One Surgeon. One Patient. FLH /11

Transcription

1 FLH /11 This publication has been issued by: European Central Marketing Waterton Industrial Estate Bridgend South Wales CF31 3XA +44 [0] [0] Responsible Manufacturer: Biomet Spain Orthopaedics S.L. P.O. Box 96 Calle Islas Baleares Fuente del Jarro Valencia Spain One Surgeon. One Patient.

2 E1 Tapered Liners Design Rationale

3 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.

4 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

5 E1 Tapered Liners Design Rationale 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. 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) Volumetric Wear Rate mm 3 /10 6 Cycles Clean Conditions Volumetric Wear 5 million cycles on a hip simulator 36mm and 40mm head size 55.4 Fig Abrasive Conditions 40mm E1 36mm ArCom* Fatigue strength greater than first generation re-melted HXLPE 1,2,3 Stronger than sequentially crosslinked and annealed materials after an environmental stress cracking (ESC) study Small Diameter Volumetric Wear 1 5 million cycles on a hip simulator 28mm head size 53.3 True oxidative protection without re-melting: no evidence of measurable oxidation 1 Volumetric Wear Rate mm 3 /10 6 Cycles ArCom Polyethylene* ArComXL 0.24 E1 2 Fig 2

6 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. Exceed ABT TaperFit Exceed ABT Ringloc-X Standard TaperFit Shell 15 TaperFit Shell 3-Hole Shell Multi-Hole Shell C2A Ceramic Liner E1 Liner M2A Metal Liner E1 Standard Liner E1 High-Wall Liner E1 10 Liner C2A Ceramic Head M2A CoCrMo Head 3

7 E1 Tapered Liners Design Rationale 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. Fig 3 Fig 3 45 Thickness 4

8 E1 Tapered Liners Design Rationale 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 requirements Internal/External Rotation 115 Abduction/Adduction Angle 135 Flexion/Extension Angle 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 range 5 in order to limit the risk of implant dislocation. Stability Fig 4 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. Fig 5 The E1 tapered liner underwent series of levelout, 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 sleeve 6. 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 loading 7. Fig 6 Biolox and Ceralock are Ceramtec Brands 5

9 E1 Tapered Liners Design Rationale Liner Options Additional Lateralisation 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. Standard E1 Tapered Liner 10 E1 Tapered Liner Fig 7 6

10 Ordering Information Implants Size (mm) Ø46 Ø48 Ø50 Ø52 Ø54 Ø56 Ø58 Ø60 Ø62 Ø64 Ø66 Ø68 Ø70 E1 tapered Liners* Ø28 Ø32 Ø36 Std 10 Std 10 Std 10 E E E E E E E E E E *The colours correspond to those on the shell, liner labels and related trial liners. Exceed ABT Taperfit Acetabular Components Size (mm) Standard TaperFit Shells PC HA/PC BM/PC Size (mm) 15 Degree TaperFit Shells PC HA/PC BM/PC Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM Ø HA BM *The colours correspond to those on the shell and liner labels. 7

11 Ordering Information Instruments Product Description Order Code 1 Exceed-ABT E1 Tapered Trial Liners Complete Set E Exceed-ABT E1 Tapered Trial Liners Empty Case E E1 Tapered Trial Liner 0-28/37 E T 1 E1 Tapered Trial Liner 0-32/39 E T 1 E1 Tapered Trial Liner 0-36/44 E T 1 E1 Tapered Trial Liner 0-36/48 E T 1 E1 Tapered Trial Liner 0-36/52 E T 1 E1 Tapered Trial Liner 10-28/37 E T 1 E1 Tapered Trial Liner 10-32/39 E T 1 E1 Tapered Trial Liner 10-36/44 E T 1 E1 Tapered Trial Liner 10-36/48 E T 1 E1 Tapered Trial Liner 10-36/52 E T 8

12 References 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, 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 , Data on file at Biomet; Report E1 tapered Ensayo Rango Movimiento Angular Data on file at Biomet; Report E1 tapered Head coverage angle 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 9

13 10 Notes

14 Notes 11

15

16