Competitive Analysis

ATTUNE®
KNEE SYSTEM
vs.

The Zimmer® Persona® Knee

FOR SALESFORCE USE ONLY

Topic

1 HISTORY

FOR SALESFORCE USE ONLY

Topic 1: History

ATTUNE® KNEE SYSTEM:

From the beginning, the focus of the ATTUNE® Knee System was improving implant
performance and patient satisfaction. Data show that close to 15–20 percent1 of
patients are dissatisfied after TKA. To address the unmet clinical needs of these
patients, DePuy Synthes Joint Reconstruction designed the ATTUNE Knee System.
The ATTUNE Knee set out to address the needs of these unmet patients. To achieve
this, the following system goals were established:
· Improved function through stability and motion
· Improve patient fit
· Improve patellofemoral function
· Improve design and materials for implant durability
· Advance the surgical process for implant positioning and OR efficiency.
We accomplished this through:
· Six years of research and development work.
· Partnerships with several top research institutions around the world.
· The creation of advanced TKA testing, simulators, and modeling to help fully
understand what it would take to improve performance in TKA.
· Advanced research included computational modeling at the University of
Denver & DePuy Synthes Joint Reconstruction and weight bearing cadaveric
testing at the University of Kansas.
· Over 10,000 design hours were spent by 35 surgeons, in specialized sub
teams, to test, validate, and improve the design of the ATTUNE Knee through
multiple cadaveric and intra-operative evaluations.

vs.

PERSONA™
The Persona™ Knee System brings together two contemporary knee systems
which offer surgeons different product attributes and technologies within the
Zimmer® TKA portfolio. The Persona™ system combines the Natural-Knee®
tibial base design, NexGen® High Flex femoral component, Trabecular MetalTM,

For Salesforce Use Only

 and Vivacit-E® polyethylene9 technologies into one system, with additional
component sizes than were offered in the previous systems. Additional aspects
of the system include:
· Inventory reduction by consolidating systems and allowing for a knee system
that fits into the company strategy of personalized solutions through additional
sizing options.
· PersonaTM femoral components are compatible with NexGen® tibial inserts,
meaning the PersonaTM femoral and insert articulating designs are very similar
to NexGen®.9
· Advanced computational modeling was not used to develop PersonaTM. The
company has just begun work in this area, which was published at ORS in
2013, “Thus this (robotic simulator) ZeBRA system can be used to evaluate
potential implant designs and will help facilitate the development of more
natural feeling implant designs that will give patients the potential to return to
their pre-surgery quality of life.”2 However, this research was not used in the
development of PersonaTM.

For Salesforce Use Only

Topic
FEMORAL
2 GEOMETRY &
KINEMATICS
Introduction
The native knee provides high stability for early flexion
activities and rotational freedom in deeper flexion activities.
Many of the contemporary TKR implant systems incorporate
“J-curve” designs to address this. These designs provide one
radius of curvature for early flexion stability and a second
radius of curvature for deeper flexion activities. However,
when these traditional designs move from the first radius to
the second radius there is a sudden change in kinematics and
a sudden drop in implant conformity/stability.

FOR SALESFORCE USE ONLY

Topic 2: Femoral Geometry & Kinematics

ATTUNE® KNEE SYSTEM:

· The ATTUNE GRADIUS™ Curve has been designed with the goal of
more closely resembling the kinematics of the native knee.3,5
· The ATTUNE GRADIUS Curve has been designed with the goal VIEW GRAPH
of reducing anterior sliding of the femoral component on the
polyethylene tibial insert by gradually reducing the radius of curvature
from high stability in extension to rotational freedom in flexion.3, 5
· Data has shown that the tension of the collaterals change throughout
flexion.4 The ATTUNE Knee has been designed with the goal of
working in harmony with changing MCL & LCL tension.4

vs.

PERSONA™
· In order to be compatible with legacy NexGen® tibial inserts, the
Persona™ CR and PS femoral components have similar femoral
“J-curve” designs as their NexGen® predecessors.
· Persona™ CR has the same basic “J-curve” design as the NexGen® CR VIEW GRAPH
knee in order to have compatibility with the NexGen CR inserts. The
®

Persona™ PS Knee has the same basic “J-curve” design as NexGen®

LPS Flex in order to have compatibility with LPS Flex inserts.9
· The NexGen® knee has been shown to have paradoxical anterior
sliding due to a significant radius change when going from a broad
distal radius to a smaller posterior radius.3,5 This will be very similar
with Persona™.
· Designs that feature sudden changes in radii experience abrupt
changes in kinematics and axial rotation.3,5
· The chart below documents the abrupt decrease in conformity of
the NexGen® LPS Flex (which shares a very similar conformity ratio as
Persona™). The sudden change in conformity ratio negatively affects
kinematics between 15 degrees to 30 degrees flexion and represents
more than 60 percent reduction in conformity allowing for instability
or paradoxical anterior sliding.5

