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One Surgeon. One Patient.

This publication has been issued by:European Central MarketingWaterton Industrial EstateBridgendSouth WalesCF31 3XA +44 [0] 1656 655221+44 [0] 1656 645454

Responsible Manufacturer: Biomet Spain Orthopaedics S.L.P.O. Box 96Calle Islas Baleares 5046988 Fuente del JarroValenciaSpain+34.96.137.9500+34.96.137.9510

www.biomet.com

E1 Tapered LinersDesign Rationale

Disclaimer

This publication and all content, artwork, photographs, names, logos and marks contained in it are protected by copyright, trademarks and other intellectual property rights owned by Biomet or its affiliates or licensed to Biomet or its affiliates. This brochure must not be used, copied or reproduced in whole or in part for any purposes other than marketing by Biomet or its authorised representatives. For other purposes is prohibited.

Biomet does not practice medicine and does not recommend any particular orthopaedic implant or surgical technique for use on a specific patient. The surgeon who performs any implant procedure is responsible for determining and utilising the appropriate techniques for implanting prosthesis in each individual patient.

Biomet is not responsible for selection of the appropriate orthopaedic implant or surgical technique, nor does it advocate a particular technique to be utilised on an individual patient.

© Biomet 2011

E1 is a registered trademark of Biomet UK Ltd.

E1 Tapered Liners

Design Rationale

Contents

Ultra Low Wear 2

Tri Bearing Options 3

Easier Revisions 4

Reduced Cup Inventory 4

Maximised Bearing Diameter 4

Optimal Mobility and Limited Risk of Dislocation 5

Stability 5

Fatigue Resistance 5

Liner Options 6

Ordering Information 7

References 9

E1 Tapered Liners

Design Rationale

Ultra Low Wear

E1 Antioxidant Infused Technology surpasses the limitations of first generation highly crosslinked polyethylene. This unique technology is the first vitamin E stabilized highly crosslinked polyethylene bearing that has been shown in testing to provide high mechanical strength and true oxidative stability:

• Ultra low wear rates with large heads: 95 percent wear reduction when comparing 40mm E1 liners with 36mm ArCom liners and 99 percent wear reduction with smaller femoral heads when compared with already low wear rates of ArComXL polyethylene (figure 1 & 2)

• Fatigue strength greater than first generation re-melted HXLPE1,2,3

• Stronger than sequentially crosslinked and annealed materials after an environmental stress cracking (ESC) study1

• True oxidative protection without re-melting: no evidence of measurable oxidation1

CleanConditions

Abrasive Conditions

40mmE1

36mmArCom*

0

10

20

30

40

50

60

70

80Vo

lum

etric

Wea

r Rat

e m

m3 /1

06 Cyc

les

Volumetric Wear 5 million cycles on a hip simulator

36mm and 40mm head size

2.7

55.4

8.9

72.3

The E1 tapered Liners complement the existing family of low wear hard bearing liner options used with the Exceed ABT taperfit cups. E1 Antioxidant Infused Technology prevents oxidative degradation of the polyethylene, and offers an alternative ultra low wear soft bearing option.

The tri-bearing Exceed ABT acetabular platform addresses patients and practice needs by combining technological development in large diameter bearings with clinically proven fixation methods.

2

Fig 1

Fig 2

ArCom™

Polyethylene*

Volu

met

ric W

ear R

ate

mm

3 /106 C

ycle

s

Small Diameter Volumetric Wear1

5 million cycles on a hip simulator28mm head size

ArComXL™ E1™0

10

20

30

40

50

60

53.3

29.4

0.24

E1 Tapered Liners

Design Rationale

Tri-Bearing Options

The Exceed-ABT acetabular system is a highly versatile multi-bearing platform capable of addressing the needs of both primary and revision hip surgery. The facility to select intra-operatively between C2A-Delta (ceramic), M2A (CoCr) and E1 large diameter bearings optimises implant function in line with clinical requirements and patient activity.

