bi-metric porous primary hip system: the cornerstone of the alliance hip system family

Bi-metric porous primary hip system

alliance X-Series implant technology

Femoral Neck: Unchanged since 1984, a standard Morse-type taper with reduced AP neck dimensions facilitates range of motion up to 154. Adapts to seven neck lengths and accommodates a range of head sizes: 22mm, 26mm, 28mm, 32mm and the 38mm metal-on-metal. Insertion Hole: Medialized for ease of insertion and less interference from the greater trochanter.

Porous Coating: A titanium alloy substrate combined with non-interconnected, circumferential titanium porous coating has been designed for bony ingrowth to lock in the femoral implant and create a seal to particulate debris migration that may help to reduce osteolysis and improve long-term xation.8

Interlok Surface: Provides a roughened titanium surface for bone ongrowth, enhancing the potential for long-term xation.

Titanium: The porous hips of the Alliance X-Series are constructed of Ti-6Al-4V titanium alloy to enhance bio-compatability, high fatigue strength and a low modulus of elasticity.

Tapered Feature: Biomets philosophy incorporates a clinically proven 3 bi-planar taper geometry. The stem tapers 3 from the proximal shoulder to the distal tip of the implant and from the lateral shoulder to the medial calcar area. The taper affords greater proximal stress off-loading and minimizes the need to remove distal cortical bone. Each implants distinct lateral-to-medial taper is designed to provide physiologic proximal load transfer and exceptional implant-to-patient t.
Introducing the new Bi-Metric Lateralized Primary Stem

biomet, the rst company to establish the standard for success. Titanium

FEATURES & BENEFITS OF ALLIANCE X-SERIES IMPLANTS:

Simple Standard Instrument Sets: Incorporating one common set of instruments, the Exact hip instruments are used to implant all Alliance X-Series components (Figure 1). This feature provides the surgeon with maximum exibility and simplies procedures for the OR staff while reducing instrument inventory for the hospital. Alliance X-Series Surface Coatings: The X-Series implants offer a variety of surface nishes that promote xation. Biomets porous plasma sprayed components have shown signicantly lower rates of osteolysis than other circumferentially-coated components.8,11,12,15,17 Proximal circumferential non-interconnected plasma spray works in conjunction with the implant design for optimal bone ingrowth. A roughened Interlok nish provides the medium for bone ongrowth and the smooth or polished portions of the stem is consistent with proximal xation. Net-Forgings:

bi-planar taper geometry circumferential plasma spray porous coating

Net-forging technology provides a more precise t for the implant. Figure 1 Alliance General Case I The human variability associated with hand polishing is reduced, allowing superior reproduction of the compound angles on the nished implant. In addition, net-forgings adhere to the industrys most exacting dimension tolerances, which provide a more consistent broach-to-implant t.

unchanged philosophy: titanium, tapered geometry, & plasma spray.

alliance X-Series implant technology

the X-Series of implants blends biomet tradition and advanced technology.

TRADITION AND TECHNOLOGY

The Alliance family of femoral components uses net-shape forgings and advanced manufacturing technology to optimize the consistency of multiple geometries and congurations. The foundation for the X-Series of implants are the excellent long-term clinical results of proximal-to-distal tapered stem geometries (Figure 1). The combined technology and geometries have proven to meet the needs of both the patient and the surgeon for successful cementless hip reconstruction. Meticulous design and superior materials, combined with improved manufacturing techniques, have allowed for advanced concepts in femoral components and instrumentation. Net-shape forging technology results in a consistent and reproducible surgical technique. This advanced technology provides a more precise envelope for Figure 1 The Bi-Metric Porous hip system is the foundation of the technologically advanced X-Series femoral components. the implant, which has greatly reduced the human variability associated with previous manufacturing methods. This technology has been integral in the development of superior standards of performance. The X-Series implants maximize the effectiveness of net-forging technology while maintaining the specic features that surgeons prefer.

uncompromised tradition & technology.

The X-Series implants are manufactured using three-dimensional CAD-CAM techniques. Computer-aided design (CAD) and computer-aided manufacturing (CAM) have revolutionized the manufacturing process (Figure 2). 3D CAD-CAM engineering technology is superior over previous 2D CAD-CAM designs in that 2D technology allowed for two-dimensional drawings to be designed in limited planes. Due to this limited technology, there was a possibility for variability in the nal design. New, innovative processes permit creation of the actual implant, while eliminating manufacturing steps (Figures 3 and 4). Figure 2 Innovative computer-aided design (CAD) Recent developments in three-dimensional solid modeling technology allow for designs to be viewed and manipulated from all angles. This technology provides accurate interpretation of compound planes and complex implant geometries, leading to the precise and consistent development of femoral components and related instrumentation (Figure 5).

Figure 3 Shown above (left to right) are the near net-forging, turned taper, polished implant prior to porous coating, and the nal implant.

Figure 4 Shown above (left to right) are the net-forging, turned taper, and the nal implant.

