Tornier AEQUALIS User Manual

IMP
O
for ha
n
b
efore
requir
e
muscu
l
surgeo
n
scienti
f
about
t
Caut
i
distrib
u
1. De
Aeq
u
The A
e
the se
m
associ
a
which
The gl
e
The h
u
fit wit
h
has th
e
compo
Ancill
a
• t
r
• i
n
For a
m
the tec
h
to imp
l
instru
m
assem
b
anothe
r
recom
m
suppli
e
2. M
a
The co
is mar
k
Ceme
n
are ma
n
availa
b
accord
i
titaniu
m
ultra h
i
Space
r
3. Lo
c
accord
i
manuf
a
chrom
i
Unce
m
manuf
a
availa
b
to AS
T
F-118
5
AST
M
(Ti6Al
molec
u
manuf
a
screws
5832-
7
from t
i
alloy (
C
3. Int
e
The A
e
a func
t
replac
e
•
AEQUA
L
S
H
O
RTANT: The
m
n
dling and impla
n
use. The impla
n
e
s knowledge of
a
l
o-skeletal syste
m
n
must operate i
n
f
ic progress and t
h
t
he device and the
i
on: The Feder
u
tion and use by o
scription:
u
alis Ad
j
ustab
e
qualis Adjustabl
e
m
i-constrained Ae
q
a
tion with Aequal
i
are equivalent.
e
noid implant is c
o
u
meral implant co
n
h
an articular inse
r
e
option of a stem
s
nents are secured
a
ry instruments ar
e
r
ial pieces for test
i
n
struments for the
m
ore detailed desc
h
nical documenta
t
l
ant the Aequalis
A
m
entation specific
a
b
led using Torni
e
r
. The selection
o
m
endations of th
e
e
d with the instru
m
a
terials:
o
nstituent material
k
ed on the packag
i
n
ted Aequalis A
d
nufactured from t
i
b
le in 2 options
i
ng to ASTM F
-
m
alloy (Ti6Al4V
)
i
gh molecular we
i
r
s are manufactur
e
c
king screws ar
e
i
ng to ISO 5832-
7
a
ctured from tit
a
i
um cobalt alloy (
C
m
ented Aequalis
a
ctured from tita
n
b
le in 4 options:
1
T
M F-1185, 3) H
A
5
and ASTM F-1
5
M
F-1580. Metap
h
4V) according to
u
lar weight polyet
h
a
ctured fro
m
tita
n
are manufacture
d
7
. The Securitiz
a
i
tanium alloy (Ti
6
C
oCr) according t
o
e
nded and Indi
e
qualis Adjustabl
e
t
ional deltoid mus
c
e
ment of Shoulder
Rheumatoid
a
INSTRUCTIO
N
L
IS
TM
ADJUS
T
H
OULDER P
IFU-4659
m
anufacturer rec
o
n
ting the devices
n
tation of a joint
a
natomy, biomech
and may be perf
o
n
accordance wi
t
h
e art of surgery.
information cont
a
a
l (United State
s
r on the order of
a
le Reversed
e
Reversed Should
q
ualis Reversed S
h
s Reversed or Ae
q
o
mposed of a bas
e
n
sists of a humera
l
r
t congruent with t
h
s
pacer which exte
n
w
ith a locking scr
e
also provided:
i
ng implantation d
u
assembly and pro
r
iption of the imp
l
t
ion, or contact y
o
A
djustable Rever
s
a
lly designed for
e
r components d
e
o
f the appropriat
e
e
surgical techni
q
m
entation.
of the Aequalis
A
i
ng.
d
justable Revers
e
i
tanium alloy (Ti6
: 1) Uncoated a
n
-
1580. Metaphysi
)
according to IS
O
i
ght polyethylene
e
d from titanium
a
e
manufactured
f
7
. The Securitizat
i
a
nium alloy (Ti6
A
C
oCr) according t
o
Reversed hu
m
n
ium alloy (Ti6A
l
1
) Uncoated, 2)
H
A
P coated over tit
a
5
80 and 4) Titan
h
ysis components
ISO 5832-3. In
s
h
ylene (UHMWP
E
n
ium alloy (Ti6Al
4
d
from chromiu
m
a
tion System Scr
e
6
Al4V) accordin
g
o
ISO 5832-7 res
p
c
ations for use
:
e
Reversed Should
c
le and a massive
a
joints disabled b
y
a
rthritis with pain
N
S FOR USE
T
ABLE REV
E
ROSTHESIS
Rev. C
o
mmends that all
read and under
s
prosthesis and it
anics and reconst
r
o
rmed only by a
q
t
h current inform
The patient must
a
ined in the presen
s
) Law restricts
a
physician.
er humeral impla
n
h
oulder System a
n
q
ualis Reversed II
e
with anchoring s
c
l
stem, a humeral
m
h
e Glenoid spher
e
n
ds the overall le
n
ew and securitiza
t
u
ring the surgery,
per implanting of
l
ants and their util
i
o
ur Tornier repres
e
s
ed shoulder prost
h
this purpose. Tor
n
e
fined as being
e
implants can b
e
q
ue and the trial
A
djustable Reverse
d
e
d humeral imp
l
Al4V) according
t
n
d 2) Titanium
s components ar
e
O
5832-3. Inserts
a
(UHMWPE) acc
o
a
lloy (Ti6Al4V) a
c
f
rom chromium
i
on System Scre
w
A
l4V) according
o
ISO 5832-7 res
p
m
eral implants:
l
4V) according t
o
H
ydroxylapatite (
H
a
nium plasma spr
a
i
um plasma spra
y
are manufacture
d
s
erts are manufac
t
E
) according to IS
O
4
V) according to
m
cobalt alloy (Co
e
w and Locking
C
g
to ISO 5832-3
p
ectively .
:
er System is indic
a
nd non repairabl
e
y
:
E
RSED
personnel respon
s
tand this inform
a
s associated imp
l
r
uctive surgery o
f
q
ualified surgeon.
ation on the stat
e
be properly infor
t instructions for
u
this device to
s
n
t is a component
o
n
d must be used in
glenoid implants,
c
rews and a spher
e
m
etaphysis which
e
. The humeral ste
m
n
gth. The humeral
t
ion screw
the prosthesis.
i
zation, please ref
e
e
ntative. It is esse
n
h
