SHOULDER MODULARITY REMEDY SHOULDER SYSTEM MODULAR STEMS HEADS. REMEDY Shoulder Spacers:

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2 HOUDER YTE HOUDER ODUARITY The houlder pacer is part of the treatment foreseen in a two-stage procedure performed in the event of permanent prosthesis infection. The houlder pacer implant is intended for temporary use only (180 days or less). It allows basic joint mobility and releases antibiotics into the joint area to protect the implant from bacterial colonization. A second surgery will be required at a later date to remove the houlder pacer and replace it with a permanent shoulder joint implant. houlder pacers: ingle-use medical devices/ethylene oxide sterile Formed with bone cement (PA) and gentamicin 50mm ODUAR TE arge tem tainless steel rod reinforces the humeral stem 45mm ODUAR HEAD Head sizes interchangeable with stems for surgical flexibility edium tem 40mm mall tem u u u Variable head and neck design allows desired placement and positioning up to 9mm tainless steel rods within stems provide added mechanical strength 2

3 HIP YTE HIP ODUARITY ODUAR TE The Hip pacer is part of the treatment foreseen in a two-stage procedure performed in the event of permanent prosthesis infection. The Hip pacer implant is intended for temporary use only (180 days or less). It allows basic joint mobility and releases antibiotics into the joint area to protect the implant from bacterial colonization. ong tem arge A second surgery will be required at a later date to remove the Hip pacer and replace it with a permanent hip joint implant. ong tem edium Hip pacers: ingle-use medical devices/ethylene oxide sterile ong tem mall Formed with bone cement (PA) and gentamicin hort tem arge tainless steel rod reinforces the femoral stem hort tem edium hort tem mall u u u tainless steel rods within stems provide added mechanical strength Variable head and neck design allows desired placement and positioning up to 1mm 60mm ODUAR HEAD Head sizes interchangeable with stems for surgical flexibility 54mm 46mm 3

4 KNEE YTE KNEE INTERCHANGEABIITY ARGE ODUAR KNEE The Knee pacer is part of the treatment foreseen in a two-stage procedure performed in the event of permanent prosthesis infection. The Knee pacer implant is intended for temporary use only (180 days or less). It allows basic joint mobility and releases antibiotics into the joint area to protect the implant from bacterial colonization. A second surgery will be Femoral Component 4mm (arge) required at a later date to remove the Knee pacer and replace it with a permanent knee joint implant. Tibial Component 80mm (arge) Tibial Wedge 80mm - Width 10mm - Height (arge) Knee pacers: ingle-use medical devices/ethylene oxide sterile Formed with bone cement (PA) and gentamicin TOTA YTE INTERCHANGEABIITY 65% of cases result in different size femur and tibia* 35% of cases use a tibial wedge* EDIU ODUAR KNEE A ODUAR KNEE Femoral Component 64mm (edium) Femoral Component 54mm (mall) Tibial Component 0mm (edium) Tibial Component 60mm (mall) Tibial Wedge 0mm - Width 10mm - Height (edium) Tibial Wedge 60mm - Width 10mm - Height (mall) ize X Femoral Component also available upon request 4 * Internal OsteoRemedies data

5 EUTION PROFIE OF ANTIBIOTIC ANTIBIOTIC TREATENT PAN Antibiotics In pacers: pacers 4.8% Gentamicin In ulfate olds Various/Inconsistent Antibiotics In Cement For Fixation ame With olds Or pacer ystem ystemic Antibiotic Treatment Plan ame With olds Or pacer ystem EUTION OVERVIEW data supported by third-party analysis and referenced in available testing report mg/.2% AB Release 150 mg/8.5% AB Release Data of Palacos R+G and implex P T Tobramycin are taken from: oojen et al., J. Arthroplasty Palacos is a registered trademark of Heraeus edical GmbH implex P Tobramycin is a trademark of tryker Intra-Op olds 2 mg/2.1% AB Release 24 mg/0.9% AB Release Weeks 6 onths REEDY Hip w/ ong tem (54mm Head) REEDY Knee w/ edium Femur, Tibia, Insert Palacos R+G (51mm Head) REEDY Hip With hort tem (54mm Head) implex P Tobramycin (51mm Head) 5