Figure 5 Using the latest 3D CAD-CAM technology and machinery, Biomet engineers have successfully reduced tolerance issues as they relate to the broach and implant.

alliance X-Series implant technology

80 70
Fatigue Strength (ksi) at 107 Cycles

Range of values determined Range of values reported

60 50 40 30

TITANIUM PLASMA SPRAY

Plasma spray is a three-dimensional distribution of 20 randomly dispersed titanium particles (Figure 1). Biomets 10 Figure 1 Above is an SEM photograph proprietary plasma spray application is unique in that only 0 Plasma Sintered or Plasma Sintered or at 100x magnication showing the titanium alloy powder used to create the coating is Sprayed Diffusion Sprayed Diffusion plasma spray porous coating. Bonded Bonded heated, not the implants substrate. Plasma spray porous Ti Alloy Co-Cr Alloy coating is applied to the substrate of the implant at a low temperature, which preserves up to Figure 2 Effect of the porous coating method on fatigue 90% of the mechanical strength of the implant.2 Randomly shaped particles are attened strength.8 upon impact with the substrate. An arbitrary distribution of pore size between 100 and 1,000 microns is generated, providing a larger contact area between the particles and the substrate. The resulting surface is rough in contrast to the smooth surfaces of a beaded implant. Implant stability, interface strength and contact to the bony surface area are maximized by the irregular surface. This feature allows the implant to scrape bone into the pores during implantation, providing solid initial xation. In addition, the random particle dimensions result in a varied pore size distribution. Smaller pores are important for initial xation because they quickly ll in with bone, promoting early osseointegration. Larger pores require a longer time to ll in

POROUS COATING VS. OSTEOLYSIS

Author
Evans and DeLee Mauerhan, et al. McLaughlin Head, et al. Rothman Bourne, et al. Multi-Center Study Meding, et al. Capello, McClain Heekin, et al. Woolson, Maloney Kim, et al. Kim, et al. Smith, Harris Engh Kim, et al.

Reference
Submitted for Publication J. Arthroplasty, 1997 JBJS Orthopedics, 1999 Orthopedics, 1994 Hip Society (March), 2001 Biomet Clinical Report, 1994 AAOS (Feb.), 2001 Trans. Intl Sym., 1992 JBJS, 1993 J. Arthroplasty, 1992 Orthop. Trans, 19923 Orthop. Trans, 19923 CORR, 1995 Presentation, 1992 CORR, 1999

Hip Implant System

Bi-Metric (Biomet) Integral (Biomet) Taperloc (Biomet) Mallory-Head (Biomet) Taperloc (Biomet) Mallory-Head (Biomet) Taperloc, Mallory-Head Bi-Metric, Integral (Biomet) Bi-Metric (Biomet) Omnit (Osteonics) PCA (Howmedica) Harris/Galante (Zimmer) PCA (Howmedica) AML (DePuy) Harris/Galante (Zimmer) AML (DePuy) AML (DePuy)

Years Followed
510 years 58 years 812.5 years 11 years avg. 7 years 1013 years 5 years 1012 years 26 years 57 years 3.5 yrs. avg. follow-up 27 years 27 years 4.5 yrs. avg. follow-up 7.5 yrs. avg. follow-up 11.3 yrs. follow-up

Osteolysis
0.0% 0.0% 6.0% 0.0% 3.0% 0.0% 0.4% 0.0% 44.7% 18.0% 22.0% 37.0% 55.8% 31.0% 28.0% 17.0%

and provide for long-term xation with continued macro bone in-growth. Bony in-growth is important for mechanical interlocking and maximum load transfer. Studies show that rough titanium has been found to have a good propensity for encouraging adhesion of osteoblasts. 18 Circumferentially coating the femoral component with plasma spray creates a barrier to particulate debris (metallic, polyethylene or PMMA), which can trigger a macrophage response that can initiate osteolysis.1,5,9,14 Tanzer, et al., have reported that sealing the endosteum from the pumping of debris may be the most important factor in preventing osteolysis in total hip patients.19 The lack of longitudinal pore interconnectivity creates a seal from this particulate debris migration, which may help to reduce osteolysis anatomic offsets and improve long-term xation.7,19 While other femoral components have enhance joint stability circumferential porous coating, it is not Biomets clinically proven and help restore hip non-interconnected plasma spray.3,7,13
biomechanics by providing the opportunity to tighten

LATERAL OFFSET RESTORATION

soft tissue without creating leg length

In total hip reconstruction, the most effective and easily manipulated discrepancies. mechanical variable available to the surgeon to optimize the biomechanics of the hip is the offset of the prosthesis. A lateral offset option allows the surgeon to enhance joint stability and restore normal hip function. If the potential offset deciency is not identied or treated, it could lead to joint instability, limp, and increased joint reaction forces. The advantage, intra-operatively, is that it allows for adjustment of offset and soft tissue tension without changing the neck resection level or the length of the leg. The X-Series implants employ two methods of achieving optimal offset restoration. For the Integral femoral stems, lateralization is achieved by shifting the neck geometry of the implant medially 6mm while maintaining a constant neck shaft angle and slightly increasing the length of the taper. The Bi-Metric X-Series addresses lateral offset by lowering the neck angle, slightly increasing the length of the trunion, and shifting the neck geometry medially in proportion to the stem size (Figure 3).

