Cement and AccessoriesTraining ManualConfidential – For internal use only by Smith & Nephew employees and sales force. Do not publicly distribute.

The cement and accessories portfolioSmith & Nephew offers a full cement and accessories portfolio from bone cement to pulse lavage. To adequatelypromote and sell the cement and accessories portfolio, a thorough understanding of each product is required.Characteristics of bone cementBone cement comes in two parts:1. Powder, or the polymer2. Liquid, or the monomerOnce the powder and the liquid are mixed together, polymerization occurs andan exothermic reaction creates the final, hardened bone cement.The powder component typically consists of the following three materials: The polymer (in the form of one or a combination of the following)- PMMA – Polymethylmethacrylate- MMA/Styrene Copolymer – Methylmethacrylate/Styrene Copolymer- MMA/MA Copolymer – Methylmethacrylate/Methacrylate Copolymer Radiopacifier – Zirconium Oxide or Barium Sulfate Initiator – Benzoyl PeroxideThe liquid component typically consists of the following materials: MMA – Methylmethacrylate Initiator – N-Dimethyl-P-Toluidine Inhibitor/Stabilizer – HydroquinoneCompetitive S&N RALLY PMMABarium SulphateS&N VERSABOND PMMA MMA/MA copolymerZirconium DioxideTMMMA/MA copolymerZirconium DioxideTMPMMA MMA/Styrene copolymerZirconium DioxideBiomet Cobalt HVBiomet Cobalt MVTMDePuy CMWPMMABarium SulphateTMMMA/MA copolymerZirconium DioxideTMPMMA MMA/Styrene copolymerBarium SulphateTMPMMABarium SulphatePMMA MMA/Styrene copolymerBarium SulphateMMA/MA copolymerZirconium DioxideDePuy SmartSet HVDePuy SmartSet MVExactech CemexTMStryker Simplex PTMZimmer Palacos RImportant termsPolymer: Many molecules combined together to form chains or structuresMonomer: Single molecules that will combine with other molecules to form the polymer (the building blocks)Polymerization: A chemical reaction in which two or more molecules combine to form larger molecules orchains that contain repeating structural unitsExothermic reaction: A reaction/process that gives off heat as a product of the reactionRadiopacifier: Component that allows the substance to show up on an X-rayInitiator: Component that starts a chemical reactionInhibitor/Stabilizer: Prevents degradation or uncontrolled recombinations of the polymerConfidential – For internal use only by Smith & Nephew employees and sales force. Do not publicly distribute.

How does it work?PolymerizationPolymerization is the reaction that occurs when mixing the powder and the liquid components. The reactionbegins as soon as the liquid wets the powder. The liquid initiator (N-Dimethyl-p-Toluidine) reacts with thepowder initiator (Benzoyl Peroxide) and the monomer and polymer begin to polymerize (join together to createlonger chains) causing the mix to change into a doughy state. Polymerization continues unassisted via anexothermic reaction. Heat is released until the polymerization process is complete.The setting processThere are three aspects to the bone cement setting process. The dough time, or wait time, is the time fromwhen the cement is mixed until it no longer adheres to the moist surgical glove. The working phase, orhandling time, is the amount of time the cement is workable or implantable. Finally, the overall setting time isfrom the moment the powder and liquid components are mixed until the hardening phase is complete.The following are variables that can impact the amount of setting and handling time and must be consideredin surgery: OR Temperature – the warmer the temperature, the faster the cement sets and the shorter the handling time. Chilling the monomer and powder – the colder the temperature, the slower the cement sets. Cooling thecomponents slows the reaction. The reverse happens when the components are warmed. Chemical composition of the cement – the components of the cement and its inherent viscosity affectthe setting process. Every cement is different, and therefore, every cement requires an understandingof its own temperature vs time curves.Time vs temperature characteristics4Note: Lighter shades of blue, green and grey suggest /- 1 min tolerances. Phase tolerances may overlap.RALLY HV Bone CementRALLY HV AB Bone Cement75.075.0Mixing PhaseMixing Phase73.0Dough PhaseWorking Phase71.0Setting Phase69.067.0Temperature ( F)Temperature ( F)73.065.0Dough PhaseWorking Phase71.0Setting 71819 20012345678Time (min)77.09101112131415RALLY MV Bone Cement77.0171819 20RALLY MV AB Bone CementMixing PhaseMixing Phase75.075.073.0Working Phase71.0Setting Phase69.0Dough PhaseTemperature ( F)Dough PhaseTemperature ( F)16Time (min)73.0Working Phase71.0Setting 3141516171819 20012345678Time (min)910111213141516171819 20Time (min)Above bone cements were hand mixed.RALLY HV AB All-in-One SystemRALLY MV AB All-in-One System75.075.0Mixing PhaseMixing Phase73.0Dough PhaseWorking Phase71.0Setting Phase69.067.0Temperature ( F)Temperature ( F)73.0Setting Phase67. time (min)1213141516171819 20Working Phase69.063.00Dough Phase71.0012345678910111213141516171819 20Setting time (min)Above All-in-One Systems were not mixed under vacuum. Note: No dough phase is present as the cement is pre-contained in an injectable deviceand the surgeon decides when to begin dispensing cement.Confidential – For internal use only by Smith & Nephew employees and sales force. Do not publicly distribute.