eses with the To
r
n
ier implants mu
s
compatible with
e
made by using
pieces and temp
l
d
Shoulder impla
n
l
ants: Humeral s
t
t
o ISO 5832-3 an
d
plasma spray co
e
manufactured
f
a
re manufactured
f
o
rding to ISO 58
3
c
cording to ISO 5
8
cobalt alloy (C
o
w
and Locking Ca
p
to ISO 5832-3
ectively.
Humeral stems
o
ISO 5832-3 an
d
H
AP) coated accor
d
a
y according to A
S
y
coated accordin
d
from titanium
a
t
ured from ultra
h
O
5834-2. Spacer
s
ISO 5832-3. Loc
k
Cr) according to
C
ap are manufact
u
and chromium c
o
a
ted for patients
w
e
rotator cuff tear
a
s
ible
a
tion
l
ants
f
the
The
e
of
m
ed
u
se.
s
ale,
o
f
e
.
is
m
e
r to
n
tial
r
nier
s
t be
one
the
l
ates
n
ts
t
ems
d
are
ated
f
rom
f
rom
3
4-2.
8
32-
o
Cr)
p
are
and
are
d
are
d
ing
S
TM
g to
a
lloy
h
igh
s
are
k
ing
ISO
u
red
o
balt
w
ith
a
s a
•
•
•
•
•
Notes:
All com
p
The hu
m
•
•
•
•
•
4. Ad
d
The Ae
q
with the
5. Kno
w
Comm
o
Shoul
d
- Poo
- Pre
- Acr
o
- No
n
- Sys
t
- Ra
p
- Ele
v
W
B
- Dis
t
den
t
site
.
imp
- Use
the
u
- Par
a
- Ne
u
- Kn
o
- Pati
- In
s
co
m
6. Side
-
-
-
-
-
-
-
-
-
-
- 7.
W
- Thi
s
of t
h
per
f
- Ne
v
T
HE F
O
REPLAC
- spo
r
- peo
p
- alc
o
- ina
b
phy
• Preo
p
The sur
g
techniq
u
The sur
g
Non-inflamma
t
avascular necr
o
Correction of
f
Fractures of th
e
Traumatic arth
r
Revision of th
e
p
onents are singl
e
m
eral stems:
The uncoated
h
The titanium p
l
cementless us
e
The hydroxyla
p
The hydroxyla
p
cementless us
e
The glenoid i
m
non-cemented
d
itional Notes
q
ualis Adjustable
glenoid compone
n
w
n-contraindi
c
on contraindi
c
d
er:
o
r quality and insu
f
or pe
r
-operative
g
r
omion fracture.
n
functional deltoi
d
t
emic infection, f
e
p
id joint destructio
v
ation of sedime
n
B
C count, or mark
e
t
ant foci of infect
i
t
al focus infectio
n
.
The foci of i
n
p
lantation.
e
of this implant i
s
u
pper brachial pl
e
a
lysis of the axilla
r
u
romuscular disea
s
o
wn allergy to on
e
i
ent pregnancy.
s
ufficient metaph
y
m
ponents impossi
-
effects and po
s
Dissociation o
f
Component lo
o
Dislocation.
Break.
Loss of should
Axillary colu
m
Metal sensitiv
i
rarely reported
Sepsis.
Acromial fract
u
W
arnings and
C
s
product is inten
d
h
is device has not
f
ormance.
v
er re-sterilize an
i
O
LLOWING SITUA
C
EMENT IMPLANT
r
t activity or high
a
p
le likely to fall
o
holism or drug a
b
b
ility of the patien
t
sical therapy prog
p
eratively:
g
eon must be full
y
u
e and know the i
n
g
eon must have ac
t
ory degenerative
j
o
sis)
f
unctional deform
i
e
humeral head
h
ritis
e
devices if suffici
e
use
h
umeral stems are
lasma spray coate
d
e
;
p
atite coated ste
m
p
atite over titaniu
m
e
only
m
plant is anchored
fixation.
Reversed Should
e
nts of the Aequali
c
ations to date:
c
ations for the
f
ficient quantity o
f
g
lenoid fracture.
d
or external rotat
o
e
ver and/or local i
n
o
n or bone resorpti
n
tation rate unex
p
e
d shift in WBC d
i
i
on from genitour
i
n
which may caus
n
fection should b
s
contraindicated
i
e
xus.
a
ry nerve.
s
e (e.g. joint neur
o
e
of the materials.
y
seal bone stock
m
i
ble.
s
sible complica
t
f
glenoid or hume
r
o
sening.
er motion.
m
n erosion.
i
ty in patients foll
o
d
.
u
re caused by fati
g
C
autions:
d
ed for single pati
e
been tested and
m
i
mplant delivered
s
A
TIONS THREATE
N
:
activity level
b
use
t
to follow the sur
g
g
ram.
y
conversant with
a
n
dications and con
c
quainted himself
b
j
oint disease (i.e.
o
i
ty
ent bone stock re
m
for cemented or c
d
stems are for ce
m
m
s are for cementle
m
plasma spray c
o
to the bone with
4
er
humeral stem i
s
s Reversed Shoul
d
Aequalis Adj
u
f
glenoid bone sto
o
r muscles.
n
flammation.
on apparent on ro
e
p
lained by other
d
i
fferential count.
i
nary, pulmonary,
e hematogenous
s
e treated prior t
i
n the presence o
f
o
pathy).
m
aking the stable
t
ions:
r
al components.
o
wing total joint
r
g
ue.
e
nt use only. Re-s
m
ay result in comp
r
s
terile.
N
THE SUCCESS
g
eon's recommen
d
a
ll the aspects of t
h
n
tra-indications of
t
b
efore the operati
o
o
steoarthritis and
m
ains
ementless use;
m
ented o
r
e
ss use only
o
ated stems are fo
r
4
screws and is fo
r
s
used in associat
i
d
er Prosthesis.
u
stable Rever
s
ck.
e
ntgenograms.
d
isease, elevation
skin and other si
t
s
pread to the impl
o, during and a
f
f
significant injur
y
securing of hum
e
r
eplacement has b
e
terilization or reu
s
r
omised device
OF THE SHOUL
D
d
ations and the
h
e surgical
t
his type of impla
n
o
n with the specif
i
r
r
i
on
ed
of
t
es,
a
nt
f
ter
y
to
e
ral
e
en
s
e
ER
n
t.
c