Figure 3 The Alliance X-Series implants offer two distinctive design strategies for restoration of lateral offset.

bi-metric porous primary hip x-series system

Bi-Metric HIP stem: Uncompromising design uniquely functional reported Long-term clinical success

BI-METRIC HIP SYSTEM

Since its introduction in 1984, the Bi-Metric Hip System continues to provide a high degree of versatility and unsurpassed clinical performance. Developed by a team of orthopedic surgeons and engineers, the Bi-Metric hip stems major design concept of a 3 bi-planar taper is incorporated throughout nearly every Biomet hip system. The bi-planar taper and distinct lateral-to-medial taper provide physiologic proximal load transfer and preserve distal cortical bone, signicantly reducing the likelihood of proximal resorption.

Figure 1 Medialized Insertion Hole

Exact Alliance Instrumentation for intraoperative exibility. Medialization of the insertion hole facilitates implant insertion without interference of the greater trochanter (Figure 1).

KEY DESIGN FEATURES:

3 Bi-planar taper provides enhanced proximal stress off-loading and initial implant stability. Forged titanium for better biocompatibility and a lower modulus of elasticity for enhanced load transfer. Manufactured with state-of the-art solid modeling and net-shaped forgings. The titanium plasma spray porous coatings structure acts as a potential barrier to the migration of particulate debris and provides rotational stability and proven long-term xation. Seven neck lengths allow for accurate leg length adjustment. Available in collared and collarless designs. Lateralized option available for proper joint restoration.

Primary Results at 1012 year follow-up/ 100% survivorship in 105 hips17 No Osteolysis HHS Increased from an Average of 26 Preoperatively to 92 Postoperatively No Revisions 811 year follow-up/ 100% Aseptic Survivorship in 67 hips10 3% Thigh Pain 1.5% Osteolysis No Revisions for Aseptic Loosening 515 year follow-up of 118 hips6 No Osteolysis No Thigh Pain 100% Survivorship

CASE STUDY:
Preoperative Patient was a 61-year old man who had long standing bilateral hip arthritis that severely limited his activities.

LATERAL OFFSET RESTORATION:

The collarless Bi-Metric Primary Porous Hip is available in a standard and lateralized offset. In-depth studies have concluded that femurs with greater horizontal offset often have a more varus neck shaft angle. As the stem size increases, the required offset also increases.4 The Bi-Metric lateralized components design is based on this philosophy. The offset is achieved by decreasing the neck shaft angle, medially shifting the trunion and increasing the neck length, while not affecting leg length (Figure 2). All of these key features work in unison to promote gradual off-loading of stresses from the femoral component throughout the entire femur (Figure 3).

9mm 7mm 5mm

Immediate Postoperative A/P X-ray of a Bi-Metric collarless component.

6mm

Lat. Neck Angle 130.0

Std. Neck Angle 135.0

8-Year Postoperative At 8-year follow-up the patient is pain free, walking 2 miles per day and doing 20 ights of stairs per day without difculty. Range of motion and gait are normal. Follow-up X-rays at 8-years show no osteolysis or component subsidence. Proximal bone quality is excellent.

Figure 2 Bi-Metric Standard and Lateral Offset Stems

Bi-Metric Lateralized Offset References Stem Size Porous 810mm 1114mm 1517mm Figure 3 Additional Lateralized Offset 5mm 7mm 9mm

Alliance X-Series/ exact instrumentation experience

exact hip instrumentation offers versatility, simplicity, and intraoperative exibility by providing a common general instrument case used in combination with the Alliance system-specic instrumentation.

INSTRUMENTATION

Figure 1 Alliance Reamer and Broach Cases

The Exact Hip Instrumentation was designed for improved efciency in the OR. The system includes precision instrument designs that promote accuracy, provide reproducible results, and complement Biomets clinically proven femoral components. Alliance femoral components can be implanted using only three trays: the General I Insertion case and the Alliance system-specic Reamer and Broach cases (Figure 1). The broach cases can accommodate up to 12 different neck trunions to support any Alliance implant. Recognizable color-coding identies the instrumentation specic to the selected femoral component.

The following Exact Hip Instrumentation cases are needed to implant the Alliance Family femoral components:

KEY COMPONENTS OF THE EXACT INSTRUMENTATION ARE:

A Starter Reamer allows for the initial opening of the femoral canal. The Offset Chisel provides a direct view for accessing the piriformis fossa.

General Case 1

Alliance Reamers

Alliance Broaches

Incrementally sized Magnetic Trial Necks in standard and lateralized offsets offer accurate intraoperative biomechanical adjustment during trial reduction. Standard offset is gold while lateralized offset trial necks are black. System-Specic Reamers with new markings that reference both the greater trochanter and medial resection level.