0° 15° 30° 60° 90°

NexGen® LPS Flex 0.87 0.87 0.33 0.33 0.33

For Salesforce Use Only

 POSTERIOR
Topic STABILIZED (PS)
3 KNEES
Introduction
Historically, PS knee designs have under performed their
cruciate retaining (CR) counterparts. This is proven by data
from the Australian Registry.
Revisions/100
Femoral Tibial
N Revised N Total Obs. Years Obs. Yrs
Component Component
(95% CI)
NexGen® CR Nexgen 80 3553 25417 0.31 (0.25, 0.39)
NexGen® CR Flex Nexgen 98 7660 22489 0.44 (0.35, 0.53)
NexGen® LPS Nexgen 163 4737 30007 0.54 (0.46, 0.63)
NexGen® LPS Flex Nexgen 459 17089 61586 0.75 (0.68, 0.82)

Some design elements to consider for improving the

performance of PS knees may include: cam/spine
engagement, velocity of the cam as it engages with the tibial
spine, shape of the tibial spine and how it addresses contact
pressure and location of forces, and intercondylar box size
and its corresponding effect on patellar crepitus.

FOR SALESFORCE USE ONLY

Topic 3: PS Knees

ATTUNE SOFCAM™ CONTACT:

· The ATTUNE PS knee is designed to provide smooth
cam/spine engagement, gradual femoral rollback,
and stability in flexion.
· The ATTUNE GRADIUS Curve on the PS Knee
attenuates anterior sliding. This reduces contact
velocity of the cam and spine.7
· When contact is made, there is no abrupt change
in kinematics as seen with competitive systems.7 As
the knee rolls back, the forces are transferred to the
most distal aspect of the tibial spine.7
· The femoral box is able to be minimized by always
matching the femoral component to the tibial insert. The chart above shows that the ATTUNE System
has significantly lower cam/spine engagement
· The ATTUNE Knee System has made significant velocity than NexGen®. The Persona™ femoral
design is very similar to NexGen® in order to have
design improvements to reduce anterior knee pain, compatibility with NexGen® inserts.
including patella crepitus versus other designs. These
include lengthening the trochlear groove, matching
the femur to insert, blending transitions into the box
region, providing a medialized dome patella, and
allowing the 3rd joint space (patellofemoral joint) to
be precisely balanced.

vs.

PERSONA™ PS KNEE:
· The Persona™ PS design has a similar “J-curve” design as NexGen®. NexGen® has been
shown to have the highest tested femoral cam engagement velocity into the tibial spine
during flexion (when compared to the ATTUNE Knee & Triathlon®). This high velocity
may increase post damage and cause abrupt changes in kinematics after contact.7
· Persona™ does not always match the insert to the femur. Therefore, kinematics are
compromised with Persona™.
· Persona™ does not have proportional boxes widths for each femoral component size.
Persona™ box sizes break down in the following increments in order to allow femoro-
tibial mismatch throughout their sizing line. They have the same box sizes for femurs
1-2, 3-5, 6-9, and 10-12.9

For Salesforce Use Only

 INSERT TO FEMUR
MATCHING &
Topic
TIBIAL BASE DESIGN
4 Introduction
Many contemporary fixed bearing implant designs require
matching the size of the tibial base plate to the tibial insert. This
was based on fixed bearing tibial base designs which locked the
insert into the peripheral capture of the tray. These designs did
not allow the insert to be upsized or downsized relative to the
tray. Where upsizing or downsizing was required to get optimal
patient fit (femur to insert), sub-optimal kinematics resulted due
to a larger femur articulating on a smaller insert or vice-versa.
Internal DePuy Synthes Joint Reconstruction data show that in
our own total knee systems approximately 50 percent of the
time the tibial insert is upsized or downsized versus the femoral
component,8 resulting in a compromise between the insert and
femur’s conformity and kinematics. In order to address a better
patient fit and provide optimized kinematics, a new locking
mechanism was required.
Another design aspect to consider is how knee systems
address micromotion and wear. Industry data show that
it is advantageous to have a highly polished surface finish
and improved locking mechanism to further improve the
performance of knee constructs.10, 11

FOR SALESFORCE USE ONLY

Topic 4: Insert to Femur Matching and Tibial Base Design
CR STABILITY: FULL EXTENSION
450

ATTUNE LOGICLOCK™ TIBIAL BASE:

ATTUNE CR Insert
400
SIGMA Curved Insert
350 SIGMA Curved + Insert
Femur to Insert Kinematics
A/P FORCE (N)

300
· With
250 the ATTUNE Knee System, the femoral component always matches the tibial
insert.
200 Without this precise matching, technologies like the ATTUNE GRADIUS Curve and
SOFCAM Contact would be compromised to accommodate an upsized or downsized
150
insert. Also, the box width of our PS femoral component would need to increase
100
throughout the size range to accommodate for muliple insert options.
50
· The0insert to femur matching of the CR FB and CR RP inserts allows for cruciate sacrificing
applications.
0 1 Both
2 of3these4 constructs
5 6 have
7 been8 approved
9 10 for 11 this
12application
13 14 by 15the16 17
FDA. Data show that because the femur and
A/P insert match,(mm)
TRANSLATION better A/P stability is achieved,
therefore negating the need for an anterior stabilized design, like the SIGMA® Curved+.

