INTERVIEW

Page 9 Current Situation Questions

Page 14 Desired Situation Questions

Page 16 Benefit / Reward Questions

Page 18 Risk / Consequence Questions

Page 20 Urgency / Importance Questions

Page 21 The DEMONSTRATION

Page 22 The VALIDATION

· Metal

· Polyethylene

· Ceramic

· Quick Source Reference Table

Page 27 The NEGOTIATION

· Negotiate the Pinnacle Acetabular System

· Negotiate Polyethylene

· Negotiate BIOLOX delta

· Negotiate Stability & Range of Motion

· Negotiate Metal Wear

· Negotiate aSphere

· Negotiate Ions

· Ions for Dummies

Page 43 References

Page 44 The CLOSE


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Leading Change in a New Environment

To help you with the entire Integrity™ Selling process, tools have been created for each step of

AID,INC. This guide was specifically designed to assist you in customizing your pre-call plan.

Please find the following resources in this Integrity reference:

· Approach section – Tips for a successful approach, as well as examples of approaches for each behavior style

· Interview section – The GAP model and a question library broken down by each type of GAP question, as well as by negotiation topics to allow you to effectively create your Pinnacle pre-call plan

· Demonstrate & Validate sections – Key Pinnacle literature you can use during HCP sales calls to discuss our offerings, advanced materials, and clinical evidence

· Negotiate section – Created to assist you in understanding the needs Pinnacle Hip Solutions can fulfill, the science and data behind each bearing, and conversational examples of ways to handle common objections

· Close section – Tips for a successful close, including examples of “Trial-Close” questions

Approach Interview

Listen

Talk

Practicing AID, Inc. is simply having an organized conversation with customers.Integrity Selling®, AID INC® are trademarks owned by Integrity Solutions, Inc.1

A I D I N C®

Demonstrate Validate Negotiate Close

Time

Approach Interview

Listen

Talk

Practicing AID, Inc. is simply having an organized conversation with customers.Integrity Selling®, AID INC® are trademarks owned by Integrity Solutions, Inc.1

A I D I N C®

Demonstrate Validate Negotiate Close

Time


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APPROACH

Purpose: To Gain Trust and Rapport

and to show appreciation to build trust

Tools: Use your body language and physical appearance to make a positive first impression

APPROACH TIP 1: The HCP should do most of the talking during the Approach phase

APPROACH TIP 2: behaviors to make your HCP most comfortable during conversations

APPROACH TIP 3: Ask questions using behaviors that

APPROACH TIP 4: Remember to ask about personal or work discussions the HCP shares as an opportunity to re-connect in future conversations


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APPROACHES by Behavior Style

Doer: Impatient and driven; pressed for time; result-oriented; bottom line; lower need for establishing relationships.

Approaching Doers:

time for one quick question.

Controller: Lower energy level; detail-oriented; relies on facts, evidence, and data; hesitant to try new products.

Approaching Controllers:

your decisions. May I ask you a few questions on how you make your decisions with regards to your total

get time, I would be interested in your analysis of technologies within total knee replacement. Would you


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Supporter: Cooperative and attentive; wants accurate information before making decision; trusting relationships.

Approaching Supporters:

in medicine was because you really do care about people and truly want to help them.

do whatever I can when those situations come up. I like when I can count on people and I want to be

Talker: Outgoing, enthusiastic, approachable and people-oriented; less interested in details; prefer collaboration.

Approaching Talkers:


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Identify Needs and Problems

Logical

Emotional

GAP

Current Situation

Risks/Consequences

DesiredSituation

Benefits/Rewards

Urgency/Importance

Your solutions are the vehicles that moveHCPs from current to desired situation

INTERVIEW


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patient types.

their options, what are patients saying now about

able to wait to hear how things ended up with ___.

times to obtain the ideal inclination or version intra-

Which of your patients get the most benefit from

Past / Current Behaviors, Concerns & Patient Types

Talkers Supporters Doers ControllersKEY

Current Situation Questions

Desired Situation Questions

Questions

Questions

Questions

Pre-Call Planning GAP Questions Library (see the Integrity Reference for GAP Question definitions)


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What type of information have you required in the

How do you select a safe and effective bearing for

What was your take on the analysis and results of

What forms of data are critical when choosing a THA

What types of research or clinical studies do you like

desires for treatments when it conflicts with the best

selection based on the changing demands of

Can you tell me which forms of data are most

Decision Making

Preferred Information




Questions

Questions

Questions


INTERVIEW


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MoM products.

What is the bottom line for you when it comes to

Please distill down for me the benefits you see in using a MoM construct vs. metal-on-poly.

What is the algorithm you use for selecting bearings

Alternative Bearings Experiences /Beliefs



Questions

Questions

Questions




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What percentage of your THA patients receive metal

What is your analysis of the numerous MoM articles

monoblock or resurfacing systems and where do you

Polyethylene

Metal Liners & Heads



Questions

Questions

Questions



INTERVIEW


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IF YES - Was it with the previous ceramic material, forte, or the newest generation

delta

a metal head vs. ceramic head for your total hip

Ceramic Materials

Economic Buyer



Questions

Questions

Questions




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your patients from hip replacement.

for your THAs.

What data or clinical studies would you like to have that

What risks that, if you could minimize them, would make

What outcomes would you like to achieve for your patients

What obstacles do you have today that you would like to

could help you.

would like to improve upon.

would be for an implant surface.

General Desires



Questions

Questions

Questions



INTERVIEW


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receive from a bearing that offers low wear.

many are researching their surgical options on the

low wearing bearing.

elevated metal ions in MoM hip implants.

Bearing Desires

Economic Buyer Desires



Questions

Questions

Questions




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Would things be simpler for your staff if that

flexibility would help you.

low wear with intra-operative modularity, what

mentioned could impact you.

that adjustment could be achieved.

you described, how would that impact your day-to-

impacts you and your patients.

with a larger head-to-shell ratio compared to your

option in your practice, how could that enhance your

General Benefits (following up on specific desires)

THA Benefits



Questions

Questions

Questions



INTERVIEW


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it significantly lowered the wear generated, how

alleviated by using a lower wearing bearing.

Bearing Benefits

Economic Buyer Benefits



Questions

Questions

Questions




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What could happen if a patient needs to have your

friction fit acetabular cup like the one in the _____

regimen result in sub-optimal outcomes in this new

What happens if you have a failure from a clinically

What is the bottom line for you if you stayed with

Distill down for me the benefits you see in using a MoM construct vs. MoP, please.

going forward.

significant enough for you to consider making a

General Risks



Questions

Questions

Questions



INTERVIEW


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a hard bearing that does not obtain fluid film

Bearing Risks

Economic Buyer Risks



Questions

Questions

Questions



For Stryker X3


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Questions

Questions

Questions




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In future product launches, new HCP and Sales Associate literature will be created specifically to aid

literature piece to use when having general HCP discussions about the entire Pinnacle portfolio.

