IMPO
for han
before
require
muscul
surgeon
scientif
about t
Cauti
distribu
1. De
Aequ
The Ae
the sem
associa
which
The gle
The hu
fit with
has the
compo
Ancilla
•
tr
•
in
For a m
the tech
to impl
instrum
assemb
another
recomm
supplie
2. Ma
The co
is mark
Cemen
are man
availab
accordi
titanium
ultra hi
Spacer
3. Loc
accordi
manufa
chromi
Uncem
manufa
availab
to AST
F-1185
ASTM
(Ti6Al
molecu
manufa
screws
5832-7
from ti
alloy (C
3. Inte
The Ae
a funct
replace
•
AEQUAL
SH
ORTANT
:
The m
ndling and implan
use. The implan
es knowledge of a
lo-skeletal system
n must operate in
fic progress and th
the device and the
ion
:
The Feder
ution and use by o
scription:
ualis Adjustab
equalis Adjustable
mi-constrained Aeq
ation with Aequali
are equivalent.
enoid implant is co
umeral implant con
h an articular inser
e option of a stem s
nents are secured
ary instruments are
rial pieces for testi
nstruments for the
more detailed desc
hnical documentat
lant the Aequalis A
mentation specifica
bled using Tornie
r. The selection o
mendations of the
ed with the instrum
aterials:
onstituent material
ked on the packagi
nted Aequalis Ad
nufactured from ti
ble in 2 options
ing to ASTM F-
m alloy (Ti6Al4V)
igh molecular wei
rs are manufacture
cking screws are
ing to ISO 5832-7
actured from tita
ium cobalt alloy (C
mented Aequalis
actured from titan
ble in 4 options: 1
TM F-1185, 3) HA
5 and ASTM F-15
M F-1580. Metaph
4V) according to
ular weight polyeth
actured from titan
are manufactured
7. The Securitiza
itanium alloy (Ti6
CoCr) according to
ended and Indi
equalis Adjustable
tional deltoid musc
ement of Shoulder
Rheumatoid a
INSTRUCTION
LIS
TM
ADJUST
HOULDER P
IFU-4659
manufacturer reco
nting the devices
ntation of a joint
anatomy, biomech
and may be perfo
n accordance wit
he art of surgery.
information conta
al (United States
r on the order of a
le Reversed
e Reversed Should
qualis Reversed Sh
s Reversed or Aeq
omposed of a base
nsists of a humeral
rt congruent with th
spacer which exten
with a locking scr
e also provided:
ing implantation du
assembly and pro
ription of the impl
tion, or contact yo
Adjustable Revers
ally designed for
er components de
of the appropriate
e surgical techniq
mentation.
of the Aequalis A
ing.
djustable Reverse
itanium alloy (Ti6
: 1) Uncoated an
-1580. Metaphysi
) according to ISO
ight polyethylene
ed from titanium a
e manufactured f
7. The Securitizati
anium alloy (Ti6A
CoCr) according to
Reversed hum
nium alloy (Ti6Al
1) Uncoated, 2) H
AP coated over tita
580 and 4) Titan
hysis components
ISO 5832-3. Ins
hylene (UHMWPE
nium alloy (Ti6Al4
d from chromium
ation System Scre
6Al4V) according
o ISO 5832-7 resp
cations for use:
e Reversed Should
cle and a massive a
joints disabled by
arthritis with pain
NS FOR USE
TABLE REVE
ROSTHESIS
Rev. C
ommends that all
read and unders
prosthesis and it
anics and reconstr
ormed only by a q
th current inform
The patient must
ained in the presen
s) Law restricts
a physician.
er humeral implan
houlder System an
qualis Reversed II
e with anchoring sc
l stem, a humeral m
he Glenoid sphere
nds the overall len
ew and securitizat
uring the surgery,
per implanting of
lants and their utili
our Tornier represe
sed shoulder prosth
this purpose. Torn
efined as being
e implants can be
que and the trial
Adjustable Reversed
ed humeral impl
Al4V) according t
nd 2) Titanium
s components are
O 5832-3. Inserts a
(UHMWPE) acco
alloy (Ti6Al4V) ac
from chromium
ion System Screw
Al4V) according
o ISO 5832-7 resp
meral implants:
l4V) according to
Hydroxylapatite (H
anium plasma spra
ium plasma spray
are manufactured
serts are manufact
E) according to ISO
4V) according to
m cobalt alloy (Co
ew and Locking C
g to ISO
5832-3
pectively
.
:
er System is indic
and non repairable
y:
ERSED
personnel respons
tand this informa
s associated impl
ructive surgery of
qualified surgeon.
ation on the state
be properly infor
t instructions for u
this device to s
nt is a component o
nd must be used in
glenoid implants,
crews and a sphere
metaphysis which
e. The humeral stem
ngth. The humeral
tion screw
the prosthesis.
ization, please refe
entative. It is essen
heses with the Tor
nier implants mus
compatible with
e made by using
pieces and templ
d Shoulder implan
lants:
Humeral st
to ISO 5832-3 and
plasma spray co
e manufactured f
are manufactured f
ording to ISO 583
ccording to ISO 58
cobalt alloy (Co
w and Locking Cap
to ISO 5832-3
ectively.