M2A Metal LinerC2A Ceramic Liner E1 Standard Liner E1 High-Wall Liner E1 10˚ Liner

Standard TaperFit Shell

15° TaperFit Shell

Multi-Hole Shell

3-Hole Shell

Exceed ABT TaperFit Exceed ABT Ringloc-X

E1 Liner

C2A Ceramic Head M2A CoCrMo Head

3

Design Rationale

Fig 3

E1 Tapered Liners

Easier Revisions

The straightforward replacement of cobalt chromium or Biolox Delta ceramic liners with the E1 tapered liners makes revision cases easier, eliminating the need for an acetabular cup replacement. In addition, the 10-degree E1 Liner can be an ideal revision option should the acetabular cup be too vertically positioned.

Reduced Cup Inventory

If they wish, surgeons willing to use a soft bearing liner can use the Exceed-ABT Taperfit cup instead of the Exceed-ABT Ringloc- X Cup. The E1 line extension will permit hospitals to reduce their Exceed-ABT cup inventory, without having to compromise their choice of optimal bearing options for their patients.

Maximised Bearing Diameter

E1 tapered liners are made with E1 polyethylene inserts pressed into 1.5mm thick titanium tapered sleeves. A built-in offset (Fig 3) helps maximise the bearing diameter (28, 32, 36mm) without compromising the minimum polyethylene thickness (5.7mm minimum nominal thickness), and therefore without compromising the polyethylene mechanical properties.

4

Fig 3

Thick

ness

45°

Design Rationale

E1 Tapered Liners

Optimal Mobility and Limited Risk of Dislocation

The E1 tapered liners have been developed to maximise the patient range of motion (Fig 4). The most critical head/liner/stem implant combinations have been tested and fully satisfy the range of motion performance requirements4.

The range of motion has been maximised whilst preserving the femoral head coverage. Between 179 and 181 degrees of head coverage is achieved across the range5 in order to limit the risk of implant dislocation.

Stability

Like the Biolox delta ceramic and cobalt chromium liners, the titanium sleeve of the E1 tapered liners solidly locks into the shell thanks to the Ceralock taper interface, technology from Ceramtec.

The titanium sleeve has a circumferential retaining groove which prevents micro-motion of the inner E1 liners. The surface finish of the metal back combined with the tight press-fit of the inner E1 liner address risks of component rotation.

The E1 tapered liner underwent series of level-out, push-out and torsion-out mechanical tests. It has been demonstrated that the E1 tapered liner provides excellent resistance to mechanical forces and minimises the risk of polyethylene disengagement from its titanium sleeve6.

Fatigue Resistance

Rim impingement test (Fig 6) were carried-out by an independent institute. The 2 million cycle test unveiled the absence of cracks, deformation, delamination of the polyethylene subsequent to loading7.

Biolox® and Ceralock® are Ceramtec Brands

5

180° Internal/External Rotation 115° Abduction/Adduction Angle 135° Flexion/Extension Angle

Fig 4

Fig 5

Fig 6

E1 Tapered Liners

Design Rationale

Liner Options

The E1 tapered liners are available in bearing sizes 28, 32 and 36mm in standard and 10-degree configurations. The 10-degree liners address vertically positioned acetabular shells, and help restore the biomechanics of the hip. Compared with the standard liner, It provides an additional 10-degree inclination/version depending upon placement of the liner in the cup. The Femoral head is therefore lateralised in comparison to the standard E1 tapered liners (Fig 7). The 10-degree liner has a radiolucent pin to check the correct rotational position of the liner inside the acetabular shell.

Note: The 10-degree liner cannot be used in conjunction with the Exceed ABT Taperfit 15-degree shell.