CR STABILITY: 15º
450
ATTUNE CR Insert
400
SIGMA Curved + Insert
350
A/P FORCE (N)

300
250
200
150
100
50
0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17
A/P TRANSLATION (mm)

Design/Material:
CR STABILITY: 90º 400 R
10

· The
450ATTUNE Knee tibial base plate is highly polished 350 RT 9

to400
help reduce backside wear.10,11 300
7
250
6
350ATTUNE Knee tibial base plate only allows 16
· The
RT (°)
R (µm)

200 5
A/P FORCE (N)

300
microns of micromotion, the lowest amount in 150 4

3
the
250industry.
12 100
2
50
1
200 0 0
Shape: ATTUNE® P.F.C. Advance® NexGen® Duracon® Optetrak® Journey™ Scorpio®
150 DePuy
Synthes
SIGMA® Wright Zimmer® Stryker Exactech® Smith & Stryker®
DePuy Medical Nephew®
Joint Synthes
· The
100ATTUNE Tibial Bases are symmetric in shape
Recon- Joint
struction Recon-
struction
R = (AP2 + ML2)0.5; RT = rotation.

and50are available in 10 sizes. In vivo data show that

with0 a similar size range; symmetric trays show ENLARGE
vs. less M/L
0 overhang
1 2 than
3 asymmetric
4 5 6trays.7
14,15,16
8 9 10 11 12 13 14 15 16 17
A/P TRANSLATION (mm)
For Salesforce Use Only
PERSONA™ TIBIAL BASE:
Femur to Insert Kinematics
· Each size Persona™ femoral component can be used with a number of different
insert sizes. This leads to sub-optimal conformity/stability conditions in about 50
percent of cases.8
· Persona™ requires a different insert for cruciate sacrificing applications.
· Persona™ requires a larger box resection for a given femoral size, because the box must
accommodate an insert up to two sizes bigger.

Design/Material:
· Polished titanium.
· Improved locking mechanism versus NexGen® (NexGen® was five times worse than the
SIGMA I2 locking mechanism for micromotion).16
· No precoat option.

Shape:
· 9 tray sizes and asymmetric in shape to fit
“personalized solution” marketing.
· Extensive analysis of DePuy Synthes Joint
Reconstruction’s TRUMATCH® Personalized
Solutions data show the lateral side of tibia is
only about 5 percent shorter than the medial
side after resection. The Persona™ design has
a medial side that is between 10.7 percent and
12.69 percent longer than the lateral side.9
· Data show that more size offerings for better
patient fit is more important than having
an asymmetric shape for tibial coverage.14-16
The ATTUNE Knee System offers 10 symmetric tibial sizes versus Persona™ with 9
asymmetric sizes. When compared to SIGMA FB, and it’s offering of 7 symmetric
tibial base sizes, SIGMA’s coverage was comparable at 94.9 percent and Persona™
at 95.6 percent.
· Several publications show better coverage with a symmetric tray versus an asymmetric
tray when equivalent sizes are available.14-16

For Salesforce Use Only

 · Due to its ability to be rotated for best tibial coverage, RP has been shown to provide
better coverage than symmetric or asymmetric fixed bearing tibial trays.18
· Asymmetric trays have been shown in vivo to have an incidence of posterior-medial
overhang of about 15 percent. The incidence for symmetric trays is 1-2 percent.16
Posterior-lateral overhang also increases in vivo.16 (Zimmer® Persona™ data show better
tray coverage without overhang has not been validated in vivo).17
· The Persona™ asymmetric tibial base has a variable offset keel which is size
dependent and varies from 1 mm of offset on the smaller sizes to 4 mm on the larger
sizes.9 The Persona™ tibial base incorporates the design elements of the Natual Knee®,
which did not have a keel.
· Tibial and femoral rotation of the native knee is widely variable. The tibia has been
shown to be rotated up to 11 degrees externally to 4 degrees internally versus the
femur.19 Because asymmetric tray shape drives the position/rotation of the tray this may
lead to a greater kinematic conflict in PS knees.

For Salesforce Use Only

Topic PATELLAR
5 TRACKING

Introduction
Data show that up to 20 percent of patients are dissatisfied
after TKA with more than 50 percent of those patients
dissatisfied due to anterior knee pain.1 Improving the
interaction between the trochlear groove, the patella, and
the patient’s natural anatomy may help improve outcomes
after TKA.

