CONSTRUCT RATIONALE BROCHURE

Introduction

‘Improving people’s lives... together’ is the driving force of the CORAIL® PINNACLE® Construct Solution and stands for great people working together, and also for great products working together - both are critical to achieving the ultimate goal, to improve people’s lives.

Building on the great HERITAGE, the good long-term CLINICAL RESULTS and the very positive long-term SURGEONS’ EXPERIENCE from around the world, CORAIL PINNACLE is able to deliver more than excellent features and benefi ts of two independent products – it’s about trust and confi dence in a construct solution. Additionally, it offers great FLEXIBILITY and VERSATILITY with more than 1 million possible construct combinations1 available within the CORAIL PINNACLE family of products. Finally, the construct strives to improve people’s lives together in more than 75 countries2 around the globe and therefore creates the CORAIL PINNACLE WORLD.

CORAIL PINNACLE – Improving people’s lives…together.

HeritageHeritage

CORAILCORAILPINNACLEPINNACLE

WorldWorld

ClinicalClinicalResultsResults

Surgeons’Surgeons’ExperienceExperience

Heritage

CORAILPINNACLE

World

Versatility and Versatility and FlexibilityFlexibility

Versatility and Flexibility

ClinicalResults

Surgeons’Experience

Improving people’slives…together

1986CORAIL Stem

2003COXA VARA

2002CORAIL AMT 2004

CORAIL High Offset2012

In Q4 2012, CORAIL achieved over 1 million unit

sales worldwide since its introduction5

2008CORAIL became the most

implanted cementless stem solution in the Australian Orthopaedic Association

National Joint Replacement Registry4

2005CORAIL became the most

implanted cementless stem solution in the National Joint

Registry of England and Wales3

HeritageHeritageHeritage

2004Size 6 Dysplasia

2000PINNACLE

2003DUOFIX™ Porous Coating with HA

1998MARATHON™ cross-linked polyethylene

1977POROCOAT®

Porous Coating

1998MARATHON™

2007ALTRX™

Cross-Linked Polyethylene

2009GRIPTION® Porous

Coating2006

PINNACLE became the most implanted

cementless acetabular cup solution in the National Joint

Registry of England and Wales8

2011In Q3 2011, PINNACLE

achieved over 1 million unit sales worldwide since its

introduction6

2008PINNACLE became the 2nd most implanted

cementless acetabular cup solution in the Australian Orthopaedic

Association National Joint Replacement

Registry7

the most implanted

Registry of England

2003CERAMAX™

2004ESC™ and ES3™ Enhanced Stability

Liners2004PINNACLE Bantam

ClinicalClinicalResultsResultsClinicalResults

Over 68,000 documented CORAIL PINNACLE construct implantations in registries

96.4%

95.9%

1.37%

CORAIL PINNACLE is the most implanted combination in cementless hip joint reconstruction in Australia showing a 96.4 % survival rate at 5 years in

14,961 implantations.9,10

CORAIL PINNACLE is the most used combination in hip joint reconstruction in England and Wales showing a 95.9% survival rate at 7 years in 54,019 implantations.11

Low 1.37% revision rate for the CORAIL PINNACLE with ceramic on polyethylene bearing after 5 years in the National Joint Registry of England and Wales.12

Combination Implantations Year 1 Year 3 Year 5 Year 7Ceramic-on-ceramic 17971 0.87% (0.74%-1.03%) 1.80% (1.56%-2.07%) 2.49% (2.10%-2.95%) -Ceramic-on-metal 1652 0.38% (0.17%-0.85%) 2.95% (1.77%-4.91%) - -Ceramic-on-polyethylene 4327 0.61% (0.41%-0.90%) 0.96% (0.66%-1.40%) 1.37% (0.88%-2.14%) -Metal-on-metal 11339 0.83% (0.68%-1.02%) 2.32% (2.04%-2.64%) 4.28% (3.77%-4.85%) -Metal-on-polyethylene 18086 0.81% (0.68%-0.95%) 1.40% (1.20%-1.62%) 1.66% (1.41%-1.96%) 2.05% (1.57%-2.68%)