General Case II (Extraction) Open only if needed

Cylindrical Reamers Optional

The Femoral Inserter facilitates implant insertion. The Alliance Femoral Resection Guide offers the versatility of medial and vertical radius reference points from the greater and lesser trochanter respectively (Figure 2). A convenient trochanter stop assists in accurate measurement. The Broach Handle provides solid engagement with a quick, easy trigger locking mechanism that affords a clear view and a rapid release. A large impaction plate provides for solid driving contact. Broaches provide efcient removal of cancellous bone to contour a precise envelope for the femoral component. These newly designed broaches are created utilizing the same data set used to produce the implant. An innovative cutting tooth design and nitrided surfaces provide for durability and prolonged life of the cutting edges.

Figure 2 Alliance Resection Guide and Reamer. Vertical markings on the Alliance Resection Guide correspond to markings on the Alliance Reamers for consistent, reproducible results.

X-RAY TEMPLATES: PREOPERATIVE PLANNING

The new Exact Template system offers a precise technique for implant sizing and preoperative evaluation of anatomic offset (Figure 3). Vertical and medial scales correspond to the resection guide to aid in leg length restoration. The templates are designed to match the color-coded instrument case for ease of identication and offer a table for quick offset references (Figure 4).

Figure 3 Preoperative x-ray with new Bi-Metric Hip Template

Figure 4 Bi-Metric Hip Template

bi-metric primary hip x-series surgical technique

the bi-metric femoral component combines unmatched clinical success with new, innovative instrument design.

FEMORAL HEAD RESECTION

Using the Exact templates, determine the height of the femoral neck resection above the lesser trochanter and the height of the tip of the greater trochanter relative to the shoulder of the femoral component. The Alliance femoral neck resection guide references these measurements intraoperatively. Position the femoral neck resection guide parallel to the longitudinal axis of the femoral shaft. Conrm the height of the femoral neck resection above the lesser trochanter using the scale on the medial aspect of the resection guide relative to the preoperative templated X-ray. The vertical scale referenced to the greater trochanter is an additional conformation of the resection level (Figure 1). Resect the femoral neck at this level to re-create the appropriate femoral neck length and offset.

Fig. 1

ACCESSING FEMORAL CANAL

The Exact Offset Chisel is used to access the piriformis fossa and to clear a channel to accept the tapered reamers. The design provides for adequate visualization for a lateral pathway to avoid varus positioning (Figure 2). A Starter Reamer on a T-handle may be used to identify the femoral canal (Figure 3).

Fig. 2

Fig. 3

10

REAMING FEMORAL CANAL

The Alliance Exact Reamers are proportionally sized tapered reamers with blunt tips that are used to progressively enlarge the intramedullary canal to the size estimated by preoperative templating. In determining reamer depth, the proximal tip of the greater trochanter is used as a landmark to reference the femoral head center in conjunction with the reference bands on the reamer shaft, femoral resection guide, and the Exact Templates (Figure 4). Bands along the reamer shank reference the vertical scale on the templates and the resection guide, which correspond to the center of the femoral head (Figure 5). For example, if the templated vertical scale is a 10, bury the reamer until the 10mm mark on the reamer corresponds to the top of the greater trochanter for accurate femoral depth. Begin with a canal reamer that is 34mm smaller than the templated femoral component. Sequentially ream the femoral canal until cortical chatter is encountered. It is important to stay lateral and posterior with the femoral reamers to ensure that the canal is being prepared in neutral alignment with the femoral axis (Figure 6). Note: It is important to be lateral in the greater trochanter when broaching and reaming. A trochanteric reamer (Part No. 31-473192) is available to give additional lateralization if necessary.

Fig. 5 Fig. 4

Fig. 6

BROACHING PROXIMAL FEMUR

Begin the broaching process with a broach at least 23mm smaller than the largest reamer used. Attach the broach handle to the broach by pulling back on the trigger and locking it into place. It is important that the broach is oriented to produce the desired femoral anteversion. Sequentially increase the size of the broach until the templated size is reached or until the broach engages the medial cortex and can not be placed deeper (Figure 7). With the properly sized broach in place, the calcar can be planed ush by using the retractable calcar planer if necessary. The calcar planer is specially designed to reach the short broach post and prevent metal-to-metal wear of the post (Figure 8).

