lution · femoral component 54mm (small) tibial component 60mm (small) tibial wedge 60mm - width...

2

ELUTION OVERVIEW

ANTIBIOTIC TREATMENT PLAN Antibiotics In Spacers: REMEDY® Spacers – 4.8% Gentamicin Sulfate

Molds – Various/Inconsistent

Antibiotics In Cement For Fixation Same With Molds Or REMEDY® Spacer System

Systemic Antibiotic Treatment Plan Same With Molds Or REMEDY® Spacer System

1

2

3

REMEDY® data supported by third-party analysis and referenced in available testing report

Data of Palacos® R+G and Simplex PTM Tobramycin are taken from: Moojen et al., 2008 - J. Arthroplasty

Palacos is a registered trademark of Heraeus Medical GmbH

Simplex P Tobramycin is a trademark of Stryker®

REMEDY®

ELUTION PROFILE OF ANTIBIOTICS

Weeks

20

40

60

80

100

120

140

160

180

0 1 2 3 4 5 6 7 8 9

REMEDY®

Intraoperative Molds

205 mg/7.2% AB Release



6 Months

200


Intraoperative Hip Spacer Mold w/ Simplex P™ Tobramycin (51mm Head)

REMEDY Hip w/ Medium Short Stem (54mm Head)®

REMEDY Hip w/ Medium Long Stem (54mm Head)®

REMEDY Knee w/ Medium Femur, Tibia, Insert ®

REMEDY Shoulder w/ Medium Humeral Stem (45mm Humeral Head)

®

Intraoperative Hip Spacer Mold w/ Palacos R+G (51mm Head)®

87 mg/10.9%AB Release

Cu

mu

lati

ve

Re

lease

(m

g)

3

Stainless steel rod reinforces the

stem extension

TOTAL SYSTEM INTERCHANGEABILITY

100mm 175mm

S LM

S LM

L XL

S MStainless steel

rod reinforces the stem extension

REMEDY®

ELUTION PROFILE OF ANTIBIOTICS REMEDY® STEMMED KNEE SPACER

4

STEP 1In accordance with the existing total joint manufacturer’s technique, prepare the infected joint space by first removing the prosthesis and any PMMA 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.

STEP 2Using the REMEDY® Stemmed Knee Spacer Trials, select the appropriate size femoral and tibial components. If a stem extension is necessary, select between the two available lengths and place through the opening of the femoral and/or tibial stemmed trial to ensure the stem is able to be fully seated. 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.

STEP 3Apply UNITE® AB Bone Cement (or any FDA cleared AB Cement) over the tibial component surface in contact with the bone and tibial plateau.

If the tibial bone defect is excessive and additional height is required, apply cement to the tibial wedge insert and cement it to the inferior aspect of the tibial component.

STEP 4With additional cement fill the housing of the tibial component, insert the conical tip of the selected stem extension and complete the stem fixation by using cement around stem and housing connection. If additional fixation is necessary, cement may be applied to the nearest pocket of the stem extension component.

Give the stem the necessary angulation, up to 8° in all the directions, to match the patient’s tibial canal anatomy. Then insert the construct into the tibia while cement is still in a moldable phase avoiding excess cement to adhere to the joint surfaces.

Remove the cement from the posterior tibial intercondylar notch.

Note: If stem extensions are not used, cement will be used only for the fixation of the tibial and/or femoral components.

STEP 6Apply cement into the housing of the femoral component, and repeat Step 4 as applicable to the femoral component.

STEP 7Reduce the joint ensuring all cement is removed from the articular surface. To assure correct alignment of the components, make flex/extension movements before the cement curing occurs. DO NOT forcefully bring the knee into full extension as too much force could lead to fracture of the femoral or tibial components. Then, close and check flexion/extension movements and medial/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.

STEP 5Apply UNITE® AB Bone Cement (or any FDA cleared AB Cement) over the femoral component in contact with the bone and femoral surface.