Combination Implantations Year 1 Year 3 Year 5 Year 7CORAIL, PINNACLE 54019 0.80% (0.73%-0.89%) 1.80% (1.67%-1.95%) 2.84% (2.61%-3.10%) 4.12% (3.51%-4.85%)

National Joint Registry for England and Wales. Revision rates (all-cause) for main hip stem and cup combinations (95% confi dence intervals).11

National Joint Registry for England and Wales. Revision rates (all-cause) for most commonly used brands for hip replacement by fi xation and

bearing surface (95% confi dence intervals).12

Australian Orthopaedic Association National Joint Replacement Registry. Yearly Cumulative Percent Revision of Primary Total Conventional Hip

Replacement with Cementless Fixation (95% confi dence intervals).9

Combination Year 1 Year 3 Year 5CORAIL, PINNACLE 1.6% (1.4%-1.8%) 2.6% (2.3%-2.9%) 3.6% (3.1%-4.1%)

Surgeons’Surgeons’ExperienceExperienceSurgeons’Experience

Reliable combination“I use CORAIL PINNACLE because I do believe, and I consider, based on the scientifi c data that it’s one of the most reliable combinations, and this is something that we need to be able to tell our patient, that implanting this combination will provide long term results without any drawbacks or specifi c problems.”

Reliable technique“It is extremely important to have a reliable and reproducible technique on implants because we are addressing more and more patients, and we are educating more and more surgeons.”

Used in 100% of my patients“It became obvious quite quickly that CORAIL was an implant that was suitable for all, so by the middle of 2002, I used it in every patient. I had been using the DURALOC® cup for every patient, so when PINNACLE became available in 2005, I used the CORAIL PINNACLE construct in 100% of my patients.”

Simple, reliable, easy technique to teach, long history of good results and pleased patients!“The construct of the CORAIL and PINNACLE has been excellent for me. There are several reasons why I think it’s been good. Firstly it’s a simple, reliable technique. Secondly it’s something I can teach to the juniors easily. Thirdly there’s a long history of good results. And fourthly I’ve got a bunch of patients who are extremely happy with their results and that feedback is important to me, and I’m sure in the future that construct will go on being used in Warwick.”

Simple solution, reliable and reproducible surgical technique, fast and effi cient – reliable patient results“So, I started using the CORAIL PINNACLE combination as I’d been exposed to this in the last year of my training and it really struck me as a very simple solution, easily reliable and reproducible, surgical technique that was relatively fast and effi cient. And above all, you know, seeing the patients clinically afterwards gave very reliable function results and the x-rays are always reliably reproduceable and overall I was just really impressed with the whole system.”

Consistency“So, in a world where there’s been obviously lots of modifi cations and other companies producing similar products, I think we have to be very careful and be aware of seemingly very minor modifi cation to a system...”

Mr Steve Young, UK Dr Tarik Ait Selmi, France Prof Tim Board, UK

I use CORAIL PINNACLE for every patient, without exception“The only combination I’ve used is CORAIL PINNACLE and I use that combination without exception. I use it because it’s got a proven track record, it’s simple to use, if used properly, and we know that it gives good long term results.”

Simple Re-usable Technique for Teaching/Training“For me it’s important to have a straight forward, reproducible technique, because I have fellows, so on every case I do, I’m training, and therefore it’s valuable that I’m doing the same thing, at the same time in every operation.”

Proven and versatile“I use the CORAIL PINNACLE construct because, the results are very good, they are very well proven, and it’s a very versatile system, and I can use the system on almost all my patients.”

Heritage, evidence, bone sparing and fl exibility“I use the CORAIL PINNACLE combination because it has a great clinical heritage, there’s really good evidence base for both components and I believe both components provide a conservative option in total joint reconstruction as they are bone sparing and they have huge fl exibility to address all the clinical problems that present to the hip surgeon.”