ViscosityViscosity is the relative flow resistance of a material. The viscosity of bone cement affects its handlingcharacteristics, handling time, and penetration of the cement into the cancellous bone. There are threelevels of viscosity in bone cement. Low Viscosity (PalacosTM LV) – Very runny for a longer period of time, like milk. Medium Viscosity (VERSABOND , RALLY MV, Simplex P) – Initially more liquid, but sets up 5 – 8minutes faster than low viscosity, like pudding. High Viscosity (RALLY HV, PalacosTM R) – Reaches a dough state within the first few minutes of mixing,like PlayDoh .The features and benefits of RALLYRALLY is manufactured by Tecres, S.p.A in Verona, Italy. Tecres has 30 years of experience developing,manufacturing, and selling bone cement and accessory products. Smith & Nephew’s goal for RALLY wasto offer 2 different cement options – a cement that is doughy and sets quickly conducive to TKA and acement that takes longer to set up conducive to injecting cement. This further enables Smith & Nephewto offer a solution for more surgical scenarios. Bone cement is an intergral part of the long-term survival ofcemented TJA and the following features and benefits of RALLYcements should be noted:RALLY comes in two viscosities allowing for use in different totaljoint procedures.RALLY has a long-lasting spearmint green color for easyvisualization during surgery and in the event of anyrevision procedures.RALLY can be hand-mixed (HV and MV), vacuum-mixed (MV), ormixed and dispensed in a unique All-in-One system (HV and MV).The All-in-One system contains both the monomer and powderin one device, removes risk of contamination or broken glass,and is vacuum-compatible for decreased porosity.RALLY has lower porosity than competitive cements due to itspowder characteristics, even when hand-mixed.3,4 Bone cementporosity is caused by air bubble inclusions and is seen as thestarting point for fatigue fractures.5RALLY has shown excellent shear, tensile, and bending strengthscompared to competitive cements based on independentlypublished data.6,7,8 Shear, tensile, and bending stresses arebelieved to be the most common sources of cement failure.9,10Important termsPorosity: The presence of air pockets in the mixed cements; lower porosityresults in higher fatigue strength.5Shear strength: Strength of a material against sliding forces parallel to thedirection of forceTensile strength: Strength of a material against stretching or pulling forcesBending strength: Strength of a material against deforming or breakingunder a force, also known as flexural strengthConfidential – For internal use only by Smith & Nephew employees and sales force. Do not publicly distribute.