STEP 3OP

TIO

NA

L

REMEDY® STEMMED KNEE SPACER TECHNIQUE

Description

REMEDY Stemmed Femoral Component SM

REMEDY Stemmed Femoral Component MD

REMEDY Stemmed Femoral Component LG

REMEDY Stemmed Femoral Component XL

REMEDY Stemmed Tibial Component SM

REMEDY Stemmed Tibial Component MD

REMEDY Stemmed Tibial Component LG

REMEDY Stem Extension Component 100

REMEDY Stem Extension Component 175

REMEDY Tibial Wedge/Insert Small

REMEDY Tibial Wedge/Insert Medium

REMEDY Tibial Wedge/Insert Large

54

64

74

78

0.6

0.9

1.2

1.6

0.4

0.6

0.8

0.1

0.1

0.3

0.5

0.7

(MM)

1 2 3 4 5 6 7 8 9 10 11 Catalog #

RSKFSM

RSKFMD

RSKFLG

RSKFXL

RSKTSM

RSKTMD

RSKTLG

RSK100

RSK175

RKINSM

RKINMD

RKINLG

Gentamicin Base (g)

®

®

®

®

®

®

®

®

®

41.6

49.3

56.3

63.4

9.5

10.5

11.5

12.5

14

14

14

14

14

14

14

14.5

14.5

14.5

60

70

80

60

70

80

36

42

48

36

42

48

11

11

11

7.8

8.2

8.8

100

175

12

12

8

8

10

10

10

®

®

®

STEMMED KNEE SPECIFICATIONS

1

2

3

4

4

5

6

78 4

6

5

8

9

1011

1

2

3

4

4

5

6

78 4

6

5

8

9

10111

2

3

4

4

5

6

78 4

6

5

8

9

1011

1

2

3

4

4

5

6

78 4

6

5

8

9

1011

1

2

3

4

4

5

6

78 4

6

5

8

9

1011

REMEDY® STEMMED FEMORAL COMPONENT

REMEDY® STEM EXTENSION COMPONENT

REMEDY® STEMMED TIBIAL

COMPONENT

REMEDY® TIBIAL WEDGE/

INSERT

5

Femoral Component

54mm(Small)

TibialComponent

60mm(Small)

Tibial Wedge60mm - Width10mm - Height

(Small)

KNEE INTERCHANGEABILITYThe REMEDY® Knee Spacer is part of the treatment foreseen in a two-stage

procedure performed in the event of permanent prosthesis infection. The

REMEDY® Knee Spacer 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 REMEDY® Knee Spacer and replace it

with a permanent knee joint implant.

REMEDY® Knee Spacers:• Single-use medical

devices/ethylene oxide sterile

• Formed with bone cement

(PMMA) and gentamicin

REMEDY® LARGE MODULAR KNEE

L

REMEDY® SMALL MODULAR KNEE

S

Femoral Component

74mm(Large)

TibialComponent

80mm(Large)


(Large)

Femoral Component

64mm(Medium)

TibialComponent

70mm(Medium)


(Medium)

REMEDY® MEDIUM MODULAR KNEE

M


M

L

M

L

S

M

S

S

L

L

M

S

S

L

L

S

M

M

• 65% of cases result in different

size femur and tibia*

• 35% of cases use a tibial wedge*

* Internal OsteoRemedies data

REMEDY® KNEE SYSTEM

Size XL Femoral Component also available upon request

6


REMEDY® KNEE SPACER TECHNIQUE

STEP 1In accordance with the existing total joint manufacturer’s technique, prepare the infected joint space by first removing the prosthesis and any PMMA 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.

STEP 2Using the REMEDY® Spacer Trials, 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.

Apply PMMA bone cement (see Step 3) to the femoral component and femoral surface.

STEP 4STEP 3Using UNITE®AB Bone Cement, or FDA cleared gentamicin-based PMMA, apply cement over the entire surface of the component and tibial plateau and insert into the tibia.

OPTIONAL

STEP 5Reduce 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.

If the tibial bone defect is excessive and additional height is required, apply PMMA to the tibial insert wedge and cement this to the inferior aspect of the tibial component.