FOR SALESFORCE USE ONLY

Topic 5: Patella Tracking

ATTUNE GLIDERIGHT™ ARTICULATION:

Trochlear Groove
· The trochlear groove has been lengthened to maximize contact between the patella and
femoral componets and may help mitigate crepitus.
· The groove has a variable Q-angle to accommodate varying patient height.
· The groove allows for the soft tissues to control the patella in lower flexion angles and
transition to trochlear control as the knee moves into flexion past 30 degrees (similar to
the native knee).20
· The anterior flange has been thinned out to minimize soft tissue impingement and to
allow more precise balancing of the third joint space.

Patella Design
· The shape of the patella and trochlear groove, helps reduce contact pressure and tilt.21,22
· The patella thicknesses increase in 0.5 mm increments.
· The patella implant features AOX™ Polyethylene technology.
· The apex of the patella has been medialized, helping to reduce patellofemoral issues.
vs.
PERSONA™ PATELLAR TRACKING:
Trochlear Groove
· The angle of the Persona™ trochlear groove is similar to NexGen®; however, the groove
has been thickened to eliminate the need for a sulcus cut. This thicker groove may lead to
overstuffing of the third joint space, one of causes of poor patellar tracking and anterior
knee pain. In comparison, the ATTUNE Knee trochlea is 2 mm thinner than Persona™.
· Patellar crepitus rates have been reported up to 24 percent with NexGen®. The Persona™ PS
design is very similar to NexGen®. As a result, Persona™ may incur similar results.23
· In one study, anterior knee pain after TKA was worse in NexGen® LPS than Insall-Burnstein
(IB).24 Persona™ may struggle with the same challenges based on its similarity to NexGen®.

Patella Design:
· The Persona™ patella is a centralized dome. This forces surgeons to compromise between
trying to obtain bony coverage while medializing the patella to improve tracking. Central
dome patella designs have shown to increase the amount of M/L tilt. This causes increased
stress on the lateral retinaculum and can lead to patellofemoral complications.25

For Salesforce Use Only

Topic

6 INSTRUMENTATION

Introduction
Instruments are key enablers to realize the benefits of an
implant system. If posterior condylar offset isn’t restored,
femoral rotation is incorrectly set, or gaps aren’t equally
balanced, patient outcomes will be less than desirable.
Instrument efficiency is critical for modern day TKA as recent
data show operating rooms perform at 70 to 80 percent of
their potential efficiency.35 Recent studies indicate the reasons
for such inefficiency include: instruments were incorrectly
assembled, staff is unfamiliar with a system, the surgeon
waiting on an instrument, and the wrong instrument being
handed to the surgeon.35

FOR SALESFORCE USE ONLY

Topic 6: Instrumentation

INTUITION™ INSTRUMENTS
Precise Control
· The INTUITION™ Instruments work with the implant sizing
options to enable better femoral component placement by
allowing the surgeon to fine tune the flexion space by 1.5 mm
through the +/- holes on the 4 in 1 block.
· The INTUITION Instruments allow for 1 mm adjustments on the
distal femur and tibial resections.
· Accommodate different surgical philosophies for soft tissue
management by offering measured resection or ligament
balancing approaches.

Designed Clarity
· The INTUITION™ Instruments were designed to be clear and
easy to use.
· High contrast markings make the instruments clear and easy
to read. Red actuators indicate which areas on the instruments
perform a key surgical function. Quick set/release functions
allow for single handed setting and removal of instruments.

Efficient Path
· The composite materials utilized in the INTUITION Instrument System in conjunction
with fewer instruments and trays, allows for over a 50 percent reduction in weight
versus other systems.
· Quick set/release functions allow the surgeon to set, lock and release settings with
one hand.

vs.

PERSONA™ INSTRUMENTS:
· Persona™ utilizes 17-4 stainless steel material for their instrumentation making them
heavier as compared to INTUITION Instruments using advanced composite materials.
With the use of stainless steel, the markings are hard to read and no color coding was
used for key indicators.9

For Salesforce Use Only

 · At launch, Zimmer® will not have gap balancing instruments. We estimate availablity
around Q3.
· The Persona™ measured sizing/rotation guide and femoral cutting blocks offer separate
anterior referencing and posterior referencing blocks. In addition, their measured sizer is
limited to only three and five degrees of rotation.
· Persona™ femoral cutting blocks do not provide a modular posterior capture to allow
assessment of flexion gap with a spacer block before making femoral cuts. Additionally, the
Persona™ femoral cutting block does not allow for fine tune up and down adjustment like
the INTUITION Instruments 4-in-1 cutting block does. The ATTUNE System with the posterior
removable capture allows for more precise control of flexion gap balancing.