Cement accessoriesSmith & Nephew is a total cement company. Everything your surgeons need for cementedknees, hips and shoulder cases, is included in the following accessories.VORTEX Vacuum Mixer and Vacuum BowlThe VORTEX Vacuum Mixer has many unique features. It has agear driven mechanism, which provides three mixing revolutionswith each handle turn. The VORTEX mixer is ergonomically angledto provide a consistent homogeneous mix. The VORTEX cansuccessfully mix several types of cement and can handle from halfunits to three units at one time (1 unit 40g). The VORTEX innercylinder adapts to Smith & Nephew and Stryker cement guns. PREP-IM Enhance Total Hip KitThe PREP-IM Enhance Total Hip Kit sets the standard in total hip prepkits. It is a pre-cementing bone preparation kit for total joint surgerywith tools and implants to clean the cut bone and intramedullarycanal, plug the intramedullary canal prior to cementing and cleanthe cemented areas. The kit contains instruments designed to clearbone and tissue debris, and to remove excess blood, fluid andcement in order to improve interdigitation of the bone cement. The kitcontains the following:2 BUCK Cement Restrictors, 18.5mm and 25mm1 BUCK Disposable Inserter1 Femoral Canal Brush, 19mm1 Femoral Canal Suction Absorber1 Medium Femoral Pressurizer2 CONCISE Cement SculpsBUCK Cement RestrictorsThe BUCK Cement Restrictor provides cement support of the femoralor tibial prosthesis stem by plugging the intramedullary canal. TheBUCK restrictor can be inserted quickly and accurately. The distal ringcenters the restrictor and the proximal ring conforms to the inside ofthe medullary canal to address a wide range of canal variations. ThePREP-IM Enhance Total Hip Kit includes both the 18.5mm and 25mmsizes, but the BUCK Restrictor is also available in 13, 30 and 35mmsizes. The BUCK Restrictor can also be purchased in a combinationof 18.5, 25 and 30mm sizes with disposable inserters.POWERPULSE LavageThe POWERPULSE Lavage System is a metal, precision-engineeredsurgical instrument which provides excellent bone and tissuecleansing in the O.R. Competitive systems are fully disposableresulting in extra weight in medical waste leading to an increasedexpense for hospitals. With POWERPULSE, only the nozzles aredisposed of, significantly reducing the medical waste. POWERPULSEis powered by existing O.R. sources so there are no battery packsor special pumps to purchase. POWERPULSE also features a nonclogging suction design and a variable speed trigger for improvedcontrol of pulse strength and frequency.Confidential – For internal use only by Smith & Nephew employees and sales force. Do not publicly distribute.

Cement mixing techniquesThe following technique is for informational and educational purposes only. It is not intended to serve as medical advice. It is the responsibility of thetreating physician to determine and utilize the appropriate products and techniques according to their own clinical judgment for each of their patients.For detailed product information, including indications for use, contraindications, effects, precautions and warnings, please consult the product'sInstructions for Use (IFU) prior to useHand mixing technique – Bowl and spatulaThe RALLY HV bone cement is recommended to be mixed by bowl and spatula as it is a high viscosity cementand more easily and uniformly mixed by hand. The RALLY MV cement can also be mixed by hand if desired.Break the ampoule of monomer at the neck and pour into the sterile mixing bowl.Note: Take care to gently break away from the body as to prevent injury and small glass particles in the mixture.2. Add all of the powder from the packet carefully into the bowl.3. Stir with the spatula slowly and carefully for one minute taking care to avoid spilling contents.4. Allow to stand for 30 seconds* for the escape of air and for cement to reach the dough phase.1.Vacuum mixing technique – RALLY All-in-One SystemThe RALLY All-in-One System is a premier, unique product composedof 70g of antibiotic cement completely contained inside the mixingand dispensing system. The cement components are isolatedfrom outside contamination or influences and has a filter screen toprevent glass from entering the final cement mixture. This systemcomes in both RALLY HVAB and RALLY MVAB formulations.The RALLY All-in-One system can be connected to a vacuum sourcesuch as a wall suction or dedicated vacuum pump, or it can beused without vacuum.2. With the system standing upright on the base, pop the monomervial with a sharp hit to the button on the top of the system. Whenyou see monomer flowing, pump the release button several timesto transfer all of the monomer into the powder chamber.1.Tip: Before releasing the monomer, invert the system and lightlytap the powder chamber to loosen the powder.3. Grab the base mixing handle and pull the mixing handle in andout for one minute.Tip: After a few seconds of mixing upright, turn the device upsidedown and tap the mixing chamber several times to loosen anypowder not yet mixed in.4. Disconnect the vacuum source.5. Fully extend the mixing handle until it is engaged and turn thehandle counter clockwise to disengage it from the system.6. Attach the breakaway nozzle by screwing onto the end of systemwhere the mixing handle was disconnected.7. Push the monomer end of the system into the powder chamberand load the whole system into the RALLY All-in-One CementGun for dispensing.Tip: Pushing the monomer chamber into the powder chamberto the point where cement reaches the dispensing point beforeloading into the gun, removes more air from the cement chamber.*Adjust according the temperature/time data for RALLY HV and RALLY MV cements.Confidential – For internal use only by Smith & Nephew employees and sales force. Do not publicly distribute.