DESIGN RATIONALE

PINN

AC

LE® H

IP SOLU

TION

S

The Pinnacle Brochure has clearly marked tabs for discussing the following topics with an HCP:

™

™ over Marathon™ LD in stability and

jump distances® and

Ultamet®

® delta®, Gription®,

and DuoFix® coatings

Femoral Solutions, DePuy Institute and a listing of our Design Surgeons Pinnacle Brochure - Cat. No. 0612-69-507

DEMONSTRATION


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The tools used to Validate our products are the specific and detailed HCP literature pieces, such as Surgical Techniques, Design Rationales, White Papers, Peer-reviewed Journal Articles, Clinical Compendiums, as well as DVDs created for surgeons

The following pages contain examples of valuable Pinnacle validation literature.

Design Rationale

0612-20-508

0612-95-505Charles A Engh, Jr., MD; Steven J MacDonald, MD; Supatra Sritulanondha, MPH; Abigail; Thompson,

RN; Douglas Naudie, MD; Charles A Engh, Sr., MD, A comparison of three total hip arthroplasty

bearing surfaces: a randomized trial. Clin Orthopaedics and Related Research (In Press, 2008)

Dowson D, Hardaker C, Flett M, Isaac GH. “A Hip Joint Simulator Study of the

Performance of Metal-on-Metal Joints. Part I: The Role of Materials.” J Arthroplasty.

2004;19(8, suppl 3):118-123.

Dowson D, Hardaker C, Flett M, Isaac GH. “A Hip Joint Simulator Study of the Performance of Metal-on-Metal Joints. Part II: Design.” J Arthroplasty. 2004;19(8, suppl 3):124-130.

Bergman G, Deuretzbacher G, Heller M, et al. “Hip Contact Forces and Gait

Patterns from Routine Activities.” J Biomech. 2001;34(7):859-871.

0612-21-508 0612-72-509

Metal

Survivorship of the Pinnacle® Acetabular Cup System

Pamela L. Plouhar, Ph.D., Vice President Worldwide Clinical Affairs†; Rodrigo Diaz, MD, Manager, Clinical Research†;

Gary Warriner, MSc, Senior Biostatistician†; Kristine Lee, MPM, Senior Technical Writer†

Many factors affect hip survival, including bearing type, material properties, component design, head size, implant alignment, restoration of joint me-

chanics, and patient characteristics such as skeletal morphology, muscle function, and tissue laxity. Some hip systems have a long clinical history, making

it possible to determine the effect that these variables have on device safety and performance. Newer systems with less clinical history include current

generation modular and monoblock metal-on-metal, ceramic, and highly cross-linked polyethylene hip systems. The impact and relative importance of

variables that affect implant survival in these newer systems is emerging. National joint registries and large databases provide valuable information on the

revision rates/survivorship of newer and older implants alike. The data contained within various registries and large databases vary in terms of patient,

surgeon, and institutional specificity. The value of most registries is that they include large cohorts with contributions from all surgeons, irrespective of

experience level. The limitation of registry data is the lack of patient-level detail that might reflect selection, complexity, or comorbidity, and information

on surgeon experience. Examples of these data sources include the Australian Orthopaedic Registry (AOA), the Swedish Registry, and the National Joint

Registry (NJR) for England and Wales.

Typically, a variety of hip systems may be combined into a single broad category (hip replacement) for evaluation in a registry report. Primary total hip

replacement is a well established and efficacious procedure, as demonstrated by the revision rates reported in the National Joint Registry (NJR) for England

and Wales and the Australian Orthopaedic Registry (AOA). The 2009 NJR registry annual report noted a three-year revision rate of 2.6% (95% CI 2.4%-

2.8%) for cementless stems.1 The AOA 2009 annual report noted the yearly cumulative percent revision of primary conventional total hip replacement

(with a primary diagnosis of osteoarthritis, excluding infection) to be 2.8% (2.7, 2.9) at 5 years.2

To evaluate the effect of different variables on device performance, it is possible to look at data available for specific product configurations. Such configura-

tions include bearing materials, head size, and stem-cup combinations.

Effect of Bearing Articulations on Survivorship

The 6th annual report of the National Joint Registry (NJR) for England and Wales, released in 2009, reports results for the following bearing surface

articulations with femoral heads ≤ 32 mm (excluding resurfacing components):1

Three-Year Revision Rate by Bearing Articulation – 2009 National Joint Registry (NJR) for England and Wales

Metal on

Polyethylene

Ceramic on

PolyethyleneCeramic on Ceramic

Metal on Metal

Revision rate (95% CI)1.6% (1.5-1.7%) 1.7% (1.5-2.0%) 2.2% (1.8-2.6%) 1.9% (1.2-3.0%)

Hazard ratio adjusted for age,

gender and physical status1.0 0.8 (0.7-1.0) 0.9 (0.8-1.1) 0.8 (0.5-1.3)

While not statistically significant, it is important to note that the risk of revision (as reflected in the “hazard ratio”) for metal-on-metal articulations was

less at three years postoperatively compared to metal-on-polyethylene articulations, after adjusting for age, gender, and physical activity.

Clinical Data on the Pinnacle® Acetabular Cup System

The Pinnacle Acetabular Cup System performed as well or better than other hip systems based on the yearly cumulative revision rates (which ranged from

1.6 to 6.8 revisions at 5 years) seen in the 2009 Australian Orthopaedic Registry Annual Report (AOA).2 This registry report is consistent with a 5-year

survivorship of 99.9% reported in a clinical study conducted by Kindsfater et al. of 1,183 subjects. In this study 2% of bearings were ceramic on polyeth-

ylene; 35% were metal-on-metal bearings (MoM); and 63% were metal-on-polyethylene bearings.3

Pinnacle Acetabular Cup System – Various Bearing Combinations using Corail®, Summit®, and S-ROM® Hip Stems

2009 Australian Orthopaedic Registry (AOA)

Corail Hip System Summit Hip System S-ROM Modular Hip System

Yearly cumulative revision rates2.6% at 5 years 1.6% at 5 years 3.7% at 5 years

In March 2010, using information from the National Joint Registry (NJR) for England and Wales, a Kaplan Meier survivorship analysis was conducted on

11,471 primary Pinnacle Acetabular Cups. This analysis examined the survivorship of metal-on-metal (MoM) bearings with Corail, Summit, and S-ROM

hip stems. Subject mean age was 66 years (range 17-97).4

Pinnacle Acetabular Cup System – MoM Survivorship with Revision for Any Reason as the Endpoint

2009 National Joint Registry (NJR) for England and Wales

1 Year 2 Years 3 Years 4 Years 5 Years 6 Years

MoM Survivorship 99.1% 98.5% 98.0% 97.5% 96.8% 96.4%

Femoral head size has also been shown to impact survivorship.3 Accordingly, NJR data specific to 28, 36, and 40 mm femoral heads using the Pinnacle

Acetabular Cup System with a metal-on-metal (MoM) articulation was also analyzed. The Corail, Summit and S-ROM hip stems were all included in the

Kaplan Meier survivorship analysis.4

Comparison of Median

Serum Cobalt Levels

Median μg/L1 In-Vivo Year

Ultamet® 12 0.73 2

Metasul® 2,8 1.1 1

Ultima® 5,11 1.3 1.6

Sikomet-SM21® 3,9 1.5 1

M2A™ 4,10 1.55 5

Birmingham™ 6,11 2.1 1.3

Cormet® 7,11 3.0 1.3

References1. Sample Method : Serum except Sikomet-SM21 (Whole Blood)

