Tornier AEQUALIS Instructions For Use

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