Fig. 7

Fig. 8

11

bi-metric primary hip x-series surgical technique

TRIAL REDUCTION
To perform the trial reduction with the nal broach still in place, attach the appropriate Exact Alliance magnetic neck trunion over the extended broach post. The gold trunion indicates standard offset, while the black trunion represents lateralized offset. The Exact magnetic trunions are sized to correspond to the appropriate broach size with the stem size clearly marked on top of the trunion (Figure 9). Select the trial femoral head of desired diameter and neck length (If using a collared trial, the collar should rest on the proximal femoral neck) (Figure 10). Reduce the hip to ensure that proper leg length and joint stability have been achieved. In performing the trial range of motion, ensure the absence of impingement of the femoral neck on the rim of the acetabular component or acetabular liner.
Fig. 9
Bi-Metric Trunions: Non-Collared and Collared Standard gold Non-Collared Lateralized black

INSERTING POROUS IMPLANT

The stem corresponding to the size of the nal broach is threaded onto the femoral stem inserter. The femoral inserter handle assists in controlling rotation of the implant and allows the implant to be placed into the femoral envelope with the proper amount of anteversion (Figure 11). The stem should slide distally into the canal without much resistance until the stem is 510mm proximal to the calcar. As resistance is met, gently tap the inserter until the implant is seated. If desired, another trial reduction can be accomplished prior to impacting the modular head onto the stem. Provisional heads in seven neck lengths allow an additional trial reduction using the actual implant to ensure proper leg length and stability. After fully seating the femoral component, the appropriate modular head is impacted onto the clean, dry taper (Figure 12).

Fig. 10

This brochure demonstrates the surgical technique of John Cuckler, M.D., Professor and Director, Division of Orthopedic Surgery, University of Alabama at Birmingham, Birmingham, Alabama, and Douglas E. Jessup, M.D., Richmond, Virginia. Biomet as the manufacturer of this device, does not practice medicine and does not recommend this or any other surgical technique for use on a specic patient. The surgeon who performs any implant procedure is responsible for determining and utilizing the appropriate techniques for implanting the prosthesis in each individual patient. Biomet is not responsible for selection of the appropriate surgical technique to be utilized for an individual patient.

Fig. 11

Fig. 12

12

SURGEON NOTES

HEAD OPTIONS

-5mm

-3mm

Std.

-6mm

-3mm

Std.

+3mm

+6mm

+9mm

+12mm

-3mm

Std.

-5mm

-3mm

Std.

+3mm

+6mm

13

ordering information

BI-METRIC FEMORAL COMPONENT

Stem Size 7mm 8mm 9mm 10mm 11mm 12mm 13mm 14mm 15mm 16mm 17mm 18mm 19mm 20mm 21mm Stem Length 115 120 125 130 135 140 145 150 155 160 165 170 175 180 185 Implant Std. Non-Collared X180307 X180308 X180309 X180310 X180311 X180312 X180313 X180314 X180315 X180316 X180317 X180318 X180319 X180320 X180321 Implant Lat. Non-Collared X11-180308 X11-180309 X11-180310 X11-180311 X11-180312 X11-180313 X11-180314 X11-180315 X11-180316 X11-180317 X11-180318 X11-180319 X11-180320 X11-180321 Implant Std. Collared X181307 X181308 X181309 X181310 X181311 X181312 X181313 X181314 X181315 X181316 X181317 X181318 X181319 X181320 X181321 Exact Alliance Broach 31-400007 31-400008 31-400009 31-400010 31-400011 31-400012 31-400013 31-400014 31-400015 31-400016 31-400017 31-400018 31-400019 31-400020 31-400021 Exact Alliance Tapered Reamer 31-400027 31-400028 31-400029 31-400030 31-400031 31-400032 31-400033 31-400034 31-400035 31-400036 31-400037 31-400038 31-400039 31-400040 31-400041

Neck Angle Bi-Metric Non-Collared Standard: 135 Neck Angle Bi-Metric Non-Collared Lateralized: 130 Neck Angle Bi-Metric Collared: 140

14

BI-METRIC NON-COLLARED MAGNETIC NECK TRUNIONS

Standard (Gold) Sizes 710 1114 1521 Part No. 31-400048 31-400049 31-400050 Lateralized (Black) Sizes 810 1114 1521 Part No. 31-400160 31-400161 31-400162

BI-METRIC COLLARED MAGNETIC NECK TRUNIONS

Sizes 710 1114 1521 Part No. 31-400045 31-400046 31-400047

Exact Instrument Cases: Exact General Case I 595100 Exact General Case II 595101 Alliance Specic Cases: Exact Alliance Broach Case 595105 Exact Alliance Tapered Reamer Case 595106 Bi-Metric Templates: Exact Bi-Metric Template Non-Collared 31-400163 Exact Bi-Metric Template Collared 31-400165

15

offset information
STANDARD COLLARED BI-METRIC POROUS PRIMARY
Size
7mm 8mm 9mm 10mm 11mm 12mm 13mm 14mm 15mm 16mm 17mm 18mm 19mm 20mm 21mm

Stem Length
115mm 120mm 125mm 130mm 135mm 140mm 145mm 150mm 155mm 160mm 165mm 170mm 175mm 180mm 185mm