For Salesforce Use Only

Topic

7 PATIENT FIT

Introduction
To accommodate a global population and provide optimal
patient fit for stability and motion, offering a breadth of sizes
and intra-operative flexibility is required in the introduction
of new total knee systems. The goal of femoral sizing is to
reduce M/L overhang while simultaneously being able to
appropriately restore both the posterior condylar offset and
the patellafemoral joint.

FOR SALESFORCE USE ONLY

Topic 7: Sizing

ATTUNE FEMORAL SIZING

· The ATTUNE Knee System offers 10 core sizes and 4 narrow sizes (14 size options).
· The CR knee has a distal condyle thickness of 9 mm and a posterior condyle thickness
of 8 mm. The PS knee has a distal condyle thickness of 9 mm and a posterior condyle
thickness of 9 mm. This additional 1mm of posterior condyle helps close down the flexion
space upon resection of the PCL.
· Narrow sizes have been specifically designed based upon anthropometric data.36 This data
shows that narrow sizes are beneficial for a specific band of implant sizes (3–6 for the
ATTUNE Knee System).

vs.

PERSONA™ FEMORAL SIZING

· Persona™ offers 10 core sizes and 11 narrow sizes.9
· The Persona™ CR knee has distal and posterior condyle thicknesses of 8 mm on sizes 1 & 2,
and 9 mm on sizes 3-12. The Persona™ PS knee has a distal condyle thickness of 8 mm on
sizes 1 & 2, and 9 mm on sizes 3-12, and it has a posterior condyle thickness of 9 mm on
sizes 1 & 2 and 10 mm on sizes 3-12.9
· The Persona™ sizing line is very similar to the combination of the NexGen® standard sizing
line and the NexGen® gender sizing line (this is seen on the chart below depicted by two
distinct blue rows of dots).9
· Persona™ has 2 mm increments in A/P per size (with the exception of their largest size,
which has a 4 mm change) while the ATTUNE System provides 3 mm increments in A/P. To
help provide optimal component placement and best patient fit, the ATTUNE knee provides
the ability to adjust the
4 in1 block by 1.5 mm. 90
ATTUNE
This provides more precise
Persona™
balancing of the flexion
80
space than Persona™.9
M/L (mm)

70

60

50 ENLARGE
45 50 55 60 65 70 75 80
A/P (mm)

For Salesforce Use Only 100

*Because Persona™ has an asymmetric tibia, A/P
ATTUNE
 80
Topic 7: Sizing

M/L (mm)
70
ATTUNE TIBIAL SIZING
· The ATTUNE Knee features 10 symmetric tibial sizes.

60
vs.

PERSONA™ TIBIAL SIZING

50
· Persona™
45
features
50
9 asymmetric
55
tibial60sizes.9 65 70 75 80
A/P (mm)

100
*Because Persona™ has an asymmetric tibia, A/P
ATTUNE measurements were taken from the medial side
(the longer of the two sides). The lateral side on
Persona™ average is 5 mm smaller than the medial side.9
90

80
M/L (mm)

70

60

50
30 35 40 45 50 55 60 65 70

A/P (mm)

For Salesforce Use Only

Topic 7: Sizing

ATTUNE INSERT SIZING

· The ATTUNE Knee System has 10 different M/L & A/P inserts designed to match 10 femoral
sizes (There are 14 femur sizes altogether, but the 4 narrow sizes have the same A/P as the
standard size).
· The ATTUNE System has 1 mm polyethylene increments for the first four thicknesses and
then 2 mm increments in the larger sizes.
· The smallest composite thickness of the insert and tray is 9 mm. 5 mm tibial insert paired
with a 4 mm tibial base.

vs.
PERSONA™ INSERT SIZING
· Persona™ CR & UC (Ultra Constrained) have 7 different M/L & A/P inserts designed to work
with 12 femoral sizes (There are 21 femoral sizes altogether, but 9 have the same A/P as
another femoral size).9
· Persona™ PS has 11 different M/L & A/P inserts designed to work with 12 femoral sizes
(There are 21 femoral sizes altogether, but 9 have the same A/P as another femoral size).9
· With the Persona™ system, one CR or UC insert can work with up to 9 different femoral
components. For the Persona™ PS one insert can work with up to 3 femoral components.
This mismatching creates compromises in conformity and kinematics.
· Persona™ has 1 mm polyethylene increments for the first five thicknesses and then 2 mm
increase in the larger sizes.9
· The smallest composite thickness of the insert and tray is 10 mm.9

Persona™ CR Femur Use On Persona™ Tibia

Persona™ Femoral Size

CR 1 2 3 4 5 6 7 8 9 10 11 12
A
1-2/AB 3-6/AB
Persona™ Tibial Size

B
C
1-2/CD 3-9/CD
D
E
3 - 11 / E F
F
G
7 - 12 / G H
H
J 9 - 12 / J

The chart above shows that a Persona™ CR insert can work with up to nine CR femurs. To accommodate this, the
insert must be made less conforming.9 A lack of conformity may lead to greater instability in early to mid-flexion.26