TRIALS

7

KNEE SPECIFICATIONS

9

5

4

7

REMEDY® TIBIAL INSERT

WEDGE

3

REMEDY® FEMORAL COMPONENT

1

2

4

7

8

REMEDY® TIBIAL

COMPONENT

6

5

REMEDY® KNEE SPACER

Description

REMEDY Tibial Component 60mm



REMEDY Femoral Component 54mm



REMEDY Tibial Insert Wedge 60mm



54

64

74

41.6

49.3

56.3

9.5

10.5

11.5

60

70

80

60

7

80

36

42

48

36

42

48

25

25

25

7.8

8.2

8.8

0.4

0.6

0.9

0.5

0.8

1.2

0.3

0.5

0.7

14.5

14.5

14.5

14

14

14

10

10

10

(MM)

1 2 3 4 5 6 7 8 9 Catalog #

RKTBSM

RKTBMD

RKTBLG

RKFMSM

RKFMMD

RKFMLG

RKINSM

RKINMD

RKINLG

Gentamicin Base (g)

®

®

®

®

®

®

®

®

®

8

REMEDY SPECTRUM® GV HIP SPACER

REMEDY SPECTRUM® GV Hip elution extends beyond 28 days5 while intra-operative mold elution was undetectable after 14 hours6

Days

0 2 4 6 8

Cummulative Antibiotic Release - Comparison

10 12 14 16 18 20 22 24 26 28

250

200

150

100

50

0

Elu

tio

n A

mo

un

t (m

g)

225.4

161.4

29.523.013.1

Intraoperative Molds(3.6g Tobramycin & 1g Vancomycin Per Construct)

6

Prostalac: Large Stem

Prostalac: Medium Stem

Prostalac: Small Stem

Source: Prostalac HDE H000004

REMEDY SPECTRUM GV Hip Short(2.2g Vancomycin & 2.2g Gentamicin Per Construct)

®

REMEDY SPECTRUM GV Hip Long(2.4g Vancomycin & 2.4g Gentamicin Per Construct)

®

REMEDY SPECTRUM GV Hip w/Medium Long Stem (54mm Head)

REMEDY SPECTRUM GV Hip w/Medium Short Stem (54mm Head)

®

®

REMEDY SPECTRUM GV Hip Spacers tested in Lab A while Prostalac Spacers were tested in Lab B

®

THE FIRST GENTAMICIN +VANCOMYCIN HIP SPACER*

Improved OR efficiency

Long term elution compared to intra-operative molds

9

Averages 4.5 grams Gent + Vanc per construct

Gentamicin + Vancomycin Released

10

POWERFUL COMBINATION, RELIABLE PERFORMANCE

Powerful:• 4X the antibiotic content compared to Palacos® R+G

• Dual Antibiotic Spectrum includes Gram (+) and Gram (-) Pathogens

Reliable:• Mechanical Performance comparable to Palacos® R+G

• Exceeded Required ISO Bone Cement Standards

0 1 2 3 4 5 6 7 9 10 11 12 13

Tem

pe

ratu

re (

°C)

Tem

pe

ratu

re (

°F)

Setting Time (Min)

30

29

28

27

26

25

24

23

22

21

20

19

18

17

16

15

86.0

84.2

82.4

80.6

78.8

77.0

75.2

73.4

71.6

69.8

68.0

66.2

64.4

62.6

60.8

59.0

14 15 16 17 18 19 20

TOLERANCE -

TOLERANCE +

NORMAL RELATIONSHIP

SPECTRUM® GV Bone Cement is indicated for use only with REMEDY SPECTRUM® GV Hip Spacer

40g Bag 1g 1g 2g

2.5% 2.5% 5%

Gentamicin BaseCatalog #

SPECTRUM40Spectrum GVBone Cement

Vancomycin Base Total

®

SPECTRUM® GV BONE CEMENT

3500

3000

2500

2000

1500

1000

500

0

Be

nd

ing

Mo

du

lus

(MP

a)

SPECTRUM® GV 2g

Palacos®R+G 0.5g

Palacos® 1g Vanc

Palacos® 2g Vanc

70

60

50

40

30

20

10

0

Be

nd

ing

Str

en

gth

(M

Pa)

SPECTRUM® GV 2g

Palacos®R+G 0.5g

Palacos® 1g Vanc

Palacos® 2g Vanc

120

100

80

60

40

20

0Co

mp

ress

ive

Str

en

gth

(M

Pa)

SPECTRUM® GV 2g

Palacos®R+G 0.5g

Palacos® 1g Vanc

Palacos® 2g Vanc

Antibiotic Bone Cement Mechanical Performance ISO Standard5,7,8

SPECTRUM™ GV Bone Cement was tested in Lab A, Palacos R+G in Lab B, and Palacos 1g Vanc and Palacos 2g Vanc were tested in Lab C® ® ®

3500

3000

2500

2000

1500

1000

500

0

Be

nd

ing

Mo

du

lus

(MP

a)