Cost effective and suits almost all patients“I use CORAIL PINNACLE because of the cost effectiveness in a small set up like the private hospital where I work and also it suits all my patients, all my pathologies I have to face on a day to day basis.”

Prof David Beverland, UK

Dr Helge Wangen, Norway

Prof Ian Learmonth, South Africa

Dr Jens Boldt, Switzerland

PINNACLE Cup, Coating and Liner availability varies by size. For a complete reference please refer to the PINNACLE Product Guide 9068-81-200.

Versatility and Versatility and FlexibilityFlexibility

Versatility and Flexibility

Cups

Liners

Heads

CERAMAX

ALTRX

MARATHON

ULTAMET™

Coatings

POROCOAT DUOFIX

GRIPTION

100

Sector

300

Multihole

Ceramic

Metal

Bantam

More than 1 million construct combinations* available

within the CORAIL PINNACLE family of products.1

* Cup, Liner, Head and Stem

A simple solution for a broad variety of patients

Stems

Standard KSNo Collar

Size 8 – 20

Standard KACollar

Size 8 – 20

High Offset KHONo Collar

Size 9 – 20

COXA VARA KLA CollarSize 9 – 20

DDHNo Collar

Size 6

DDHCollarSize 6

3. Surgeons’ Experience3. Surgeons’ Experience3. Surgeons’ Experience3. Surgeons’ Experience3. Surgeons’ Experience3. Surgeons’ Experience3. Surgeons’ Experience

CORAILCORAILPINNACLEPINNACLE

WorldWorld

CORAILPINNACLE

World

CORAIL• In December 2012, CORAIL achieved over 1 million

unit sales worldwide since its introduction5

• More than 650 patients treated each day

• Striving to improve people’s lives in more than 75 countries around the globe

PINNACLE• In August 2011, PINNACLE achieved over 1 million

unit sales worldwide since its introduction6

• More than 750 patients treated each day

• Striving to improve people’s lives in more than 75 countries around the globe

Availability of CORAIL PINNACLE

3. Surgeons’ Experience3. Surgeons’ Experience3. Surgeons’ Experience3. Surgeons’ Experience3. Surgeons’ Experience3. Surgeons’ Experience3. Surgeons’ Experience

CORAIL PINNACLE is available in more than 75 countries around the globe

Great peopleworking together

Great productsworking together

Improving people’slives…together

Improving people’slives…together

Great peopleworking together

Great productsworking together

References

1. 2013 CORAIL PINNACLE Portfolio data on file, DePuy International Ltd.

2. 2013 sales data on file, DePuy International Ltd.

3. National Joint Registry for England and Wales, 9th Annual Report 2012. Available from URL: http://www.njrcentre.org.uk/njrcentre/default.aspx. Figure 2.11.

4. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide: AOA; 2012. Available from URL: https://aoanjrr.dmac.adelaide.edu.au/ annual-reports-2012. Table HT7.

5. 1986 - 2012 sales data on file, DePuy International Ltd.

6. 2000 - 2011 sales data on file, DePuy International Ltd.

7. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide: AOA; 2012. Available from URL: https://aoanjrr.dmac.adelaide.edu.au/annual-reports-2012. Table HT5.

8. National Joint Registry for England and Wales, 9th Annual Report 2012. Available from URL: http://www.njrcentre.org.uk/njrcentre/default.aspx. Figure 2.12.

9. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide: AOA; 2012. Available from URL: https://aoanjrr.dmac.adelaide.edu.au/annual-reports-2012. Table HT57.

10. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide: AOA; 2012. Available from URL: https://aoanjrr.dmac.adelaide.edu.au/annual-reports-2012. Table HT58.

11. National Joint Registry for England and Wales, 9th Annual Report 2012. Available from URL: http://www.njrcentre.org.uk/njrcentre/default.aspx. Table 3.9.

12. National Joint Registry for England and Wales, 9th Annual Report 2012. Available from URL: http://www.njrcentre.org.uk/njrcentre/default.aspx. Table 3.11.

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CA#DPEM/ORT/0213/0048 version 1 Issued: 03/13

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