For Salesforce Use Only

Topic POLYETHYLENE
8 MATERIAL

Introduction
Current third generation polyethylene materials have
improved the wear and oxidative potential through
the use of annealing and remelting techniques. One of
the drawbacks of remelting is the slight reduction of
mechanical properties while the annealing process does not
eliminate all of the free radicals, leaving it susceptible to
oxidation. The remelting of third generation polyethylene
has been shown to eliminate free radicals. This extinguishes
the ability for oxidation. However, remelting can cause a
slight reduction in mechanical properties. To address some
of the drawbacks of third generation polyethylenes, a new
generation of polyethylenes with antioxidant stabilizers
were developed to maintain oxidative stability while
preserving mechanical properties.

FOR SALESFORCE USE ONLY

Topic 8: Polyethylene Material

AOX™ POLYETHYLENE
Design Process and Manufacturing
· DePuy Synthes Joint Reconstruction utilized comprehensive testing and validation
processes to develop AOX™ Polyethylene.
· AOX Polythylene contains COVERNOX™, an antioxidant that has been custom
synthesized and manufactured to pharmaceutical grade purity exclusively for DePuy
Synthes Joint Reconstruction.
· COVERNOX Antioxidant is a solid at room temperature. This allows the antioxidant to be
uniformly dispersed in the polyethylene resin powder prior to consolidation and irradiation.28

Wear Resistance and Mechanical Properties:

· AOX Polythylene is irradiated to a nominal dose of 8 Mrads. Due to the presence of an
antioxidant at the time of Gamma irradiation this provides an effective crosslinking dosage
of 5 Mrads.
· A higher dose of Gamma radiation would increase wear resistance in diminishing
increments while considerably decreasing mechanical properties.

Wear Properties The chart demonstrates the

law of diminishing returns once
polyethylene is irradiated past the
Perfect optimal effective dose. With each
Balance increasing Mrad of irradiation the
polyethylene becomes weaker.
This makes the polyethylene more
susceptible to breaks and fractures.

Mechanical Properties

INCREASING IRRADIATION DOSE AND CROSS LINKING

Testing: Numerous tests were performed on AOX to demonstrate and verify:

· Comprehensive biocompatibility.27
· Uniform distribution of the antioxidant within AOX Polyethylene.28
· Demonstrate that the antioxidant agent won’t leach out.29
· Long term oxidative stability and mechanical integrity.29
· Wear resistance benefit of crosslinked polyethylene.30
· The chemical identity of the by-products of gamma irradiation enabling the confirmation
vs. of toxicological risk mitigation.32

For Salesforce Use Only

PERSONA™ VIVACIT-E®:
Persona™ has employed a two polyethylene strategy, offering both
conventional and Vivacit-E®, a fourth generation antioxidant material.

Design Process and Manufacturing

· Vivacit-E® employs a grafting technique to help keep Vitamin E from leaching out. During
irradiation the molecular chains are broken, cross-linking/re-combination occurs, and
then the Vitamin E material is theoretically grafted into the polyethylene chains during
recombination (like a branch is grafted into a tree).34
· Data show an increase in irradiation can help improve the amount of Vitamin E material that is
kept from leaching out. However, at around 80 percent this plateaus. As a result 20 percent of
the remaining Vitamin E material may be allowed to leach out of the polyethylene.33
· There is no conclusive scientific evidence the grafting process is 80 percent effective. Data
demonstrate that Vitamin E is not leaching out of the polyethylene but it does not prove
that 80 percent has combined with the molecular chains.33
· Vivacit-E® utilizes a warm E-beam process. This allows allows more of the Vitamin E to be
retained. This is important because the Vitamin E is a liquid at room temperature. The longer
the sterilization process, the more Vitamin E may leech out of the polyethylene. Because
AOX Polyethylene is a solid at room temperature a faster sterilization process is not needed.

Wear Resistance and Mechanical Properties:

· Vivacit-E® utilizes three parts (3.0) per million of Vitamin E in Vivacit-E® while AOX
Polyethylene utilizes .075 parts per million of COVERNOX Antioxidant. AOX Polyethylene
does not go higher as there is not a benefit in reducing oxidation. Also there is no concern
about COVERNOX Antioxidant leaching out, negating the need for higher parts per million
anti-oxidant levels.34
· Vivacit-E® has roughly four times the amount of Vitamin E when compared to AOX
Polyethylene COVERNOX Antioxidant. Since Vitamin E is a monophenol, more is needed
to provide a similar level of stabilization, where COVERNOX Antioxidant is a polyphenol
and requires less to acheive adequate oxidative stability. In addition, Vivacit-E® has a higher
effective dose and since the antioxidant is present before irradiation, Vivacit-E® requires a
much higher sterilization dose (the more concentrated an antioxidant agent is, the more it
absorbs irradiation and mitigates its impact).33
· The Vivacit-E® dosage is over 20 Mrads due to the high parts per million level of antioxidant.
This high dosage could lead to issues with the polyethylene’s mechanical integrity.34