2. METASUL™ is a registered trademark of Zimmer, Inc.

3. Sikomet-SM21is a registered trademark of Sikov Medizintechnik, GmbH.

4. M2A-38 and M2A-Magnum are a trademark of Biomet Orthopaedics, Inc.

5. ULTIMA® and Ultamet® are registered trademarks of Depuy Orthopaedics, Inc.

6. Birmingham is a trademark of Smith & Nephew

7. Cormet is a registered trademark of Corin Group PLC.

8. W. Brodner,et al., Elevated serum cobalt with metal-on-metal articulating surfaces. J Bone Joint Surg Br 79 (1997), p. 316

9. Schaffer et al. Increased blood cobalt and chromium after total hip replacement. J Toxicol 1999

10. Rasquinha, et al. Serum metal levels and bearing surfaces in total hip arthroplasty. J Arthroplasty 21(6 Suppl 2):47-52, 2006

11. M.T. Clarke,et al, Levels of metal ions after small and large-diameter metal-on-metal hip arthroplasty J Bone Joint Surg Br 85 (2003), p. 913

12. C. Anderson Engh Jr., et al. 2008 John Charnley Award ~ Metal ion levels after metal-on-metal total hip arthroplasty: A randomized trial. Clin Orthop Related Res. October 2008

UPDAT

ED

VALIDATION


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Material Rationale

CMC

matrix-compositeceramic

BIOLOX® delta

Advancing High

Stability and Low Wear

A Better Alternative

Today’s high demand patient cohort is frequently unwilling

to give up their vocation or avocation simply because they

have had a hip replacement. A variety of bearing choices

has been developed to address the needs of this popula-

tion. Each has unique advantages as well as disadvan-

tages. Projecting which bearing surface would be best for

a given patient makes decision making difficult for the hip

surgeon of 2007.

Prior to 2007, three classes of bearings were available,

metal on metal, ceramic on ceramic, and metal on plastic.

Metal on metal has outstanding wear characteristics and

the advantage of large head technology to prevent dis-

location. However, concerns over ions prevent universal

adoption. Possible hypersensitivity reactions, specula-

tion over carcinogenic potential, and resistance to using

this bearing in childbearing women or patients with renal

disease may limit its widespread use.

Ceramic on ceramic bearings have the lowest wear in the

laboratory. The wear products released are inert and well

tolerated by patients. However, there may be potential

for fracture with this type of bearing. Revision following

fracture is very difficult as the extremely hard ceramic

particles are difficult to remove and will damage subse-

quent bearings. The squeaking recently associated with

this bearing is another potential problem, which will limit

its use. The cause of squeaking in this bearing is currently

unknown. For surgeons concerned about the fracture risk

in a ceramic on ceramic bearing, the added disadvantage

of squeaking makes this bearing currently unattractive.

Highly cross-linked polyethylene is the third class of

modern bearings. It is a bearing all hip surgeons are very

familiar with. A variety of liner options makes this the most

versatile bearing available. However, the potential for poly-

ethylene-induced osteolysis remains. In addition, the in

vivo wear rates of all cross-linked polyethylenes have not

diminished wear to the extent that was initially predicted in

the laboratory.

From the above discussions one can clearly see why the

hip surgeon of 2007 has difficulty deciding which bearing

is best for their patient. An improved second-generation

cross-linked polyethylene may be an attractive alternative

until a specific bearing system proves superior. Until then

an improved second generation cross-linked poly (AltrX™)

may be the best option for the surgeon with concerns

about the ion issues of metal on metal and the squeaking

and fracture issues of ceramic on ceramic.

In my practice, I want a bearing surface that will meet the

demands of my active patients while preserving intraop-

erative versatility to deal with the challenge of stability,

leg length and offset. AltrX altra-linked polyethylene is an

attractive option for me and my patients.

AltrX is a second generation cross-linked poly made from

a different resin than Marathon® cross-linked polyethyl-

ene. A change from 1050 resin to 1020 resin allows higher

radiation doses (7.5 megarads) to be used. This leads

to greater cross-linking, further reduction in free radicals,

and improved wear. Despite the use of higher radiation,

mechanical integrity similar to a well-established product

such as Marathon® is maintained3. This is accomplished

by placing ram-extruded polyethylene bars made from

1020 resin in a foil package to prevent oxygen exposure.

This bar is then irradiated with 7.5 megarads. The bars

are then remelted in an Argon convection oven and cooled

just below the melting temperature. This controlled ther-

mal environment allows the material to recrystallize which

leads to better mechanical properties. This two-step

remelting and annealing process effectively eliminates free

radicals to a level similar to non-radiated polyethylene3.

Laboratory data has shown a 53% reduction in wear

with AltrX compared to Marathon. This equates to a

92% overall reduction in wear compared to conventional

polyethylene3– a significant improvement that may limit the

prevalence of osteolysis in active patients.

This improvement can be enhanced through the use of

a Delta ceramic head in combination with the AltrX liner.

Delta heads have improved wear characteristics and

greater resistance to third body debris compared to cobalt

chrome heads. Jennings et al. demonstrated 40% less

volumetric wear with ceramic on a cross-linked poly than

those with cobalt chrome heads.1 In addition, McKel-

lop et al. noted better resistance to third body debris for

roughened Delta heads on cross-linked poly – an 82%

reduction compared to roughened cobalt chrome heads.2

My current protocol for hip bearings is

as follows:

I use Delta ceramic on AltrX polyethylene in

my high demand, active patients.

In other patients, I use AltrX with a cobalt

chrome head.

As more information concerning hard bear-

ings is forthcoming, this may cause me to

reevaluate this protocol.

WHY I USE ALTRX™ AS A BEARING SURFACEThomas K. Fehring, MD

Ortho Carolina

Charlotte, NC

DePuy introduced the first FDA-cleared crosslinked

polyethylene, Marathon™, in 1998. Engineered to

balance mechanical and wear properties, Marathon

performs well clinically.5,10 Marathon is produced

from GUR 1050 polyethylene ram extruded bar

that is moderately crosslinked at 5 Mrad of gamma

irradiation. Next, the crosslinked polyethylene bar

is stabilized using a patented remelting process to

eliminate free radicals.

Today’s active patients place high demands on total

hip replacements. These patients require longer life

expectancy from their implants; therefore lower

wear rates are needed.7 Crosslinked polyethylene

provides lower wear rates than conventional (non-

crosslinked) polyethylene, however, according to

some research, the wear particle size in crosslinked

polyethylenes is more biologically active.7 In

an attempt to reduce these biological effects,

particularly with more active patients, several

orthopaedic implant manufacturers have produced

new generations of lower wear crosslinked

polyethylenes. DePuy recently developed a new

polyethylene, AltrX™ to further reduce wear

while maintaining good mechanical integrity and

oxidative resistance. AltrX polyethylene is the result

of substantial scientific research and engineering

development.

Design Rationale

The design goal with AltrX was to lower bearing

wear as much as possible without compromising

mechanical integrity. Marathon uses GUR 1050,

the UHMWPE historically used in hip systems.