SPECTRUM® GV 2g

Palacos®R+G 0.5g

Palacos® 1g Vanc

Palacos® 2g Vanc

70

60

50

40

30

20

10

0

Be

nd

ing

Str

en

gth

(M

Pa)

SPECTRUM® GV 2g

Palacos®R+G 0.5g

Palacos® 1g Vanc

Palacos® 2g Vanc

120

100

80

60

40

20

0Co

mp

ress

ive

Str

en

gth

(M

Pa)

SPECTRUM® GV 2g

Palacos®R+G 0.5g

Palacos® 1g Vanc

Palacos® 2g Vanc



3500

3000

2500

2000

1500

1000

500

0

Be

nd

ing

Mo

du

lus

(MP

a)

SPECTRUM® GV 2g

Palacos®R+G 0.5g

Palacos® 1g Vanc

Palacos® 2g Vanc

70

60

50

40

30

20

10

0

Be

nd

ing

Str

en

gth

(M

Pa)

SPECTRUM® GV 2g

Palacos®R+G 0.5g

Palacos® 1g Vanc

Palacos® 2g Vanc

120

100

80

60

40

20

0Co

mp

ress

ive

Str

en

gth

(M

Pa)

SPECTRUM® GV 2g

Palacos®R+G 0.5g

Palacos® 1g Vanc

Palacos® 2g Vanc



Antibiotic Bone Cement Mechanical Performance5,7,8

SPECTRUM® GV Bone Cement was tested in Lab A, Palacos R+G in Lab B, and Palacos 1g Vanc and Palacos 2g Vanc were tested in Lab C

ISO Standard

Antibiotic Bone Cement Mechanical Performance5,7,8

Long Stem Large

Long Stem Medium

Long StemSmall

Short StemLarge

Short StemMedium

Short Stem Small

HIP MODULARITYThe REMEDY® Hip Spacer is part of the treatment foreseen in a two-stage procedure

performed in the event of permanent prosthesis infection. The REMEDY® Hip Spacer

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 REMEDY® Hip Spacer and replace it with a permanent hip joint implant.

60mm

54mm

46mm

REMEDY® MODULAR STEMS

REMEDY® Hip Spacers:• Single-use medical

devices/ethylene

oxide sterile

• Formed with bone

cement (PMMA)

and gentamicin

Stainless steel rods within stems provide added mechanical strength

Stainless steel rod reinforces the femoral stem

REMEDY® MODULAR HEADS

Head sizes interchangeable with

stems for surgical flexibility

uu

u

• The first available pre-formed PMMA, antibiotic eluting acetabular cup spacer

• Cup articulates with head to improve device stability and mitigate dislocations

• Helps protect acetabular integrity during staged procedures

REMEDY®

ACETABULAR CUP

11

REMEDY® & REMEDY SPECTRUM® GV HIP SYSTEM

40mm*

Variable head and neck design allows desired placement and positioning up to 17mm

54mm OD

48mm OD

*40mm head size only available in REMEDY SPECTRUM® GV System

12

STEP 8Using UNITE® AB Bone Cement, or SPECTRUM® GV Bone Cement, 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: For additional fixation to the stem the remaining offset space and threads of the stem,

up to the femoral head, can be filled with antibiotic-loaded bone

cement. Cement may also be applied once seated within the femoral canal.

COVER CAP

REMEDY® & REMEDY SPECTRUM® GV HIP SPACER TECHNIQUE

STEP 2Using the REMEDY® Spacer Trials,† select the appropriate size femoral stem, femoral head, and acetabular cup (if applicable).†† If using the acetabular cup, check the dimensions of the native acetabulum using the TRIAL end of the REMEDY® Acetabular Cup Trial/Handle.

STEP 3

With the appropriate head size selected, open the packages and remove the monomer vial.

STEP 6

STEP 7Remove 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.

WARNING: The head must be seated past the safety colored line marked on the stem thread.

On the trials, the colored line is designated with a missing thread on the stem neck.

STEP 9Insert the stem (with head properly affixed) into the canal. Perform a final reduction to assess joint stability and implant alignment.

STEP 1In accordance with the existing total joint manufacturer’s technique, prepare the infected joint space by first removing the prosthesis and any PMMA cement, if present, and any hardware (which may be a reservoir of infection).

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.

If implanting without an acetabular cup, proceed to Step 6.