For Salesforce Use Only

 Biocompatibility
· During development of AOX Polyethylene, a toxicologist assessed the impact of by-products
created during irradiation. Testing confirmed the levels to be well below the acceptable
toxicology rates to ensure each of these by-products would not have a negative impact
on patients.32
· Zimmer® has not assessed the impact of the by-products created by Vivacit-E® (on a side
note all antioxidant polyethylenes create by-products during sterilization).34

For Salesforce Use Only

REFERENCES:
1. Bourne RB, Chesworth B, Davis A, Mahomed N, Charron K. Comparing
patient outcomes after THA and TKA: is there a difference? Clin Orthop
Relat Res. 2010 Feb;468(2):542-6.
2. Wentorf F, Bandi M, Sauerberg,I, D'Lima DD, Mane AM. Application of
In Vivo Measured Forces Replicates In Vivo Kinematics in a Robotic Sim-
ulator. Poster Number 0255; 59th Annual Meeting of the Orthopaedic
Research Society. 2013 , San Antonio, TX
3. Clary CW, Fitzpatrick CK, Maletsky LP, Rullkoetter PJ. Improving Dy-
namic Mid-stance Stability: An Experimental and Finite Element Study.
Poster Number 1044; 58th Annual Meeting of the Orthopaedic Research
Society. 2012 , San Francisco, CA
4. Qi W, Hosseini A, Rubash HE, Li G. In-vivo Function of the Medial and
Lateral Collateral Ligaments in High Flexion of the Knee. Presentation
001; 80th AAOS Meeting. 2013, Chicago, IL
5. Fitzpatrick CK, Clary CW, Rullkoetter PJ. The Influence of Design on TKR
Mechanics During Activities of Daily Living. Poster No. 2034. 58th An-
nual Meeting of the Orthopaedic Research Society. 2012, San Francisco,
CA.
6. Australian Orthopaedic Association National Joint Replacement Regis-
try. Annual Report. Adelaide, Australia: AOA; 2012. Available at https://
aoanjrr.dmac.adelaide.edu.au/en. Accessed December 5, 2012.
7. Fitzpatrick CK, Clary CW, Rullkoetter PJ. POST-CAM ENGAGEMENT
DURING DYNAMIC ACTIVITY WITH CURRENT POSTERIOR-STABILIZED
TKR. Presentation number 1700. 18th European Society of Biomechan-
ics. 2012. Lisbon, Portugal.
8. Internal DePuySynthes Data taken from DOTS database
9. Zimmer Inc. 11/26/2012. Persona: The Personalized Knee System. Prod-
uct Profiler.
10. Van Citters D, Currier JH, Tibbo ME, Currier BH, Mayor MB. Cross-linked
Polyethylene and Polished Trays: Effective Weapons Against Knee Wear?
Poster Number 165. 79th AAOS Meeeting. 2012, San Francisco, CA.
11. Berry DJ, Currier JH, Mayor MB, Collier JP. Knee wear measured in re-
trievals: a polished tray reduces insert wear. Clin Orthop Relat Res. 2012
Jul;470(7):1860-8.
12. Leisinger S, Hazebrouck S, Deffenbaugh D, Heldreth M. Advanced Fixed
Bearing TKA Locking Mechanism Minimizes Backside Micromotion. 24th
Annual Meeting of the ISTA Congress. 2011 Bruges, Belgium.
13. DePuy Synthes Internal Data.
14. Incavo SJ, Ronchetti PJ, Howe JG, Tranowski JP. Tibial plateau coverage in
total knee arthroplasty. Clin Orthop. 1994;299:81-5.
15. P. Lemaire, D. P. Pioletti, F.-M. Meyer, R. Meuli, J. Dorfl, P.-F. Leyvraz.
Tibial Component Positioning in TKA: Bone Coverage & Extensor Appa-
ratus Alignment. Knee Surg, Sports Traumatol, Arthrosc (1997) 5:251-
257.
16. Wernecke GC, Harris IA, Houang MT, Seeto BG, Chen DB, MacDessi SJ.
Comparison of tibial bone coverage of 6 knee prostheses: a magnetic
resonance imaging study with controlled rotation. J Orthop Surg (Hong
Kong). 2012 Aug;20(2):143-7.
17. Mahfouz M, Scuderi GR, Fatah EA, Bowers LN. Evaluation Of Tibial
Component Coverage In Total Knee Arthroplasty. Presentation 189; 80th
AAOS Meeting. 2013, Chicago, IL
18. Huddleston JI, Scott RD, Wimberley DW. Determination of neutral tibial