6

Standard E1 Tapered Liner

10° E1 Tapered Liner

Fig 7

Additional Lateralisation

Size (mm)

E1 tapered Liners*

Ø28 Ø32 Ø36

Std 10° Std 10° Std 10°

Ø46E1-002837 E1-102837

Ø48

Ø50E1-003239 E1-103239

Ø52

Ø54E1-003644 E1-103644

Ø56

Ø58E1-003648 E1-103648

Ø60

Ø62

E1-003652 E1-103652

Ø64

Ø66

Ø68

Ø70

Ordering Information

Implants

Size (mm)

Standard TaperFit Shells

PC HA/PC BM/PC

Ø46 123746 123746HA 123746BM

Ø48 123748 123748HA 123748BM

Ø50 123950 123950HA 123950BM

Ø52 123952 123952HA 123952BM

Ø54 124454 124454HA 124454BM

Ø56 124456 124456HA 124456BM

Ø58 124858 124858HA 124858BM

Ø60 124860 124860HA 124860BM

Ø62 125262 125262HA 125262BM

Ø64 125264 125264HA 125264BM

Ø66 125266 125266HA 125266BM

Ø68 125268 125268HA 125268BM

Ø70 125270 125270HA 125270BM

Size (mm)

15 Degree TaperFit Shells

PC HA/PC BM/PC

Ø46 233746 233746HA 233746BM

Ø48 233748 233748HA 233748BM

Ø50 233950 233950HA 233950BM

Ø52 233952 233952HA 233952BM

Ø54 234454 234454HA 234454BM

Ø56 234456 234456HA 234456BM

Ø58 234858 234858HA 234858BM

Ø60 234860 234860HA 234860BM

Ø62 235262 235262HA 235262BM

Ø64 235264 235264HA 235264BM

Ø66 235266 235266HA 235266BM

Ø68 235268 235268HA 235268BM

Ø70 235270 235270HA 235270BM

Exceed ABT Taperfit Acetabular Components

7

*The colours correspond to those on the shell, liner labels and related trial liners.

*The colours correspond to those on the shell and liner labels.

ProductProduct DescriptionDescription Order CodeOrder Code

1 Exceed-ABT E1 Tapered Trial Liners Complete Set E1-100000E1-100000

1 Exceed-ABT E1 Tapered Trial Liners Empty Case E1-100001E1-100001

1 E1 Tapered Trial Liner 0° - 28/37 E1-002837TE1-002837T

1 E1 Tapered Trial Liner 0° - 32/39 E1-002839TE1-002839T

1 E1 Tapered Trial Liner 0° - 36/44 E1-003644TE1-003644T

1 E1 Tapered Trial Liner 0° - 36/48 E1-003648TE1-003648T

1 E1 Tapered Trial Liner 0° - 36/52 E1-003652TE1-003652T

1 E1 Tapered Trial Liner 10° - 28/37 E1-102837TE1-102837T

1 E1 Tapered Trial Liner 10° - 32/39 E1-103239TE1-103239T

1 E1 Tapered Trial Liner 10° - 36/44 E1-103644TE1-103644T

1 E1 Tapered Trial Liner 10° - 36/48 E1-103648TE1-103648T

1 E1 Tapered Trial Liner 10° - 36/52 E1-103652TE1-103652T

Ordering Information

Instruments

8

9

1. Data on file at Biomet. Bench test results not necessarily indicative of clinical performance.

2. Wannomae, K. Environmental Stress Cracking of Two-Tocopherol Doped, Irradiated UHMWPEs and Two Contemporary UHMWPEs. Report Provided by the Orthopaedic Biomechanics and Biomaterials Laboratory at Massachusetts General Hospital. January 12, 2007.

3. Bhambri S., et al. The effect of aging on mechanical properties of melt-annealed highly crosslinked UHMWPE. Crosslinked and Thermally Treated Ultra-High Molecular Weight Polyethylene for Joint Replacements. 171-82, 2004.2004

4. Data on file at Biomet; Report “E1 tapered Ensayo Rango Movimiento Angular” 200804

5. Data on file at Biomet; Report “E1 tapered Head coverage angle” 200804

6. Data on file at Biomet; Report “E1 tapered Level-out, Push-out, torsional test” LE-061SO/

7. Data on file at Biomet: Report “E1 tapered liner Rim Impingement test” Instituto de Biomecanica de Valencia

References

Notes

10

Notes

11