TRAUMACEM™ V+ A u g m e n t a t i o n S y s t e m

www.depuysynthes.com

©DePuy Synthes 2017. All rights reserved. DSUS/TRM/0417/1436 7/17

Enhanced Implant Fixation in Patients with Poor

Bone Quality

Sources:

1. DePuy Synthes test data on file, Windchill 0000268245.

2. Hofmann L, Zderic I, Hagen J, Agarwal Y, Scherrer S, Weber A, Altmann M, Windolf M, Gueorguiev B. Biomechanical effect of bone cement augmentation on the fixation strength of TFNA blades and screws. Presented at 22nd Congress of the European Society of Biomechanics. 10-13 July 106. Lyon, France.

3. Kammerlander C, Gebhard F, Meier C, et al. Standardized cement augmentation of the PFNA using a perforated blade: A new technique and preliminary clinical results. A prospective multicenter trial. Injury. 2011;42(12):1484-1490.

4. Kammerlander C, Doshi H, Gebhard F, Scola A, Meier C, Linhart W, Garcia-Alonso M, Nistal J, Blauth M (2014). Long-term results of the augmented PFNA: a prospective multicenter trial. Arch Orthop Trauma Surg 134(3):343-9.

5. Gu Q, Koenig L, Mather RC, 3rd, Tongue J. Surgery for hip fracture yields societal benefits that exceed the direct medical costs. Clinical orthopaedics and related research. 2014;472(11):3536-3546.

6. Wu D, Ren G, Peng C, Zheng X, Mao F, Zhang Y. InterTan nail versus Gamma 3 nail for intramedullary nailing of unstable trochaneteric fractures. Diagn Pathol. 2014 Oct 1;9:191.

7. DePuy Synthes test data on file, Windchill 0000267150.

© DePuy Synthes 2017. All rights reserved.DSUS/TRM/1014/0269(2) 4/17 DV

To learn more about the future of hip fracture treatment, contact your DePuy Synthes Sales Consultant or visit: www.tfnadvanced.com

Indications for Use: TFN-ADVANCED® Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for: stable and unstable pertrochanteric fractures; intertrochanteric fractures; basal neck fractures; combinations of pertrochanteric, intertrochanteric, and basal neck fractures.

The Long Nail is additionally intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused for the following indications: subtrochanteric fractures; pertrochanteric fractures associated with shaft fractures; pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions; long subtrochanteric fractures; proximal or distal non-unions, malunions and revisions.

Both the short and long TFNA Systems are additionally indicated for use with cleared, polymethylmethacrylate (PMMA) bone cement that can be delivered through the fenestrated blade or screw via a cannula in skeletally mature adults with risk of cut-out or device instability due to poor bone quality.

Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

Please also refer to the package insert(s) or other labeling associated with the devices identified in this brochure for additional information.

CAUTION: Federal Law restricts these devices to sale by or on the order of a physician.

Some devices listed in this brochure may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada.

Not all products may currently be available in all markets.

The TFN-ADVANCED®

Proximal Femoral Nailing System is designed to advancehip fracture treatment with:

n Outcomes-based Design

n Reduced Procedural Complexity

n Comprehensive Surgical Options

www.depuysynthes.com

Synthes USA, LLC 1101 Synthes AvenueMonument, CO 80132

Manufactured or distributed by:Synthes USA Products, LLC 1302 Wrights Lane EastWest Chester, PA 19380

To order (USA): 800-523-0322 To order (Canada): 855-946-8999

Note: For recognized manufacturer, refer to the product label.

The TFN-ADVANCED Proximal Femoral Nailing System is designed to advance hip fracture treatment with:n Outcomes-based Design

n Reduced Procedural Complexity

n Comprehensive Surgical Options

To learn more about the future of hip fracture treatment, contact your DePuy Synthes Sales Consultant or visit: www.tfnadvanced.com

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TRAUMACEM™ V+ A u g m e n t a t i o n S y s t e m

The TRAUMACEM™ V+ Augmentation System. The first and only polymethylmethacrylate (PMMA) cement with specific indications for augmentation of a trauma device, allowing surgeons to inject a controlled amount of cement into the femoral head in patients with poor bone quality, reducing the risk of cut-out.

The TRAUMACEM V+ Augmentation System is exclusively offered for use with the TFN-ADVANCED® Proximal Femoral Nailing (TFNA) System and builds on the list of comprehensive surgical options that the TFNA System offers.

Demonstrated resistance to cut-out

n Augmented head elements have up to a 244% increase in resistance to cut-out in biomechanical testing.2

Enhanced surgical flexibility

n Sterile packed design allows for intra-operative decision to inject augmentation, after head element placement, for at risk patients.

Early clinical results

n Zero cut-outs and no unexpected head element migration observed in the first two prospective multicenter trials when using augmentation.3,4

Disclaimer: Bench test results may not be indicative of clinical performance.

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TRAUMACEM™ V+ A u g m e n t a t i o n S y s t e m

HIP FRACTURES ARE COMMON IN THE ELDERLY WITH OSTEOPOROTIC BONE,

AND INCIDENCE IS EXPECTED TO RISE.5

CUT-OUT IS A LEADING CONTRIBUTOR OF CLINICAL COMPLICATIONS, AND HAS BEEN REPORTED AS HIGH AS 8%6, PRIMARILY LINKED TO THE PATIENT’S BONE QUALITY.