Vacuum mixing technique – VORTEX Mixing SystemToday, most operating rooms mix cement under a partial vacuum, which helps to decreaseporosity and fumes created during mixing. The following is a brief description of the mixingtechnique using RALLY MV (40g 1 dose) and the VORTEX Vacuum Mixer.The VORTEX should be connected to a vacuum source such as a wall suction or dedicatedvacuum pump.2. Pour powder and monomer into the bowl as follows: 1 Dose – Pour all powder into the bowl, then all the liquid monomer down the side chute. 2 Doses – Pour 1 packet of powder into the bowl, followed by 1 ampoule of monomerdown the side chute. Repeat with second packet of powder and ampoule of monomer. 3 Doses* – Follow the procedure for 2 doses, repeating with the third dose of the cement.3. Affix the VORTEX lid with the stirring element firmly attached.4. Activate the vacuum source to 25mmHg.5. Turn the VORTEX handle at 2 cycles per second for 1 minute.1.Tip: Tap sharply on the side of the mixer occasionally during mixing to dislodge anyunwetted powder in the bowl.6. Shut off the vacuum and remove the vacuum from the mixer. Remove the lid.To apply cement via syringe application:Extract the funnel and cartridge (inner components) from the mixer and unscrewthe funnel.8. Connect the desired nozzle.9. Place the assembly in the VORTEX gun for dispensing.7.To apply cement via bowl and spatula:7. Extract the funnel and cartridge and insert the push up rod into the base of the cartridge.8. Push the rod upwards until all of the cement is inside the funnel.9. Use as a bowl.Note: The VORTEX mixer can be reused if another batch of cement is needed, unlikeother mixing systems. Simply remove the stirring element, funnel, and cartridge fromthe VORTEX mixer and install the new components from the VORTEX Re-Use Kit.*Not recommended for RALLY HV.Confidential – For internal use only by Smith & Nephew employees and sales force. Do not publicly distribute.

Total Hip Arthroplasty cementing procedureThe following cemented hip stem technique is a portion from the Smith & Nephew cemented hip stem surgicaltechniques for CPCS, Spectron, and Synergy stems. Please reference the Surgical Techniques for CPCS, Spectron,and Synergy stems as well as the Indications for Use for all products listed.11,12,13Step 1The proximal flange of the BUCK cement restrictorshould always be larger than the distal canaldiameter to ensure a good canal fit. Accuratecement restrictor depth placement is thendetermined by placing the prosthesis selectedfor implantation next to the inserter (Figure 1)and adding 2cm to the length.Figure 1Step 2 (Optional)Remove the vent-occluding membrane byinserting the vent-opening tool into the threadedend of the restrictor and pushing the pin throughthe venthole (Figure 2). Remove and discard theplastic membrane.Figure 2Step 3Screw the cement restrictor onto the inserter witha clockwise motion. Insert the device to the level ofthe medullary canal you have already determined(Figure 3). Once this level has been reached,disengage the restrictor from the inserter witha counterclockwise twisting maneuver. Removethe inserter from the medullary canal. Should itbe necessary to remove the restrictor prior tocement insertion, it can be re-attached to theinserter rod and pulled out of the canal. In thisway, the surgeon may adjust the restrictor asmany times as required. After placing the BUCKcement restrictor, prepare the femoral canal bypulse lavaging, clearing debris with the femoralcanal brush, and repeat lavaging if necessary toremove remaining debris.Figure 3Confidential – For internal use only by Smith & Nephew employees and sales force. Do not publicly distribute.