Neck Angle
-6 140 140 140 140 140 140 140 140 140 140 140 140 140 140 140

Horizontal Offset
-3 STD +3 +6 +9 +12 -6

Vertical Offset
-3 STD +3 +6 +9 +12 -6

Neck Length
-3 STD +3 +6 +9 +12

35.1 37.1 39.0 40.9 42.9 44.8 46.7 26.6 28.9 31.2 33.5 35.8 38.1 40.4 28.4 31.4 34.4 37.4 40.4 43.4 46.4 35.4 37.4 39.3 41.2 43.2 45.1 47.0 26.7 29.0 31.3 33.6 35.9 38.2 40.5 28.4 31.4 34.4 37.4 40.4 43.4 46.4 35.7 37.7 39.6 41.5 43.5 45.4 47.3 26.9 29.2 31.5 33.8 36.1 38.4 40.7 28.4 31.4 34.4 37.4 40.4 43.4 46.4 36.0 38.0 39.9 41.8 43.8 45.7 47.6 27.0 29.3 31.6 33.9 36.2 38.5 40.8 28.4 31.4 34.4 37.4 40.4 43.4 46.4 36.3 38.3 40.2 42.1 44.1 46.0 47.9 27.1 29.4 31.7 34.0 36.3 38.6 40.9 28.4 31.4 34.4 37.4 40.4 43.4 46.4 36.6 38.6 40.5 42.4 44.4 46.3 48.2 27.2 29.5 31.8 34.1 36.4 38.7 41.0 28.4 31.4 34.4 37.4 40.4 43.4 46.4 36.9 38.9 40.8 42.7 44.7 46.6 48.5 27.4 29.7 32.0 34.3 36.6 38.9 41.2 28.4 31.4 34.4 37.4 40.4 43.4 46.4 37.2 39.2 41.1 43.0 45.0 46.9 48.8 27.5 29.8 32.1 34.4 36.7 39.0 41.3 28.4 31.4 34.4 37.4 40.4 43.4 46.4 37.5 39.5 41.4 43.3 45.3 47.2 49.1 27.6 29.9 32.2 34.5 36.8 39.1 41.4 28.4 31.4 34.4 37.4 40.4 43.4 46.4 37.8 39.8 41.7 43.6 45.6 47.5 49.4 27.8 30.1 32.4 34.7 37.0 39.3 41.6 28.4 31.4 34.4 37.4 40.4 43.4 46.4 38.1 40.1 42.0 43.9 45.9 47.8 49.7 27.9 30.2 32.5 34.8 37.1 39.4 41.7 28.4 31.4 34.4 37.4 40.4 43.4 46.4 38.4 40.4 42.3 44.2 46.2 48.1 50.0 28.0 30.3 32.6 34.9 37.2 39.5 41.8 28.4 31.4 34.4 37.4 40.4 43.4 46.4 38.7 40.7 42.6 44.5 46.5 48.4 50.3 28.2 30.5 32.8 35.1 37.4 39.7 42.0 28.4 31.4 34.4 37.4 40.4 43.4 46.4 39.0 41.0 42.9 44.8 46.8 48.7 50.6 28.3 30.6 32.9 35.2 37.5 39.8 42.1 28.4 31.4 34.4 37.4 40.4 43.4 46.4 39.3 41.3 43.2 45.1 47.1 49.0 50.9 28.5 30.8 33.1 35.4 37.7 40.0 42.3 28.4 31.4 34.4 37.4 40.4 43.4 46.4

Femoral Offset

Hor izontal Offset

th

Ve r t i c a l O f f s e t

Neck Angle

16

STANDARD NON-COLLARED BI-METRIC POROUS PRIMARY

Size
7mm 8mm 9mm 10mm 11mm 12mm 13mm 14mm 15mm 16mm 17mm 18mm 19mm 20mm 21mm

Stem Length
115mm 120mm 125mm 130mm 135mm 140mm 145mm 150mm 155mm 160mm 165mm 170mm 175mm 180mm 185mm