6 OsteoRemedies and corporate mark are registered trademarks of OsteoRemedies, C 2015 RG 11/15 HOUDER PACER TECHNIQUE TEP 1 In accordance with the existing shoulder manufacturer s technique, prepare the infected joint space by first removing the shoulder prosthesis and any PA cement, if present, and any hardware that may be a reservoir of infection. TEP 2 Using the houlder pacer Trials and templates, select the appropriate size humeral stem and humeral head components. TRIA TEP 3 HOUDER PACER RG Once the appropriate humeral head size is selected, open the package and remove the monomer vial. Carefully, break the vial open and pour all the monomer into the screw opening of the humeral head. Continue to prepare the joint space with aggressive debridement, pulse lavage and other standard practices for preparing the infected joint space Poplar Avenue uite 120 emphis, TN info@osteoremedies.com OsteoRemedies.com TEPATE Insert and seal the hole with the plastic cover cap supplied with the humeral head. hake the head for 60 seconds to ensure all of the threads within the head are wet with monomer. COVER CAP TEP 4 Remove the plastic cap, pour the remaining monomer out and place the head on the humeral stem. Begin turning the head until the desired offset and length are achieved. Approximate working time for the head is 10 to 15 minutes. Important Note: Once the head location is selected, be sure not to continue to adjust the head location as this could affect the fixation between the head and the stem. WARNING: The humeral head must be seated past the afety ine marked in purple on the stem thread. TEP 5 Using UNITE AB Bone Cement, or other FDAcleared PA, apply cement to the proximal aspect of the stem. The use of bone cement is compulsory to avoid rotation and to limit the risk of dislocation or spacer loosening. TEP 6 Insert the humeral stem (with head properly affixed) into the canal to the desired position. On the stem trials, the purple line is designated with a missing thread on the stem trunnion. Note: Bone cement may also be applied once the stem is seated within the humeral canal. 6

7 HOUDER PECIFICATION ODUAR HUERA TE 3 ODUAR HUERA HEAD 4 HOUDER PACER () Description Catalog # Gentamicin Base (g) odular Humeral Head 40mm RHH odular Humeral Head 45mm RHHD odular Humeral Head 50mm RHHG odular Humeral tem - mall RH odular Humeral tem - edium RHD odular Humeral tem - arge RHG

8 HIP PACER TECHNIQUE TEP 1 TEP 2 TEP 3 In accordance with the existing total joint manufacturer s technique, prepare the infected joint space by first removing the prosthesis and any PA cement, if present, and any hardware (which may be a reservoir of infection). Using the pacer Trials and templates, select the appropriate size femoral stem and femoral head components. TEPATE TRIA Once the appropriate head size is selected, open the package and remove the monomer vial. Break the vial open and pour all the monomer into the screw opening of the head. Continue to prepare the joint space with aggressive debridement and pulse lavage. TEP 4 Insert and seal the hole with the plastic cover cap supplied. hake the head for 60 seconds to ensure all of the threads within the head are wet with monomer. COVER CAP (Approximate working time for head position is 10 to 15 minutes.) TEP 5 Remove the cover cap, pour the remaining monomer out and place head onto the femoral stem. Begin to turn the femoral head until the appropriate off-set is achieved. Important Note: Once the head location is selected, be sure not to continue to adjust the head location as this could affect the fixation between the head and the stem. WARNING: The head must be seated past the afety ine marked in blue or purple on the stem thread. On the Trials, the blue or purple line is designated with a missing thread on the trunnion. TEP 6 Using UNITE AB Bone Cement, or any FDAcleared AB PA, apply cement to the proximal aspect of the stem. The use of the cement is compulsory to avoid rotation and to limit the risk of dislocation. Note: Cement may also be applied once seated within the femoral canal. TEP Insert the stem (with head properly affixed) into the canal. 8