Step 4After insertion of the BUCK restrictor, the femoralcanal should be cleaned and dried. First usethe POWERPULSE lavage system to clean thecanal. Next, hook the femoral suction absorberto suction and place back inside the canal whilemixing the cement (Figure 4).Step 5Fill the canal with bone cement in a retrogrademanner (Figure 5). It is important that the proximalfemur be filled with cement that is placed underpressure to assure adequate packing of theproximal femur.Step 6After the cement is injected into the canal,break off the long nozzle and place the femoralpressurizer over the short nozzle. Apply thedisposable femoral pressurizer into the mouth ofthe canal (Figure 6). This will occlude the canaland compress the cement. Maintain firm pressureuntil the cement is in the doughy state and canwithstand displacement and will allow for propercement interdigitation into the trabecular bone.Withdraw the femoral pressurizer and removeany extruded cement around the periphery ofthe canal.Step 7Once the cement is securely packed in theconfines of the medullary canal, insert the femoralcomponent (Figure 7). Note that the restrictor levelmaintains a 2cm cement mantle at the distal endof the prosthesis.Figure 4Figure 5Figure 6Step 8After the stem has been inserted into the canal,remove any excess cement around the prosthesiswith the Concise Cement Sculps (Figure 8).Figure 7Figure 8Confidential – For internal use only by Smith & Nephew employees and sales force. Do not publicly distribute.

The sticking points RALLY Bone CementHigh and medium viscosity cementsLong-lasting spearmint green color for easy visualization of thecement now or down the road for implant revisionsLow porosity for increased fatigue lifeUnique 70g All-in-One system for completely isolated mixingand dispensing of the cementVORTEX Gear driven stirring mechanism provides consistent mix No cement transfer results in less cement waste Intuitive design minimizes learning curve PREP-IM EnhanceContains everything needed for femoral or tibial preparationPOWERPULSE Pulse Lavage System Less biohazard / medical waste Uses existing OR power sources Has a non-clogging suction design BUCK Cement RestrictorCan be inserted quickly and accuratelyThe absolute bottom line of cement & accessories –Smith & Nephew is a total cement company offeringa comprehensive range of products to meet allcementing needs.Confidential – For internal use only by Smith & Nephew employees and sales force. Do not publicly distribute.

Catalog informationBone CementCat. ItemDescription7127-1560 RALLY HV Bone Cement, 40 grams7127-1570 RALLY HV AB Bone Cement, 40 grams7127-1580 RALLY MV Bone Cement, 40 grams7127-1590 RALLY MV AB Bone Cement, 40 grams7127-1340 VERSABOND Bone Cement, 40 grams7127-1440 VERSABOND AB Bone Cement, 40 gramsMixer and Dispensing ComponentsMixing SystemsCat. ItemDescription7127-1600 RALLY HV AB All-in-One System, 70 grams7127-1680 RALLY MV AB All-in-One System, 70 grams7127-0070 VORTEX Vacuum Mixing System7127-0071 VORTEX Re-use Kit7127-0068 VORTEX Vacuum Mixing Bowl210098Mixing Bowl with Spatula7127-0020 MIXOR Vacuum Mixing System w/Syringe7127-0069 VORTEX Vacuum Mixing Sample7127-0090 MIXOR System w/ Syringe SampleNozzlesCat. ItemDescription7127-0080 VORTEX Standard Breakaway Nozzle7127-0081 VORTEX Long Tapered Nozzle7127-0082 VORTEX Angled Nozzle7127-0084 VORTEX Revision Nozzle7127-0085 VORTEX Umbrella Nozzle7127-0072 VORTEX Nozzle AdaptorMixing and Dispensing AccessoriesCat. ItemDescription7127-1610 RALLY All-in-One Cement Gun7127-2001 VORTEX Cement Gun7127-0042 MIXOR Foot Pump Only7127-0041 MIXOR Vacuum Hose Only7127-0050 MIXOR Foot Pump Connector, Schraeder7127-0051 MIXOR Foot Pump Connector, Drager7127-0052 MIXOR Foot Pump Connector, D.I.S.S7127-0060 MIXOR Stryker Foot Pump AdapterPulse LavagePOWERPULSE Lavage SystemCat. ItemDescription7127-7000 Handpiece w/ Zimmer Coupling7127-7001 Powerhose w/Zimmer Coupling7127-7004 Hip/Knee Disposable Unit w/ Suction7127-7005 Hip/Knee Disposable Unit w/o SuctionConfidential – For internal use only by Smith & Nephew employees and sales force. Do not publicly distribute.