Humeral stems
o ISO 5832-3 and
HAP) coated accord
ay according to AS
y coated accordin
d from titanium a
tured from ultra h
O 5834-2. Spacers
ISO 5832-3. Lock
Cr) according to
Cap are manufactu
and chromium co
ated for patients w
e rotator cuff tear a
sible
ation
lants
f the
The
e of
med
use.
sale,
of
e.
is
m
er to
ntial
rnier
st be
one
the
lates
nts
tems
d are
ated
from
from
34-2.
832-
oCr)
p are
and
are
d are
ding
STM
g to
alloy
high
s are
king
ISO
ured
obalt
with
as a
•
•
•
•
•
Notes:
All comp
The hum
•
•
•
•
•
4. Add
The Aeq
with the
5. Know
Commo
Should
-
Poo
-
Pre
-
Acro
-
Non
-
Syst
-
Rap
-
Elev
WB
-
Dist
dent
site.
imp
-
Use
the u
-
Para
-
Neu
-
Kno
-
Pati
-
Ins
com
6. Side-
-
-
-
-
-
-
-
-
-
-
7.
W
-
This
of th
perf
-
Nev
T
HE FO
REPLAC
-
spor
-
peop
-
alco
-
inab
phy
•
Preop
The surg
techniqu
The surg
Non-inflammat
avascular necro
Correction of f
Fractures of the
Traumatic arthr
Revision of the
ponents are single
meral stems:
The uncoated h
The titanium pl
cementless use
The hydroxylap
The hydroxylap
cementless use
The glenoid im
non-cemented
ditional Notes
qualis Adjustable
glenoid componen
wn-contraindic
on contraindic
der:
or quality and insuf
or per-operative g
romion fracture.
n functional deltoid
temic infection, fe
pid joint destructio
vation of sedimen
BC count, or marke
tant foci of infecti
tal focus infection
. The foci of in
plantation.
e of this implant is
upper brachial ple
alysis of the axillar
uromuscular diseas
own allergy to one
ient pregnancy.
sufficient metaphy
mponents impossi
-effects and pos
Dissociation of
Component loo
Dislocation.
Break.
Loss of should
Axillary colum
Metal sensitivi
rarely reported
Sepsis.
Acromial fractu
Warnings and C
s product is intend
his device has not
formance.
ver re-sterilize an i
OLLOWING SITUA
CEMENT IMPLANT
rt activity or high a
ple likely to fall
oholism or drug ab
bility of the patient
sical therapy prog
peratively:
geon must be fully
ue and know the in
geon must have ac
tory degenerative j
osis)
functional deformi
e humeral head
hritis
e devices if suffici
e use
humeral stems are
lasma spray coated
e;
patite coated stem
patite over titanium
e only
mplant is anchored
fixation.
Reversed
Shoulde
nts of the Aequali
cations to date:
cations for the
fficient quantity of
glenoid fracture.
d or external rotato
ever and/or local in
on or bone resorpti
ntation rate unexp
ed shift in WBC di
ion from genitouri
n which may caus
nfection should b
s contraindicated i
exus.
ary nerve.
se (e.g. joint neuro
e of the materials.
yseal bone stock m
ible.
ssible complicat
f glenoid or humer
osening.
er motion.
mn erosion.
ity in patients follo
d.
ure caused by fatig
Cautions
:
ded for single patie
been tested and m
implant delivered s
ATIONS THREATEN
:
activity level
buse
t to follow the surg
gram.
y conversant with a
ndications and con
cquainted himself b
joint disease (i.e. o
ity
ent bone stock rem
for cemented or c
d stems are for cem
ms are for cementle
m plasma spray co
to the bone with 4
er
humeral stem is
s Reversed Should
Aequalis Adju
f glenoid bone sto
or muscles.
nflammation.
on apparent on roe
plained by other d
ifferential count.
inary, pulmonary,
e hematogenous s
e treated prior t
in the presence of
opathy).
making the stable
tions:
ral components.
owing total joint r
gue.
ent use only. Re-s
may result in compr
sterile.
N THE SUCCESS
geon's recommend
all the aspects of th
ntra-indications of t
before the operatio
osteoarthritis and
mains
ementless use;
mented or
ess use only
oated stems are for
4 screws and is for
s used in associati
der Prosthesis.
ustable Revers
ck.
entgenograms.
disease, elevation
skin and other sit
spread to the impl
o, during and af
f significant injury
securing of hume
replacement has be
terilization or reus
romised device
OF THE SHOULD
dations and the
he surgical
this type of implan
on with the specifi
r
r
ion
ed
of
tes,
ant
fter
y to
eral
een
se
ER
nt.
c