rotational alignment in rotating platform TKA. Clin Orthop Relat Res.
2005 Nov;440:101-6.
19. Tsujimoto T, Yamamura K, Ikawa T, Mitsunari K, Kadoya Y. Rotational
Mismatch Between Femoral and Tibial Components after TKA for Varus
Osteoarthritis of the Knee. Presentation 200; 80th AAOS Meeting. 2013,
Chicago, IL
For Salesforce Use Only
20. Amis AA, Senavongse W, Bull AM. Patellofemoral Kinematics During
knee Flexion-Exntesion: An In Vitro Study. J Orthop Res. 2006
Dec;24(12):2201-11.
21. Deacy, JD, Fitzpatrick CK, Laz PJ, Rullkoetter, PJ. Comparison of Natural
and Unresurfaced Patellofemoral Mechanics. Poster number 1062; 54th
Annual Meeting of the Orthopaedic Research Society; 2012; San Francis-
co, CA
22. Clary CW, Komosa MC, Maltesky LP. The Effect of Patellofemoral
Kinematics after Total Knee Replacement. Presentation number 1062.
18th Congress of the European Society of Biomechanics; 2012; Lisbon,
Portugal.
23. Pagnano, MW. Patellar crepitus: A nagging but treatable problem related
to posterior-stabilized TKR. Orthopedics Today. April 22nd, 2009.
24. Oh KJ, Goodman SB, Yang JH. Prospective, randomized study between
Insall-Burstein II and NexGen legacy with a minimum 9-year follow-up. J
Arthroplasty. 2011 Dec;26(8):1232-8.
25. Clary, CW; Wright, AP; Komosa, MC; Maltesky, LP. The Effect of Pa-
tellofemoral Kinematics after Total Knee Replacement. Presentation
number 1262. 18th Congress of the European Society of Biomechanics;
2012; Lisbon, Portugal.
26. Sathasivam & Walker, The Conflicting Requirements of Laxity and Con-
formity in Total Knee Replacement, J. of Biomechanics, 1999, 32, pp.
239-247
27. King R, Arscott E, Narayan V. Biocompatibility Study of Gamma-irradiat-
ed UHMWPE Stabilized with a Hindered-Phenol Antioxidant. ORS Annual
Meeting. 2010a March; Poster #2285.
28. Senyurt AF, Sharp M, Warner D, Narayan VS. Determination of Anti-
oxidant Distribution in Powder and Molded UHMWPE Materials. ORS
Annual Meeting. 2010 March; Poster #2293.
29. King R, Sharp M, Narayan V. Extraction Study of Gamma-Irradiated
UHMWPE Stabilized with a Hindered-Phenol Antioxidant. ORS Annual
Meeting. 2010b March; Poster #2286.
30. Dressler MR, Swope S, Tikka J, Hardaker C, Heldreth M, Render T. Wear
of a Total Knee Replacement with Antioxidant UHMWPE and Gradually
Varying Sagittal Curvature. ORS Annual Meeting. 2012 February: Poster
#0959.
31. Blunn GW, Walker PS, Joshi A, Hardinge K. The Dominance of Cyclic
Sliding in Producing Wear in Total Knee Replacements. CORR. 1991; 273:
253-260.
32. B.L.Armstrong, et. al., J. Pharmaceutical and Biomedical Analysis, 74, pp.
162-70, (2013).
33. Wolf C, Muratoglu OK. Radiation Grafting of Vitamin E to Ultra High
Molecular Weight Polyethylene. ORS Annual Meeting. 2011 February:
Poster #1178.
34. Zimmer Inc. 12/7/12. Vivacit-E® Vitamin E Highly Crosslinked Polyeth-
ylene. Long-term Performance For High Demand Patients. Zimmer
Technical Memo.
35. Michnick SM, Noble PC, Sharma GS, Adams H, Ismaily S, Booth RE,
Mathis KB. The Ergonomics of Efficient Surgical Technique in Total Knee
Replacement. Presentation 421; 80th AAOS Meeting. 2013, Chicago, IL.
36. Clary CW; Fitzpatrick CK; Maletsky LP; Rullkoetter PJ. Probabilistic
Modeling of Femoral Component Overhang. ORS Annual Meeting. 2012
February: Poster #1988.
FOR SALESFORCE USE ONLY

The third party trademarks used herein are trademarks of

their respective owners.

DePuy Orthopaedics, Inc.

700 Orthopaedic Drive
Warsaw, IN 46582
T. +1 (800) 366-8143

www.depuysynthes.com

© DePuy Synthes Joint Reconstruction, a division of DOI 2013. All rights reserved.
SUO-K81 EO 10/13