Cement AccessoriesBUCK Cement RestrictorsCat. ItemDescription91-4535BUCK Cement Restrictor 13mm12-9418BUCK Cement Restrictor, 18.5mm12-9419BUCK Cement Restrictor, 25mm7127-9420 BUCK Cement Restrictor, 30mm7127-9421 BUCK Cement Restrictor, 35mm7127-9422BUCK Cement Restrictor w/DisposableInserter, 18.5mm7127-9423BUCK Cement Restrictor w/DisposableInserter, 25mm7127-9424BUCK Cement Restrictor w/DisposableInserter, 30mm11-2428BUCK Cement Restrictor Inserter11-0028Vent Opening ToolPREP-IM Enhance Total Hip KitCat. ItemDescription12-1010PREP-IM Enhance Total Hip KitIncludes:12-9418BUCK Cement Restrictor, 18.5mm12-9419BUCK Cement Restrictor, 25mm11-2428BUCK Disposable Inserter11-0003Femoral Canal Brush, 19mm11-0037Femoral Canal Suction Absorber, Std7127-0027 Medium Femoral Pressurizer11-1000CONCISE Cement SculpsReferences:Ref. RALLY Bone Cement IFUs.Biomet Cobalt IFU.3. KD Kuehn, W Ege, U Gopp. Acrylic bone cements: composition and properties. Orthop Clin N Am. 2007. 36:17-28.4. Data provided by the manufacturer.5. M Jasty, et al. Porosity of Various preparations of acrylic bone cements. Clin Ortho and Rel Res. 1990. 299:122-9.6. Ref. Smith & Nephew OR 15-135.7. Data provided by the manufacturer.8. G Lewis. Properties of Acrylic Bone Cement: State of the Art Review. J Biomed Mater Res. 1997. 38:155-82.9. D Waanders. et al,. The mechanical effects of different levels of cement penetration at the cement-bone interface. J Biomechanics; 43, pp. 1167-75 2010.10. Perez, et al, A comparative FEA of the debonding process in different concepts of cemented hip implants. Med Eng & Phys; 28(6), pp. 525-33 200611. Ref. Smith & Nephew. CPCS Surgical Technique. 7138-0787. 05/07.12. Ref. Smith & Nephew. Spectron Revision Surgical Technique. 7138-0631. 09/03.13. Ref. Smith & Nephew. Cemented Synergy Surgical Technique. 7138-0351. 11/04.1.2.Please see the Instructions for Use for each product for a complete list of indications, warnings, precautions and other important medical information.Confidential – For internal use only by Smith & Nephew employees and sales force. Do not publicly distribute.Supporting healthcare professionals for over 150 yearsSmith & Nephew, Inc., 1450 Brooks Road, Memphis, TN 38116, USAPhone: 1-901-396-2121, Information: 1-800-821-5700, Orders/inquiries: Trademark of Smith & Nephew. All trademarks acknowledged. 2016 Smith & Nephew.03799 V1 02/16

The PREP-IM Enhance Total Hip Kit sets the standard in total hip prep kits. It is a pre-cementing bone preparation kit for total joint surgery with tools and implants to clean the cut bone and intramedullary canal, plug the intramedullary canal prior to cementing and clean the cemented areas. The