9 HIP PECIFICATION 2 1 ODUAR HEAD ODUAR TE ODUAR ONG TE HIP PACER () Description Catalog # Gentamicin Base (g) odular Head 46mm RHHD odular Head 54mm RHHDD odular Head 60mm RHHDG odular tem - mall RHT odular tem - edium RHTD odular tem - arge RHTG odular ong tem - mall RH odular ong tem - edium RHD odular ong tem - arge RHG

10 KNEE PACER TECHNIQUE TEPATE TRIA TEP 1 In accordance with the existing total joint manufacturer s technique, prepare the infected joint space by first removing the prosthesis and any PA cement, if present, and any hardware (which may be a reservoir of infection). Continue to prepare the joint space with aggressive debridement and pulse lavage. TEP 2 Using the pacer Trials and templates, select the appropriate size femoral and tibial components. It is important that the joint is neither loose nor tight, therefore the surgeon will have to consider the additional room occupied by the cement needed for the fixation. TEP 3 Using UNITE AB Bone Cement, or any FDA-cleared AB PA, apply cement over the entire surface of the component and tibial plateau and insert into the tibia. TEP 4 Apply PA bone cement (see tep 3) to the femoral component and femoral surface. 10 OPTIONA If the tibial bone defect is excessive and additional height is required, apply PA to the tibial wedge/ insert and cement this to the inferior aspect of the tibial component. TEP 5 Reduce the joint, removing all the excess cement, avoiding the cement that may go on the articular surface. To assure correct alignment of the components, make flex/extension movements before the cement curing occurs. Then close and check flex/extension movements and lateral stability. Depending on the stability of the knee, it may be necessary to apply a brace to avoid the risk of dislocation. Note: When placing the components with cement, DO NOT impact the device with a mallet. It is recommended to use hand pressure only while placing the components.

11 KNEE PECIFICATION FEORA COPONENT TIBIA COPONENT TIBIA WEDGE/INERT KNEE PACER () Description Catalog # Gentamicin Base (g) Tibial Component 60mm RKTB Tibial Component 0mm RKTBD Tibial Component 80mm RKTBG Femoral Component 54mm RKF Femoral Component 64mm RKFD Femoral Component 4mm RKFG Femoral Component 84mm RKFX Tibial Wedge/Insert 60mm RKIN Tibial Wedge/Insert 0mm RKIND Tibial Wedge/Insert 80mm RKING

12 UNITE AB BONE CEENT UNITE AB Bone Cement is a high-viscosity, radiopaque bone cement containing and releasing gentamicin sulphate for manual application. UNITE AB Bone Cement is a single-use, sterile medical device provided in doses of 40g. UNITE AB Bone Cement contains 1 gram of gentamicin per 40 gram dose versus 0.5 grams in Palacos R+G. With a lower ratio of monomer to powder as compared to market leading bone cement mixtures, UNITE provides benefits such as: ower maximum temperature from the chemical reaction may reduce the risk to surrounding tissues. Reduced toxicity for those handling the cement. Reduced cement shrinkage may improve implant fixation. pecifically designed formulation to work effectively with pacers Description Catalog # (G) UNITE AB Bone Cement UNITE40 40 UNITE Palacos R Cement Gentamicin Product ixing Waiting Working etting Total 1g Gentamicin 0.5g Gentamicin UNITE Cement Gentamicin in Powder 2.5% 1.25% Palacos R+G Gentamicin in Resin 1.8% 0.84% Approximate set time as tested at 4 F. OsteoRemedies, C 6800 Poplar Avenue uite 120 emphis, TN OTEO-X info@osteoremedies.com OsteoRemedies.com OsteoRemedies, REEDY, UNITE and the corporate mark are registered trademarks of OsteoRemedies, C REEDY and UNITE are manufactured for OsteoRemedies, C V9 Palacos is a registered trademark of Heraeus edical GmbH