Tornier AEQUALIS Specifications

General

Brand	Tornier
Model	AEQUALIS
Category	Personal Care Products
Language	English

Summary

Instructions for Use Aequalis Adjustable Reversed Shoulder Prosthesis

Description of Aequalis Adjustable Reversed

Details the components of the Aequalis Adjustable Reversed Shoulder humeral implant and associated instruments.

Materials of the Aequalis Adjustable Reversed Shoulder Implants

Specifies the constituent materials used for cemented and uncemented humeral implants.

Intended Use and Indications for Aequalis Adjustable Reversed Shoulder

Outlines the indications for patients with specific shoulder joint disabilities.

Additional Notes on Humeral Stem Use

Clarifies the use of the humeral stem with glenoid components.

Contraindications for the Aequalis Adjustable Reversed Shoulder

Lists common contraindications for using the Aequalis Adjustable Reversed Shoulder system.

Side-Effects and Possible Complications

Details potential adverse effects and complications associated with the implant.

Warnings and Cautions for Shoulder Replacement

Highlights critical warnings and cautions to ensure implant success and patient safety.

Storage, Handling, Packaging, and Sterilization

Storage and Handling Instructions

Provides guidelines for storing and handling implants to preserve their integrity.

Packaging and Sterilization Procedures

Details checks for packaging integrity, expiration dates, and handling during implantation.