Since Marathon has performed well clinically, the

next generation of DePuy crosslinked polyethylene

needed to match or exceed the mechanical properties

AltrX™ AltraLinked Polyethylene

for the Pinnacle Acetabular Cup System

by Mark D. Hanes, Ph.D. – DePuy Orthopaedics, Inc. and Susan G. Capps, Ph.D. – BENSOL | February 2007

of Marathon material. In orthopaedic polyethylene

research and development, it is known that

increasing irradiation levels increases crosslinking

and therefore wear resistance. However, increased

radiation also decreases mechanical properties

such as toughness.3,6,7 Considering the design

goals and the behavior of different polyethylene

materials, DePuy research scientists began the

AltrX development process with an UHMWPE

that offered greater inherent mechanical strength

than GUR 1050 since mechanical strength

degrades after irradiation. GUR 1020, historically

used in knee systems, is inherently stronger than

GUR 1050; therefore, a higher irradiation dose

will cause higher levels of crosslinking and wear

resistance while maintaining the mechanical

strength of Marathon GUR 1050. With an

irradiation dose of 5 Mrad, GUR 1050 and GUR

1020 have similar wear properties but GUR 1020

has superior mechanical properties. Based on these

facts, the question was asked “how high could the

irradiation dose be increased on GUR 1020 and

preserve the advantageous mechanical properties

while improving the wear properties above that of

GUR 1050?” Also, “could the Marathon remelting

process be used to eliminate free radicals in GUR

1020 and therefore produce an oxidatively stable

polyethylene?” These questions were answered

affirmatively during the development of AltrX and

the AltraLink™ Process.

AltraLink™ Process

The AltraLink Process is a unique material

enhancement process that optimizes the balance

between wear resistance, mechanical integrity

and oxidative resistance. It does not create a new

Compatibility Guide

1

INTRODUCTION

As technology and surgical techniques have evolved

since the turn of the millennium, surgeon and

patient expectations have also evolved about implant

durability and expected activity level after total hip

arthroplasty. Traditionally surgeons have had the

onus of selecting the prosthetic joint, but with the

advent of easily obtainable information from multiple

sources, patients have become part of the decision-

making process. The “Millennium Patient”, as coined

by Thomas Schmalzried, MD, is said to be one who

is informed and active, with expanded expectations

about their lifestyle after hip surgery. Although this

may seem daunting, and often times poses challenges

to a surgeon during an office visit, the surgeon should

keep in mind that most patients are only seeking honest

answers from their physician. If a surgeon can take the

time to explain the decision making process in total

hip arthroplasty to their patient, it only strengthens

the doctor-patient relationship. The goal of this paper

is to develop a decision-making framework between

the physician and a patient contemplating THR.

CASE STUDY

S.R. is a 31 year-old female patient that came into the

office complaining of severe and debilitating bilateral

hip pain. Approximately 18 months prior she was

scheduled for an outpatient laparoscopic procedure,

but unfortunately due to complications, had to be

resuscitated in a critical care setting for 4 weeks.

During her course of treatment she received high

doses of corticosteroids. The onset of her pain has been

gradual, but she currently walks with crutches and

takes 4-6 tablets of hydrocodone daily for pain. She is a

kindergarten teacher and is planning on getting married

in 10 months. Her radiographs are Figures 1a, 1b, and 1c.

A Time for Each Bearing,

a Bearing for Each Time

Why polyethylene still matters

Alexander C. Gordon, MD

Assistant Clinical Professor | Illinois Bone and Joint Institute

Department of Orthopaedic Surgery

Flattening of

femoral headCollapse of weight

bearing area

Figure 1a: AP view of both hips demonstrating preserved joint spaces.

Figure 1b : Lateral view of right

hip with crescent signs and subtle

collapse of weight bearing area of

subchondral bone consistent with

post-collapse osteonecrosis.

Figure 1c: Lateral view of left hip

also demonstrating flattening,

consistent with post-collapse

osteonecrosis.

0612-28-500

0612-17-508

0612-77-506

0612-86-505

0612-55-505

0612-92-508

0612-16-507

Polyethylene and Ceramic Introduction:

A single acetabular system

that accommodates a variety of

liner and head size options can

be advantageous in total hip

arthroplasty.

Methods:- 1,183 Primary, Consecutive, Multi-liner,

Acetabular, Pinnacle® Cup THA’s

- Performed Between 2000 & 2006

- 16 Surgeons

- 9 Different Cemented & Uncemented

Stems Implanted

- 463 Left, 546 Right, 87 Bilateral

- Mean Follow-up: 2 Years

- Total Patients: 1,183

- 622 Females & 561 Males

- Mean Age: 62 Years

- Range: 18 to 91

- Mean BMI: 30

- Range: 16 to 65

Results:- At 5 Years, Acetabular Cup

Survival Was 99.9%

- 0% Aseptic Loosening

- 17 Dislocating Hips:

- 76% — 28mm Heads

- 18% — 32mm Heads

- 6% — 36mm Heads

- 11 Re-operations Where A Stable

Cup Was Retained

- 5 Hips Treated Conservatively

- 1 Cup Revised For Instability

@ 2 Weeks Post-op

- 12 Additional Re-operations:

- 5 Hematomas

- 3 Femoral Fractures

- 2 Stem Loosenings

- 1 Superficial Infection

- 1 Modulus Mismatch

Conclusion:- Outstanding Mid-Term Survival

- Differences Between Patients, Surgeons,

Femoral Stems, Head Size, & Articulation

Types Did Not Affect Survival

- Re-operation For Instability Was Aided By

An Acetabular System That

Accommodates A Variety Of Liner & Head

Size Options

- 11 Out Of 12 Re-operations For

Dislocations, Stability Achieved With Cup

Retention2007 AAOS Annual Meeting

San Diego, CA

February 14 - 18, 2007

Poster #P077

Kirk Kindsfater, MD

Orthopaedic Center of the Rockies

Fort Collins, CO

William P. Barrett, MD

Valley Orthopaedic Associates/

Proliance Surgeons

Renton, WA

James E. Dowd, MD

Jordan-Young Institute

Virginia Beach, VA

Carleton B. Southworth, MS

DePuy Orthopaedics, Inc.

Warsaw, IN

Marilyn J. Cassell, RN

DePuy Orthopaedics, Inc.

Warsaw, IN


PLT-00026-00023


Engh, C. Anderson, et al. “A Randomized Prospective Evaluation of Outcomes After Total Hip Arthroplasty Using Cross-linked Marathon and Non-cross-linked Enduron Polyethylene

liners.” J Arthroplasty;21 (6 Suppl 2): 17.

Ceramtec, BIOLOX delta – Nanocomposite for Arthroplasty, The Fourth Generation of Ceramics, Scientific Information and

Performance Data, MT080013-US-750-0802

Collier JP, Currier BH, Kennedy FE, et al: Comparison of cross-linked polyethylene materials for orthopaedic applications.

Clin Orthop 2003; 414: 289-304.

Engh, C. Anderson, et al. “ A Comparison of a Second and a Third Generation Modular Cup Design”. Journal of Arthroplasty Vol. 25 No. 4, 2010.

Rack R, Pfaff HG. “A New Ceramic Material for Orthopaedics.” Proceedings of the 5th

International CeramTec Symposium, G. Thieme Verlag, Stuttgart, 2000. 141-145

VALIDATION


PLT-00026-00024


Source Quick ReferenceTECHNOLOGY VALIDATION MESSAGE VALIDATION SOURCE

Pinnacle Hip Solutions

99.9% Survivorship at 5 YearsKindsfater, K., W.P. Barrett, J.E.Dowd, C.B. Southworth and M.J. Cassell. “99.9% midterm survival of the Pinnacle multi-liner acetabular cup in a prospective multi-center study.” Poster Presentation #P077, AAOS, San Diego, CA. Feb. 14-18, 2007.