Neck Angle
-6 135 135 135 135 135 135 135 135 135 135 135 135 135 135 135

Horizontal Offset
-3 STD +3 +6 +9 +12 -6

Vertical Offset
-3 STD +3 +6 +9 +12 -6

Neck Length
-3 STD +3 +6 +9 +12

34.8 36.9 39.0 41.1 43.2 45.4 47.5 27.0 29.1 31.2 33.3 35.5 37.6 39.7 28.8 31.8 34.8 37.8 40.8 43.8 46.8 35.1 37.2 39.3 41.4 43.5 45.7 47.8 27.1 29.2 31.3 33.4 35.6 37.7 39.8 28.8 31.8 34.8 37.8 40.8 43.8 46.8 35.4 37.5 39.6 41.7 43.8 46.0 48.1 27.2 29.3 31.5 33.6 35.7 37.8 39.9 28.8 31.8 34.8 37.8 40.8 43.8 46.8 35.7 37.8 39.9 42.0 44.1 46.3 48.4 27.3 29.4 31.6 33.7 35.8 37.9 40.0 28.8 31.8 34.8 37.8 40.8 43.8 46.8 36.0 38.1 40.2 42.3 44.4 46.6 48.7 27.5 29.6 31.7 33.8 36.0 38.1 40.2 28.8 31.8 34.8 37.8 40.8 43.8 46.8 36.3 38.4 40.5 42.6 44.7 46.9 49.0 27.6 29.7 31.8 33.9 36.1 38.2 40.3 28.8 31.8 34.8 37.8 40.8 43.8 46.8 36.6 38.7 40.8 42.9 45.0 47.2 49.3 27.7 29.8 32.0 34.1 36.2 38.3 40.4 28.8 31.8 34.8 37.8 40.8 43.8 46.8 36.9 39.0 41.1 43.2 45.3 47.5 49.6 27.8 30.0 32.1 34.2 36.3 38.4 40.6 28.8 31.8 34.8 37.8 40.8 43.8 46.8 37.2 39.3 41.4 43.5 45.6 47.8 49.9 28.0 30.1 32.2 34.3 36.5 38.6 40.7 28.8 31.8 34.8 37.8 40.8 43.8 46.8 37.5 39.6 41.7 43.8 45.9 48.1 50.2 28.1 30.2 32.4 34.5 36.6 38.7 40.8 28.8 31.8 34.8 37.8 40.8 43.8 46.8 37.8 39.9 42.0 44.1 46.2 48.4 50.5 28.3 30.4 32.5 34.6 36.7 38.9 41.0 28.8 31.8 34.8 37.8 40.8 43.8 46.8 38.1 40.2 42.3 44.4 46.5 48.7 50.8 28.4 30.5 32.6 34.8 36.9 39.0 41.1 28.8 31.8 34.8 37.8 40.8 43.8 46.8 38.4 40.5 42.6 44.7 46.8 49.0 51.1 28.5 30.7 32.8 34.9 37.0 39.1 41.3 28.8 31.8 34.8 37.8 40.8 43.8 46.8 38.7 40.8 42.9 45.0 47.1 49.3 51.4 28.7 30.8 32.9 35.0 37.2 39.3 41.4 28.8 31.8 34.8 37.8 40.8 43.8 46.8 39.0 41.1 43.2 45.3 47.4 49.6 51.7 28.8 30.9 33.1 35.2 37.3 39.4 41.5 28.8 31.8 34.8 37.8 40.8 43.8 46.8

LATERALIZED NON-COLLARED BI-METRIC POROUS PRIMARY

Size
8mm 9mm 10mm 11mm 12mm 13mm 14mm 15mm 16mm 17mm 18mm 19mm 20mm 21mm

Stem Length
120mm 125mm 130mm 135mm 140mm 145mm 150mm 155mm 160mm 165mm 170mm 175mm 180mm 185mm

Neck Angle
-6 130 130 130 130 130 130 130 130 130 130 130 130 130 130

Horizontal Offset
-3 STD +3 +6 +9 +12 -6

Vertical Offset
-3 STD +3 +6 +9 +12 -6

Neck Length
-3 STD +3 +6 +9 +12

39.7 42.0 44.3 46.6 48.9 51.2 53.5 27.5 29.4 31.3 33.2 35.2 37.1 39.0 32.5 35.5 38.5 41.5 44.5 47.5 50.5 40.0 42.3 44.6 46.9 49.2 51.5 53.8 27.6 29.5 31.5 33.4 35.3 37.2 39.2 32.5 35.5 38.5 41.5 44.5 47.5 50.5 40.3 42.6 44.9 47.2 49.5 51.8 54.1 27.7 29.6 31.6 33.5 35.4 37.3 39.3 32.5 35.5 38.5 41.5 44.5 47.5 50.5 42.6 44.9 47.2 49.5 51.8 54.1 56.4 27.9 29.8 31.7 33.6 35.6 37.5 39.4 33.7 36.7 39.7 42.7 45.7 48.7 51.7 42.9 45.2 47.5 49.8 52.1 54.4 56.7 28.0 29.9 31.8 33.7 35.7 37.6 39.5 33.7 36.7 39.7 42.7 45.7 48.7 51.7 43.2 45.5 47.8 50.1 52.4 54.7 57.0 28.1 30.0 32.0 33.9 35.8 37.7 39.7 33.7 36.7 39.7 42.7 45.7 48.7 51.7 43.5 45.8 48.1 50.4 52.7 55.0 57.3 28.2 30.2 32.1 34.0 35.9 37.9 39.8 33.7 36.7 39.7 42.7 45.7 48.7 51.7 45.8 48.1 50.4 52.7 55.0 57.3 59.6 28.4 30.3 32.2 34.1 36.1 38.0 39.9 34.8 37.8 40.8 43.8 46.8 49.8 52.8 46.1 48.4 50.7 53.0 55.3 57.6 59.9 28.5 30.4 32.4 34.3 36.2 38.1 40.1 34.8 37.8 40.8 43.8 46.8 49.8 52.8 46.4 48.7 51.0 53.3 55.6 57.9 60.2 28.6 30.6 32.5 34.4 36.4 38.3 40.2 34.8 37.8 40.8 43.8 46.8 49.8 52.8 46.7 49.0 51.3 53.6 55.9 58.2 60.5 28.8 30.7 32.6 34.6 36.5 38.4 40.4 34.8 37.8 40.8 43.8 46.8 49.8 52.8 47.0 49.3 51.6 53.9 56.2 58.5 60.8 28.9 30.9 32.8 34.7 36.6 38.6 40.5 34.8 37.8 40.8 43.8 46.8 49.8 52.8 47.3 49.6 51.9 54.2 56.5 58.8 61.1 29.1 31.0 32.9 34.8 36.8 38.7 40.6 34.8 37.8 40.8 43.8 46.8 49.8 52.8 47.6 49.9 52.2 54.5 56.8 59.1 61.4 29.2 31.1 33.1 35.0 36.9 38.8 40.8 34.8 37.8 40.8 43.8 46.8 49.8 52.8