Using UNITE® AB Bone Cement, or any FDA-cleared gentamicin-based PMMA, apply cement to the native acetabulum and the backside of the REMEDY® Acetabular Cup. Place the acetabular cup into the acetabulum by hand.

STEP 4Using the IMPLANT end of the REMEDY® Acetabular Cup Trial/Handle, position the cup spacer into the desired orientation within the native acetabulum.

Insert and seal the hole with the plastic cover cap supplied. Shake the head for 60 seconds to ensure all of the threads within the head are wet with monomer.

TRIALS

STEP 5With the acetabular cup in place, a final trial reduction may be performed using the trial stem and head components to confirm or correct implant positioning, noting the chosen off-set with the head seated past the missing thread on the stem neck.

Break the vial open and pour all the monomer into the screw opening of the head.

Note: When placing the components with cement, do not impact with a mallet. It is recommended to use the trial/handle with hand pressure only.

Note for spacer removal: Prior to implantation of a new permanent THR, the operative area should be rigorously irrigated and rinsed after device extraction to remove all cement debris prior to implantation of the permanent prosthesis or other surgical pro-cedures (e.g., resection arthroplasty, etc.).

†The REMEDY® SPACER TRIALS can be used with the REMEDY® & REMEDY SPECTRUM® GV Hip Spacers.

††The SPECTRUM® GV Bone Cement is indicated for the fixation of a REMEDY SPECTRUM® GV Spacer to the host bone.

REMEDY®AND REMEDY SPECTRUM® GV HIP SPACER

2 1

REMEDY® AND REMEDY SPECTRUM® GV

MODULAR HEAD

6

7

3

5

4

8 3

4

7

5

6

REMEDY® AND REMEDY SPECTRUM® GV MODULAR LONG STEM

8

REMEDY® ACETABULAR

CUP

2

1

HIP SPECIFICATIONS

REMEDY®AND REMEDY SPECTRUM® GV

MODULAR STEM

3

13

Hip Component Description

REMEDY® ACETABULAR CUP 40mm ID/48mm OD

REMEDY® ACETABULAR CUP 46mm ID/54mm OD

REMEDY SPECTRUM® GV Femoral Head – 40 mm

REMEDY® & REMEDY SPECTRUM® GV Femoral Head – 46 mm



REMEDY® & REMEDY SPECTRUM® GV Femoral Stem - Small

REMEDY® & REMEDY SPECTRUM® GV Femoral Stem - Medium

REMEDY® & REMEDY SPECTRUM® GV Femoral Stem - Large

REMEDY® & REMEDY SPECTRUM® GV Femoral Long Stem - Small

REMEDY® & REMEDY SPECTRUM® GV Femoral Long Stem - Medium

REMEDY® & REMEDY SPECTRUM® GV Femoral Long Stem - Large

51

58.5

40

46

54

60

27.5

31

35

42.3

50.9

57.3

111

112

117

227

227

231

.27

0.3

—

0.9

1.6

2.3

0.5

0.6

0.7

0.6

0.8

0.9

(MM)

1 2 3 4 5 6 7 8

REMEDY SPECTRUM®GV Catalog #

—

—

GVHDXS

GVHDSM

GVHDMD

GVHDLG

GVSTSM

GVSTMD

GVSTLG

GVLSSM

GVLSMD

GVLSLG

Gentamicin Base (g)

10

11

11.5

10

11

11.5

16.5

21.7

24

16.5

21.7

24

11.3

15.5

16.5

11.3

15.5

16.5

35.6

35.6

35.6

35.6

35.6

35.6

17

17

17

17

17

17

REMEDY SPECTRUM GV

Gentamicin Base (g)

Vancomycin Base (g)

—

—

.46

0.9

1.6

2.3

0.5

0.6

0.7

0.6

0.8

0.9

—

—

.46

0.9

1.6

2.3

0.5

0.6

0.7

0.6

0.8

0.9

REMEDY

RHACXS

RHACSM

—

RHHDSM

RHHDMD

RHHDLG

RHSTSM

RHSTMD

RHSTLG

RHLSSM

RHLSMD

RHLSLG

REMEDY®Catalog #

® ®

47

54

REMEDY® SHOULDER SYSTEM

40mm

45mm

50mm

Large Stem

Medium Stem

Small Stem


SHOULDER MODULARITY

REMEDY® Shoulder Spacers:• Single-use medical

devices/ethylene

oxide sterile

• Formed with bone

cement (PMMA)

and gentamicin

REMEDY® MODULAR

STEMS

uuu

Variable head and neck design allows desired placementand positioning up to 9mm

REMEDY® MODULAR

HEADS Head sizes interchangeable

with stems for surgical flexibility

The REMEDY® Shoulder Spacer is part of the treatment foreseen in a two-stage procedure performed in the event

of permanent prosthesis infection. The REMEDY® Shoulder Spacer 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 REMEDY® Shoulder Spacer and

replace it with a permanent shoulder joint implant.