Zero incidence of lysis and backside wear withVIP taper vs. mechanical locking mechanism

Cara C.Powers, MD; Henry Ho, MS; Sarah E. Beykirch, BS; Cathy Huynh, BS; Robert H. Hopper, Jr., Ph.D.; C. Anderson Engh Jr. MD; Charles A. Engh MD “A Comparison of a Second and Third Generation Modular Cup Design: Is New Improved?” J Arthroplasty, Article in press as of September 2009.


Positive Pinnacle clinical outcomes in Australian Orthopaedic Association (AOA)

National Joint Replacement Registry

Revision Rates of Primary THA in AOA Registry (link below):

www.dmac.adelaide.edu.au/aoanjrr/publications.jsp?section=reports2009

Ultamet Metal-on-Metal Articulation

Lowest published ions in the C. Anderson Engh Jr., et al. 2008 John Charnley Award ~ Metal ion levels after metal-on-metal total hip arthroplasty: A randomized trial. Clin Orthop Related Res. October 2008.

Ultamet Metal-on-Metal Articulation

0.24% incidence of adverse metal response

The implant data from this multi-center metal-on-metal study can be found in the Advancing High Stability and Low Wear Clinical Guide (0612-17-508 Rev. 2).

aSphere 80% in-vitro reduction in wear debris Based on internal testing, this data can be found in the aSphere Design Rationale (0612-20-508).

aSphere 77% in-vitro reduction in associated ions Based on internal testing, this data can be found in the aSphere Design Rationale (0612-20-508).

MarathonIntroduced in 1998 as the

first FDA cleared cross-linked polyethylene in the industry

www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances

Marathon 95% in-vivo wear reduction at 5.7 yearsC. Anderson Engh Jr., MD et al. “A Randomized Prospective Evaluation of Outcomes After Total Hip Arthroplasty Using Cross-linked Marathon and Non–cross-linked Enduron Polyethylene Liners.” J Arthroplasty. 21 (6 Suppl 2); 17-25, 2006.

AltrX 92% in-vitro wear reductionY.-S. Liao, K. Greer, et al. “Effects of Resin and Dose on Wear and Mechanical Properties of Cross-linked Thermally Stabilized UHMWPE.” Society for Biomaterials, the 7th World Biomaterials Congress, Sydney, Australia, 2004.

AltrX BIOLOX® delta vs. metal heads

Y.-S. Liao, K. Greer, A. Alberts. “Effect of Head Material and Roughness on the Wear of 7.5 Mrad Crosslinked-Remelted UHMWPE Acetabular Inserts.” Orthopaedic Research Society 54th Annual Meeting, San Francisco, CA, 2008.

Gription friction vs. Trabecular Metal

J. Minter, et al. “Characterization of a New Rougher Porous Coating for Revision Reconstructive Surgery.” Orthopaedic Research Society 54th Annual Meeting, San Francisco, CA, 2008. Brett Levine. “A New Era in Porous Metals: Applications in Ortho-paedics.” Advanced Engineering Materials 2008, No. 9, pp. 788-792


PLT-00026-00025

26 | For internal use only. All outside distribution is prohibited. PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER. DEPUY019393912

PLT-00026-00026


The following section is designed to allow you to address the most common needs or objections of an HCP, by utilizing the various sections below.

Please refer to the appropriate page when preparing your call plans:

Page 28 Negotiate the Pinnacle®Acetabular System

Page 30 Negotiate Polyethylene

Page 36 Negotiate Metal Wear

Page 38 Negotiate aSphere

Page 40 Negotiate Ions

Page 42 Ions for Dummies Reference

NEGOTIATION


PLT-00026-00027


Negotiate the Pinnacle® Acetabular System

Needs

with 180° coverage of:

Porocoat: 30 years of clinical success in stability and

for bone in-growth

Gription:

porous, 300-micron pore size, smaller at substrate

2,3

system for the last 10 years and in one study showed

4

survivorship at 5 years5

Features & Benefits

liner types within one shell

2

proper alignment of the insert and liner prior to

impaction

cradles the liner, leaving a gap between the shell and

liner

minimum, to distribute the load across the entire liner-

shell interface

and RoM

NEGOTIATION


PLT-00026-00028


Objections

I am apprehensive about switching to a new system

accommodate multiple bearings while optimizing the head-to-shell ratio.

The extensive modularity of both the primary & revision systems promotes

confidence, having the widest range of options in response to any intra-

operative finding. For example, if you need to revise a metal liner or metal

delta

head while leaving the well fixed shell in place.

After being the only modular bearing system for ten years, our

competitors are now releasing more modular systems. However, they

6

delta


PLT-00026-00029


Negotiate Polyethylene

Needs

Features & Benefits

Marathon® poly was introduced in 1998 as the first FDA

cleared cross-linked poly in the industry and continues to

have very successful clinical outcomes. Engh et al showed

poly liners.7

As the leader, DePuy improved on this already clinically

which was designed for high demand patients.

eliminate free radicals, resulting in an oxidatively stable

material, with excellent mechanical integrity.

irradiated at 7.5 Mrads to maximize Wear Resistance

without sacrificing the Mechanical Integrity we enjoy

with Marathon polyethylene

resistance and mechanical integrity

AltrX

WearResistance

Oxidative Stability

Mechanical Integrity

when compared to Marathon.2

polyethylene and decreases the risk of failures due to

impingement or rim loading.8

polyethylene liners designed to enhance stability with

liners are available in lateralized and face changing

designs, allowing you to achieve high stability without

compromising wear resistance.

NOTE: Reduced wear claims are based on the results

of in-vitro hip wear simulator tests which have not

been shown to quantitatively predict clinical wear

performance.

NEGOTIATION


PLT-00026-00030


Objections

If Marathon poly is performing well clinically why did DePuy introduce AltrX?

DePuy was the first company to receive FDA clearance

and offer a cross-linked polyethylene, Marathon. We

patient and are committed to continue delivering high

stability, low wear solutions for you and your patients.

Marathon polyethylene.2

As the leaders in bearing technology we continuously

challenge ourselves to deliver advanced solutions for

your high demand patients.

Objection from X3 User: I like to maximize the head-to-shell ratio to enhance stability and optimize range of motion. With X3 I am able to use a 36 femoral head with a 48 neutral liner. What are my options with AltrX?

I understand maximizing head-to-shell ratio for your

patients is critical to enhance stability and range of

lateralized liner. This provides up to 142° range of

motion and 19 mm jump distance.

Objection from X3 User: I am concerned that remelting weakens the polyethylene.

Other than Stryker, DePuy and the other manufacturers

remelt to eliminate free radicals, since this is the only

proven way to ensure oxidative stability and that the

mechanical strength of the poly will not be compromised

over time. We have proven the mechanical integrity

over Marathon, the mechanical integrity is unchanged

1020 resin.