REFERENCES & ADDITIONAL SUPPORT MATERIAL

1. Anthony, P.; et al.: Localized Endosteal Bone Lysis in Relation to the Femoral Components of Cemented Total Hip Arthroplasties. J. Bone Joint Surg., B: 971979, November, 1990. 2. Bourne, R.B.; et al.: Ingrowth Surfaces: Plasma Spray Coating to Titanium Alloy Hip Replacements. CORR, 298: 3746, 1994. 3. Clinical Evaluation of Titanium Alloy Cementless Total Hip Replacement: A 15 Year Multi-Center Study. Biomet, Inc., Clinical Report, 1994. 4. Davey, J.R.; Tozakoglou, E.: The Role of Lateral Offset Stems. Orthop. Trans., 22(1): 273, 1999. 5. DeHeer; et al.: Differential Activation of Macrophages by Implant Wear Debris. Trans. Implant Retrieval Symposium of the Society for Biomaterials, 85, 1992. 6. Evans, J.: Outcome of a Tapered, Titanium, Proximal Load-Bearing NonCemented Femoral THA Component: A Minimum 5-Year Follow-Up Study. Presented at AAOS, New Orleans, LA, March 1923, 1998. 7. Head, W.C.: Mallory-Head Porous Press-Fit Primary Hip Replacement. Presented at the Tenth Annual International Symposium: New Developments in Total Joint Reconstruction, Lake Tahoe, Nevada, June 1416, 1993. 8. Head, W.C.; Mallory, T.H.; Emerson Jr., R.H.: The Proximal Porous Coating Alternative for Primary Total Hip Arthroplasty. Orthop., 22: 813, 1999. 9. Horowitz, S.; et al.: Microphage Exposure to Polymethyl Methacrylate Leads to Mediator Release and Injury. J. Orthop. Research, 9(3): 406413, 1991. 10. Jiranek, W.: The Bi-Metric Component at 811 Years. Presented at the 98 Harvard Hip Course. 11. Keisu, K.; Orozco, F.; Sharkey, P.; Hozack, W.; Rothman, R.: Primary Cementless Total Hip Arthroplasty in Octogenarians. J. Bone Joint Surg., 83-A: 359, 2001. 12. Mallory, T.H.: Minimum 10-Year Results of a Tapered Cementless Femoral Component in Total Hip Arthroplasty. Presented at Festschrift Celebration, May 2001to be published in J. Arthroplasty. 13. Mallory, T.H.; et al.: Clinical and Radiographic Outcome of a Cementless Titanium Plasma-Spray Coated Total Hip Arthroplasty Femoral Component: Justication for Continuance of Use. Presented at the Annual Meeting of the AAOS, Orlando, FL, February, 1995. 14. Maloney, W.; et al.: Fibroblastic Response to Particulate Metallic Debris. Trans. Implant Retrieval Symposium of the Society of Biomaterials, 34, 1992. 15. Mauerhan, D.R.; Mesa, J.; Gregory, A.; Mokris, J.: Integral Porous Femoral Stem 5 to 8 Year Follow-up Study. J. of Arthroplasty, 12(3): 250255, 1997. 16. McLaughlin, J.; Lee, K.: Total Hip Arthroplasty with an Uncemented Femoral Component. J. Bone Joint Surg., 79-B: 900907, 1997. 17. Meding, J.B.: Minimum Ten-Year Follow-Up of a Straight-Stemmed, PlasmaSprayed, Titanium-Alloy, Uncemented Femoral Component. Presented at AAOS, San Francisco, CA, February 28 March 4, 2001. 18. Symposium: Porous Coating Methods: The Pros and Cons. Contemporary Orthop., 27(3): 269296, 1993. 19. Tanzer, M.; et al.: The Progression of Femoral Cortical Osteolysis in Association with Total Hip Arthroplasty Without Cements. J. Bone Joint Surg., 74-A: March, 1992.

Alliance, Bi-Metric, Mallory-Head, Taperloc, Exact and Integral are trademarks of Biomet, Inc. All other trademarks are not associated with Biomet.

P.O. Box 587, Warsaw, IN 46581-0587 574.267.6639 2002 Biomet Orthopedics, Inc. All Rights Reserved web site: www.biomet.com eMail: [email protected] Form No. Y-BMT-761/053102/K