Stainless steel rod reinforces the humeral stem

14

REMEDY® SHOULDER SPACER TECHNIQUE

STEP 1In accordance with the existing shoulder manufacturer’s tech-nique, prepare the infected joint space by first removing the shoulder prosthesis and any PMMA cement, if present, and any hardware that may be a reservoir of infection.

STEP 2Using the Shoulder Spacer Trials, select the appropriate size humeral stem and humeral head components.

STEP 3

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.

STEP 4Remove 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.

WARNING: The humeral head must be seated past the colored Safety Line marked on the stem thread.

On the stem trials, the colored line is designated with a missing thread on the stem trunnion.

STEP 6Insert the humeral stem (with head properly affixed) into the canal to the desired position.

Continue to prepare the joint space with aggressive debridement, pulse lavage and other standard practices for preparing the infected joint space.

COVER CAP

Insert and seal the hole with the plastic cover cap supplied with the humeral head. Shake the head for 60 seconds to ensure all of the threads within the head are wet with monomer.

TRIAL

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.

STEP 5Using UNITE® AB Bone Cement, or other FDA cleared gentamicin-based PMMA, 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.

Note: For additional fixation to the stem the remaining offset space and threads of the stem, up to the humeral head, can be filled with gentamicin-loaded bone cement. Cement may also be applied once seated within the humeral canal. 15


SHOULDER SPECIFICATIONS

REMEDY® MODULAR

HUMERAL HEAD

REMEDY® MODULAR

HUMERAL STEM

72

1

5

3

4

68

REMEDY®

SHOULDER SPACER

1-800-OSTEO-XL 901-453-3141 [email protected] OsteoRemedies.com

OsteoRemedies, LLC 6800 Poplar Avenue Suite 120 Memphis, TN 38138

REMEDY, REMEDY SPECTRUM, OsteoRemedies and the corporate mark are trademarks of OsteoRemedies, LLC • REMEDY and SPECTRUM are manufactured by OsteoRemedies, LLC©2020 • MKT000 • 6-20-V19

1 Minelli, E. Bertazzoni, et al., 2011. Anaerobe 17(6), 380-383. 2 Trampuz, A., et. al., 2005. Swiss Med Weekly. 135(17-18): 243-51. Review. 3 Watanakunakom, et al., 1980 Journal of Antimicrobial Chemotherapy 6,

785-791. 4 Watanakunakom, et al., 1982. Antimicrobial Agents and Chemotherapy,

903-905.

5 For complete data and associated risks reference the REMEDY

SPECTRUM® GV Hip IFU. In a review of 22 patients, clinical

effectiveness was defined as the absence of 2 or more positive

cultures at the time of reimplanation. Patients should be

monitored for ototoxicity and nephrotoxicity while under-going

treatment for PJI.

6 Prostalac HDE H000004 Data. 7 Bishop, A., et al., 2018. Data in Brief. 20. 14-19. 8 Carann, R. et al., 2013. World Journal of Orthopaedics.

9327(36).

Description

40

45

50

25

25

25

101

116

131

7

10.5

14

9.4

12.6

15.8

0.5

0.5

0.6

0.1

0.3

0.5

7.8

10.5

14

(MM)

1 2 3 4 5 6 7 8 Gentamicin

Base (g)

REMEDY Modular Humeral Head 40mm



REMEDY Modular Humeral Stem - Small

REMEDY Modular Humeral Stem - Medium

REMEDY Modular Humeral Stem - Large

19

19

19

9

9

9

Catalog #

RSHHSM

RSHHMD

RSHHLG

RSHSSM

RSHSMD

RSHSLG

®

®

®

®

®

®

lution · femoral component 54mm (small) tibial component 60mm (small) tibial wedge 60mm - width...

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