Company Brand Joint Resin (GUR)Radiation

Source Dose Stabilization Process Sterilization

BiometHip 1050 Gamma 5.0 Mechanical anneal ETO

E-Poly Hip 1050 Gamma 10.0 Vitamin E stabilized Gamma

DePuyMarathon® Hip 1050 Gamma 5.0 Remelt Gas Plasma

Hip 1020 Gamma 7.5 Remelt in Argon Convection Gas Plasma

Smith & Nephew Hip, Knee 1050 Gamma 10.0 Remelt ETO

Stryker Hip, Knee 1020 Gamma 9.0 Sequential thermal anneal Gas Plasma

Zimmer Longevity® Hip 1050 E-Beam 10.0 Remelt Gas Plasma

Zimmer Prolong™ Knee 1050 E-beam 6.5 Remelt Gas Plasma

Co

mp

etit

ive

Co

mp

aris

on

poly bearings. Tell your customers this powerful example: “The

18

16

14

12

10

8

6

4

2

028 mm 32 mm 36 mm 40 mm 44 mm 48 mm

Co

mp

ress

ion

Str

eng

th

What is the Wear Resistance?


PLT-00026-00031


Negotiate BIOLOX delta

Needs

Features & Benefits

forte was entirely alumina

delta is the new 4th generation ceramic

material matrix composite:

matrix act like airbags to absorb impact forces

counteract their propagation

the crack path to neutralize its energy

TOUGHNESS

due to the Zirconia particles & Strontium Aluminate

crystals

STRENGTH

delta is considerably higher

than previous ceramics. The bending strength is not

affected by multiple autoclave sterilizations.

delta is one of the most wear resistant bearings

in orthopaedics because:

from 3rd body wear particles

delta to

offer significant wear reduction regardless of the liner

material

constructs, due to their smooth hard surface

delta is a great alternative for patients known

to be sensitive to CoCr

NEGOTIATION


PLT-00026-00032


Objections

I am concerned about the fracture risk of ceramics

Based on the fracture risks of previous ceramic materials,

I can understand your trepidation.

delta

that utilizes a matrix composite instead of a purely

alumina composition like the commonly used cream-

forte.

Zirconia particles in the aluminum oxide matrix act like

airbags by absorbing impact forces and producing local

pressure peaks to counteract crack propagation.

Strontium Aluminate crystals prevent cracks & crack

propagation by neutralizing the crack path and energy.

I want the lowest wear bearing for my THA patients

delta

to metal heads, promotes fluid film lubrication. This

fluid barrier between bearing surfaces results in a wear

reduction regardless of the liner selected. Additionally,

delta has the benefit of resisting

scratching or damage from 3rd body debris.

Airbag Function Crack Deflection

Plat

elet

Zirconium Oxide

Aluminum Oxide


PLT-00026-00033


Negotiate Stability & Range of Motion (RoM)

Needs

Features & Benefits

morbidity and mortality rates are significantly higher as

compared to primaries 9,10,11

Heads are available in various neck lengths to allow you

to restore appropriate femoral neck sizes, offset, and leg

length, while reducing impingement risks, all without

Pinnacle shells and Ultamet liners offer 2mm of

lateralization to decrease the risk of dislocation and

increase RoM or stability

Ultamet MoM offers a high femoral-head-to-acetabular-

cup ratio that optimizes stability and range of motion

For example:

stem has up to 146° RoM

up to 159° RoM2

MoM bearings.5

With regards to stability, Gription offers a very high

2,3

Dislocations are a primary cost driver for hospitals and

healthcare payers. Larger diameter MoM bearings have

the potential to reduce these costs by reducing the risk of

dislocation.9,10,12

NEGOTIATION


PLT-00026-00034


Objections

I am concerned about hard bearings, why should I risk it?

DePuy is committed to high stability in THA. Dislocation

is a major contributor to revisions, adversely impacting

hospitals, but much more importantly, the patient.

Based on our conversation, may I have 10 minutes of

your time to share how I believe Pinnacle can address the

See FEATURES & BENEFITS around:

length without losing RoM

DePuy designed the Pinnacle system to offer the patient:

head-to-shell ratios


PLT-00026-00035


Negotiate Metal Wear

Needs

Features & Benefits

DePuy Ultamet MoM offers surgeons and patients the

benefit of reduced wear. Less wear can lead to lower

failure rates or fewer premature revisions.

result in lower wear due to advanced manufacturing

processes

generation

hard-on-hard bearings allowing the fluid to bear the

sliding forces rather than the surfaces of the head and

liner 13

reduces wear

Based on laboratory studies, Pinnacle MoM bearings

have been shown to offer remarkably High Stability and

Low Wear.2

Research has shown that acetabular shells like Pinnacle

may deflect in hard bone especially if the acetabulum is

under-reamed by 2mm or more. However, Dr. William

Griffin demonstrated that all deflection was eliminated

when a CoCr insert such as Ultamet was impacted into

a deflected shell. He also demonstrated in cadavers that

the shell deflection disappeared after approximately 4

hours as the bone relaxed.14

NEGOTIATION


PLT-00026-00036


Objections

I am concerned about metal wear

team has completed extensive research to understand

the factors leading to increased wear in a MoM hip

prosthesis. From this tribology, DePuy designed and

which have numerous features that work to reduce metal

Decreasing wear can lower the risk of premature

surface roughness, high carbon content and optimized

diametrical clearance, aid in maximizing fluid film

lubrication between the head and liner, which can

potentially lead to even further reduction of wear debris

exposure to the patient.


PLT-00026-00037


Negotiate aSphere™

Needs

Features & Benefits

DePuy is redefining metal-on-metal bearings with

aSphere M-Spec metal heads within Pinnacle Hip

Solutions.

DePuy aSphere M-Spec features precision contoured

femoral heads, using technology borrowed from the

optics industry.

This contouring approximates the shaping that occurs

naturally during the in-vivo run-in wear phase. The

following reductions resulted as compared to the industry

leading Ultamet metal-on-metal:

The Pinnacle aSphere M-Spec heads pre-contoured zone

encompasses the areas of greatest and most frequent

contact during routine activities.

The symmetric nature of the aSphere M-Spec head does

not require special orientation by the surgeon to ensure

the articulation zone is in the proper location.

The DePuy aSphere M-Spec Femoral Heads are available

in the same sizes of 36, 40 and 44 options as the DePuy

by optimizing the head-to-shell ratios.

The DePuy aSphere M-spec maintains the proven 80 –

120 micron clearance at the cup rim optimal for fluid film

lubrication.

NOTE: Reduced wear claims are based on the results

of in-vitro hip wear simulator tests which have not

been shown to quantitatively predict clinical wear

performance.

NEGOTIATION


PLT-00026-00038


Objections

If you can’t even see a difference between M-Spec and aSphere, could it really make that much of a difference?

DePuy had to adopt technology from the optics industry

in order to produce aSphere M-Spec Femoral Heads. We

already had the lowest ion levels of any MoM bearing

work to further reduce in-vitro wear and release of ions

in patients.

The fruit of the work performed by DePuy researchers is

metal ions as compared to the industry leading Ultamet

metal-on-metal.2

Smith & Nephew – R3 Objection: DePuy’s metal-on-metal features dangerously small clearances (equatorial clearance of 80-120 microns and polar clearance of 40 microns) where as R3 features a 200-300 microns of diametrical clearances.