Healthy Bone Osteoporotic Bone

Pre-Operative

Pre-Operative

Post-Operative

Post-Operative

Case 1: 72-year old female > AO 31-A2.2 Fracture : Unstable pertrochanteric fracturen This patient presented with osteoporosis and the surgeon elected to use the TRAUMACEM V+ Augmentation

System. After insertion of the TFNA Helical Blade, peri-implant PMMA augmentation was applied to enhance bone anchorage of the implant. TRAUMACEM V+ Augmentation System was used in this patient due to their age and bone quality.

Case 2: 87-year old female > AO 31-A2 Fracture : Unstable pertrochanteric fracturen This patient had an osteoporotic varus deformity of the femoral neck and shaft. In order to salvage the suboptimal

placement of the TFNA Helical Blade, the head element was augmented to protect against cut-out.

CUT-OUT AS A CLINICAL COMPLICATION CLINICAL CASES

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TRAUMACEM™ V+ A u g m e n t a t i o n S y s t e m

DEMONSTRATED RESISTANCE TO CUT-OUTBy injecting a recommended 3 mL of TRAUMACEMTM V+ Injectable Bone Cement through cannulated implants and instruments into the femoral head, the risk of cut-out may be reduced as demonstrated through biomechanical testing.

Biomechanical test data shows that there is a significant increase in stability using the TRAUMACEM V+ Augmentation System.1,2

Fenestrated TFNA Helical Blades & TFNA Screws

Cement injected through head element into the femoral head using a side opening cannula for direct surgeon control

Withstand higher loads...

n Whether the head element is in the center or off-center position, augmented head elements withstand higher loads prior to failure.

...for more cycles

n Augmented constructs resist varus collapse for more cycles than non-augmented constructs.

Disclaimer: Bench test results may not be indicative of clinical performance.

20k

10k

0

+346%

+271%30k

Center

Non AugmentedTRAUMACEM V+ Injectable Bone Cement

CY

CLE

S TO

5°

VA

RU

S C

OLL

APS

E

Off Center

4500

4000

3500

3000

2500

2000

1500

1000

500

0Center

Non AugmentedTRAUMACEM V+ Injectable Bone Cement

+131%

+244%

HEAD ELEMENT POSITION

LOA

D A

T FA

ILU

RE

(N)

Off Center

HEAD ELEMENT POSITION

7 8

TRAUMACEM™ V+ A u g m e n t a t i o n S y s t e m

ENHANCED SURGICAL FLEXIBILITY

Ready when needed

n Comprised of single use sterile implants and instruments, TRAUMACEM V+ Augmentation System enables surgeon choice following head element placement.

Controlled injection

n Inject a controlled amount of cement into the femoral head using a uniquely designed injection cannula and fenestrated head element, providing strong implant fixation.

Head element design enables intraoperative decision making

n Fenestrated head elements perform equivalent to solid head elements, thus enabling choice of augmentation with a single implant design.

Optimized cement

n Initial viscosity of TRAUMACEM V+ Injectable Bone Cement allows for cement injection immediately after mixing with no wait time.

n Cement working time begins immediately and lasts for up to 27 minutes at room temperature (68˚F).

n Radiopaque design enables visualization under fluoroscopy to detect cement flow.

Exclusively for TFNA System

n TRAUMACEM V+ Augmentation System is cleared exclusively for the TFNA System.

3000

2500

2000

1500

1000

500

TFNA Non-Fenestrated

Head Element

TFNA Fenestrated

Head Element

LOA

D A

T FA

ILU

RE

(N)7

10

TRAUMACEM™ V+ A u g m e n t a t i o n S y s t e m

EARLY CLINICAL RESULTS In two prospective multicenter trials when using augmentation:3,4

PRODUCT ORDERING INFORMATION

TRAUMACEM V+ Injectable Bone Cement, Sterile (07.702.040S)

n 1 x TRAUMACEM V+ mixer with cement powder and sterilization lid

n 1 x Monomer glass ampoulen 1 x Cement mixing and transferring lid

TRAUMACEM V+ Syringe Kit, 4 x 1 mL, 2 x 2 mL, Sterile (03.702.150S)

n 4 x Blue 1 mL syringesn 2 x White 2 mL syringesn 1 x One-way stopcock

TRAUMACEM V+ Injection Cannula, for TFNA System, sterile (03.702.121S)

n 1 x Side-opening cannula, with Luer-lockn 1 x Plunger

Additionally required:1-2 Syringes (6-10 mL) with Luer-lockSaline solutionRadiographic contrast agent

Studies of the follow-up X-rays showed no unexpected blade migration such as cut-out or cutting through and no loosening of the blade in this series.4

The augmentation of the blade gives the fixation construct much more stability due to a larger bone-implant interface.4

Zero cut-outs

n 0 cut-outs and no unexpected head element migration observed.

Author’s conclusions on augmentation

n Augmentation was used with the Proximal Nail Antirotation (PFNA) System* with the authors concluding:

No clinical complications related to the cement

n Clinically proven surgical technique reduces risk of cement extravasation into joints.

n 0 reported occurrences of heat- induced necrosis.

A safe and user-friendly tool for pertrochanteric fracture fixation. It prevents blade migration within the head-neck fragment and leads to good functional results.3

9 *The PFNA System is a DePuy Synthes proximal femoral nail available outside the United States.