Several peer reviewed publications have demonstrated

that small clearances do in fact lead to a reduction in

metal wear and ions. In fact Smith & Nephew designing

surgeon, Mr. Derek McMinn, has produced data for the

past two Orthopaedic Research Society meetings which

validate smaller clearances vs. larger clearances consistent 15,16,17

Biomet – Magnum Objection: Pinnacle metal-on-metal does not offer the optimized head to shell ratio which is featured with the Magnum.

Pinnacle aSphere M-Spec metal-on-metal not only offers

the potential for three times less metal ion exposure

than the Magnum, it also provides the advantages of

head-to-shell advantage is optimized at the 36mm head

are minimal with regards to the benefit of stability. Above

sensitivity to cup placement.18

Thank you for your time and for listening to the many

ways in which DePuy demonstrates our commitment to

increasing stability while lowering bearing wear.


PLT-00026-00039


Negotiate Ions Ions for Dummies

Needs

Features & Benefits

When an HCP communicates concerns of adverse

reactions to metal like “hyper-sensitivity”, ask whether

the concern is related to metal sensitivity or reactivity.

reactivity can have circulating Co and Cr ion levels in

loading of misaligned cups.19, 20, 21

delta heads will reduce the metal wear patients are

exposed to since significantly more wear is released from

the metal head compared to the metal liner in a MoM

bearing.7

If concerned about metal reactivity, clarify that not

all MoM implants are created equal. The literature on

adverse outcomes from MoM implants is directed toward

monoblock or resurfacing designs specifically. Metal

reactivity from monoblock systems is more specifically

linked to poor cup placement, with excessive inclination

of dislocations, edge loading, and impingement.22,23,24,25

2010 AAOS research defined the minimal Co and Cr ion

24,25

The M-Spec heads-on-Ultamet liners have the lowest

published MoM ion levels in the industry at 0.73 ppb.26

This is an entire magnitude lower than the upper limits

for concern found in the AAOS papers referenced.

Additionally, Dr. MacDonald found that the pre-

implantation levels of Co and Cr in this same cohort

ranged from 0.1 to 0.3 ppb.26

NEGOTIATION


PLT-00026-00040


Objections

I use mostly Poly-on-Metal since I have concerns that patients could have an adverse Metal-on-Metal response.

you. May I ask you a question regarding the exact nature

that has been reported for decades, not specific to MoM

more recently being reported with high levels of metal

delta-on-

As you know, there has been a substantial amount of

literature recently reporting MoM patients with clinical

symptoms associated with high metal ions levels. If

it would stand out that the adverse outcome is almost

entirely related to monoblock or resurfacing designs, not

modular MoM systems like Pinnacle.

Two papers at the 2010 AAOS linked metal reactivity to

monoblock systems in misalignment.

Our Ultamet modular MoM was found to have the

lowest published ion levels in the industry at 0.73 ppb.

These results put Pinnacle MoM a full magnitude lower

than the upper limit threshold of ion levels for metal

reactivity clinical symptoms as presented in the 2010

AAOS meeting.

In the absence of a patient having true metal sensitivity,

Pinnacle MoM is the least likely MoM bearing on the

market to lead to metal reactivity according to the

industry comparison studies.


PLT-00026-00041


Ions for Dummies This section provides key definitions and science you should understand about ions

Metal Sensitivity

high levels of Metal-on-Metal wear. This lymphocytic

associated cystic masses or “pseudotumor.” Onset

of symptoms is usually within a few years.i These

reactions are not specific to hip implants, and are 25,27,28,29

Metal Reactivity

Metal reactivity describes the reported reactions

seen with very high levels of metal wear from MoM

bearings improperly positioned at high inclination

angles or excessive anteversion. This is also be called

a foreign body, macrophage inflammatory, or adverse

local tissue response due to the large CoCr particles

created from edge loading.25,30 Patients with this

reaction have circulating Co and Cr ion levels that

can be elevated to double digit parts per billion 31,32 Both metal reactivity and sensitivity can

cause osteolysis, groin pain, and decreased RoM.33

Cancer Risks

The cancer risk for metal-on-metal bearing

is no greater than that associated with a

metal-on-polyethylene bearing.34,35

Reactivity with Monoblocks

The vast amount of literature on adverse outcomes

from MoM implants has been concentrated on

monoblock or resurfacing designs specifically. The

reasons for the difference between monoblock and

modular MoM systems are multifactorial in nature.

There is a growing body of literature that specifically

links the metal reactivity in monoblock systems to poor

cup placement. Increased inclination angles above

45 degrees and anteversion above 20 degrees can

result in increased risks of dislocation, impingement,

edge loading, and reduced range of motion.25,27,28,29

2010 AAOS

There is emerging evidence that clinical symptoms

will not occur unless the patient is found to have

or chromium ions in serum and blood.16,17

pre-implant ion levels may also serve as a good baseline

point for discussion, as multiple factors, including

diet, can contribute to the CoCr ions in the body.

Ultamet MoM was found to have less than 0.73 ppb

industry.26 MacDonald found that the population base-

line for circulating CoCr ion levels averaged between

0.15 to 0.3 ppb. Therefore, Pinnacle Ultamet MoM

minimally increases the baseline ion levels. Another

study found the incidence of an adverse local response

from a MoM bearing when using an Ultamet liner 2

NEGOTIATION


PLT-00026-00042


References

1. Integrity Selling for the 21st Century, Ron Willingham References on the Design Rationales and Clinical Compendium, etc

2. Data on file DePuy Orthopaedics, Inc.

Zimmer website www.Zimmer.com

4. Kindsfater, K., Barrett, W., Dowd, J., Southworth, C., Cassell, M. Midterm Survival of the Pinnacle Multi-liner Acetabular Cup in a Prospective Multi-Center Study. Proceedings of the 74th Annual Meeting of the American Academy of Orthopaedic Surgeons; 2007 February 14-18. Poster No. P077.

5. Survivorship of the Pinnacle® Acetabular Cup System

6. Australian Orthopaedic Association National Joint Registry Annual Report 2009. Retrieved from: http://www.dmac.adelaide.edu.au/aoanjrr/documents/aoanjrrreport_2009.pdf

7. C. Anderson Engh Jr., MD et al. “A Randomized Prospective Evaluation of Outcomes After Total Hip Arthroplasty Using Cross�linked Marathon and Non–cross�linked Enduron Polyethylene Liners.” J Arthroplasty. 21 (6 Suppl 2); 17�25, 2006.

8. Orthopaedic Research Society, 2007, P1784

9. Mahomed, N. N. et al.: Rates and outcomes of primary and revision total hip replacement

10. Bozic KJ et al. The epidemiology of revision total hip arthroplasty in the United States. In press, J Bone and Joint Surg Am 2008.

11. Gary Warriner, MSc, Senior Biostatistician†; Kristine Lee, MPM, Senior Technical Writer†Joaquin Sanchez-Sotelo, George J. Haidukewych and Carol J. Boberg. “Hospital Cost of Dislocation after Primary Total Hip Arthroplasty.” J. Bone Joint Surg. Am. 88:290-294, 2006.

12. Berry DJ, von Knoch M, Schleck CD, et al. The cumulative long-term risk of dislocation after primary Charnley total hip arthroplasty. J Bone Joint Surg Am 2004; 86-A:9-14.

Chan FW, Bobyn JD, Medley JB, Krygier JJ, Tanzer M. The Otto Aufranc Award. Wear and

14. Matthew Squire, William Griffin, J. Bohannon Mason, et al. “Acetabular Component Deformation with Press-Fit Fixation.” JOA Vol. 21 No. 6 Suppl. 2 2006.

15. Metal Ion levels in low clearance hip resurfacings Hena K. Ziaee1, Joseph Daniel1, Chandra Pradhan2, Derek McMinn2 1Research, The McMinn Centre, Birmingham, United Kingdom; 2The McMinn Centre, Birmingham, United Kingdom [email protected]

16. Dowson D, Hardaker C, Flett M, Isaac GH. A hip joint simulator study of the performance of metal-on-metal joints: part I: the role

17. Dowson D, Hardaker C, Flett M, Isaac GH. A hip joint simulator study of the performance

18. Cuckler, JM, Moore, KD,Lombardi Jr., AV, et. al. Large verses Small Femoral Heads

19. Jacobs JJ and Hallab NJ. Loosening and osteolysis associated with metal-on-metal bearings: A local effect of metal hypersensitivity? J Bone Joint Surg 88A: 1171 – 1172, 2006.

20. Survivorship of the Pinnacle® Acetabular Cup System

21. Pamela L. Plouhar, Ph.D., Vice President Worldwide Clinical Affairs; Rodrigo Diaz, MD, Manager, Clinical Research;

22. De Haan R, Campbell PA, Su EP, De Smet KA. Revision of metal-on-metal resurfacing arthroplasty of the hip: the influence of malpositioning of

De Haan R, Pattyn C, Gill HS, Murray DW, Campbell PA, De Smet K. Correlation between inclination of the acetabular component and metal ion levels in metal-on-metal hip resurfacing replacement. J Bone Joint Surg Br. 2008 Oct;90(10):1291-7.

24. Hart A, Bandl A, Lenihan J, Magglore P, Sampson B, & Skinner J. High blood cobalt levels can be used to predict failure of metal on metal (MOM) hips, 2010 AAOS Podium no. 007, New Orleans, LA

25. Campbell PA, Van Orsouw M, Singh Gill H, DeSmet KA. Interpretation of Metal Ion Levels after Metal-On-Metal Hip Resurfacing, 2010 AAOS Poster P100, New Orleans, LA

26. C. Anderson Engh Jr., et al. 2008 John Charnley Award ~ Metal ion levelsafter metal�on�metal total hip arthroplasty: A randomized trial. Clin Orthop Related Res. October 2008.

27. Svensson O, Mathiesen EB, Reinholt FP and Blomgren G. Formation of a fulminant soft-tissue pseudotumor after uncemented hip arthroplasty.

28. Hallab, N., Merritt, K., Jacobs, J.J: Metal sensitivity in patients with

29. Willert H-G, Buchhorn GH, Fayyazi A, Flury R, Windler M, Köster G, and Lohmann CH. Metal-on-metal bearings and hypersensitivity inpatients with artificial hip joints. A

Pandit H et al. Pseudotumours associated with metal-on metal hip resurfacings. J Bone and Joint Surg 90-B: 847-851, 2008.

Langton DJ, Jameson SS, Joyce TJ, Webb J, Nargol AV. The effect of component size and orientation on the concentrations of metal ions after resurfacing

De Haan R, Pattyn C, Gill HS, Murray DW, Campbell PA, De Smet K. Correlation between inclination of the acetabular component and metal ion levels in metal-on-metal hip resurfacing replacement. J Bone Joint Surg Br. 2008 Oct;90(10):1291-7.

Jacobs JJ and Hallab NJ. Loosening and osteolysis associated with metal-on-metal bearings: A local effect of metal hypersensitivity? J Bone Joint Surg 88A: 1171 – 1172, 2006.

Tharani, R. Dorey, F. J. and Schmalzried, T.P.: The risk of cancer following total

A ulakh T and Richardson JB: Metal-On-Metal: What is the risk of cancer? Second annual comprehensive course on total hip resurfacing arthroplasty. Los Angeles, CA, October, 2008.

De Haan R, Campbell PA, Su EP, De Smet KA. Revision of metal-on-metal resurfacing arthroplasty of the hip: the influence of malpositioning of

Hart A, Bandl A, Lenihan J, Magglore P, Sampson B, & Skinner J. High blood cobalt levels can be used to predict failure of metal on metal (MOM) hips, 2010 AAOS Podium no. 007, New Orleans, LA

Campbell PA, Van Orsouw M, Singh Gill H, DeSmet KA. Interpretation of Metal Ion Levels after Metal-On-Metal Hip Resurfacing, 2010 AAOS Poster P100, New Orleans, LA

Callahan Metal An analysis of cup positioning in total hip arthroplasty:

40. Schmalzried TP, Guttmann D, Grecula M, Amstutz HC. The relationship between the design, position, and articularwear of acetabular components inserted without cement and the development of pelvic osteolysis. J Bone Joint Surg Am. 1994 May;76(5):677-88.

41. C. Anderson Engh Jr., et al. 2008 John Charnley Award ~ Metal ion levelsafter metal�on�metal total hip arthroplasty: A randomized trial. Clin Orthop Related Res. October 2008.

42. Willert H-G, Buchhorn GH, Fayyazi A, Flury R, Windler M, Köster G, and Lohmann CH. Metal-on-metal bearings and hypersensitivity in patients with artificial hip joints. A

Jacobs JJ & Hallab NJ. Loosening and osteolysis associated with metal-on-metal bearings: A local effect of metal hypersensitivity? J Bone Joint Surg 88A: 1171-72, 2006.

44. Pandit H et al. Pseudotumours associated with metal-on metal hip resurfacings. J Bone and Joint Surg 90-B: 847-851, 2008.


PLT-00026-00043


CLOSE

Purpose:To get a mutually beneficial decision that moves you to the next incremental step

Note: Asking for a commitment on your pre-call plan objective is easier when you have:

for “opinions” rather than for decisions

“At this point, what have I not fully explained?”

“Who might have some decision input that we haven’t gotten agreement from?”

“Do you feel confident at this point that the benefits of this product outweigh the costs?”

“What should I now know about your decision process for making a change like this?”

“Do you think this will create the desired outcome we discussed?”


PLT-00026-00044


Close Tip 1: Restate how benefits will outweigh the costs

Close Tip 2:

comprehensively and now need to ask questions to find out if there is an issue

received a negative response, find out what variable, if it were to change, might lead the HCP to want to talk about this again with you

to reopen discussions, such as:

“Do you still have the same needs that we previously discussed?”

“Had I misinterpreted your level of interest?”

“Have I sufficiently proven everything you need to believe you’ll get the desired benefits?”

“Have questions or concerns popped up in your mind that we haven’t discussed before?”

“Do we need to bring anyone else into the discussion we haven’t yet?”

“What can I do at this point to best serve you?”

Close Tip 3:

& behaviors impact your close

time to close, being pushing, and revealing that your desire to make the sale outweighs

There are many suggestions in the Integrity Selling for the 21st Century by Ron Willingham should you need direction on how to make progress in the area of your selling beliefs and behaviors


PLT-00026-00045

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