Integra Cadence Total Ankle System User manual

Cadence®Total Ankle System
EN –ENGLISH ............................................................................................................................................................................. 
CS –ČEŠTINA.............................................................................................................................................................................. 
DA –DANSK................................................................................................................................................................................. 
NL –NEDERLANDS..................................................................................................................................................................... 
FI –SUOMI................................................................................................................................................................................... 
FR –FRANÇAIS............................................................................................................................................................................ 
DE –DEUTSCH............................................................................................................................................................................ 
IT –ITALIANO.............................................................................................................................................................................. 
PT (EU)–PORTUGUÊS............................................................................................................................................................... 
RU  P...........................................................................................................................................................................................62
ES –ESPAÑOL ............................................................................................................................................................................. 
SV –SVENSKA ............................................................................................................................................................................. 

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1
EN – ENGLISH
Cadence®Total Ankle System
Instructions for Use
Caution: U.S. federal law restricts this device to sale by or on
the order of a physician.
Description
The Cadence®Total Ankle System is designed to treat ankle
arthritis through replacement of the ankle joint with a
prosthesis, thereby reducing pain, restoring alignment, and
allowing for movement at the replaced joint.
The prosthesis is composed of a tibial tray, a talar dome and
an insert. Both the tibial tray and talar dome are secured to
patient anatomy; the insert is rigidly fixed to the tibial tray
intra-operatively. When all three components are implanted,
the insert acts as a bearing along the talar dome, enabling
flexion and extension movement at the replaced joint.
Each of the three components is available in a variety of sizes
and design configurations intended for both primary surgery
and revision surgery applications.
Material
The talar dome components are made out of Cobalt Chrome
alloy (CoCr) according to ASTM F1537 and ASTM F75, with a
porous titanium coating (Ti).
The tibial tray components are made out of Titanium alloy
(Ti) Ti-6Al-4V ELI Per ASTM F136, with a porous titanium
coating (Ti).
The insert is made out of highly cross-linked polyethylene
UHMWPE, according to ISO 5834-2 and ASTM F648.
Magnetic Resonance (MR) Statement
The Cadence Total Ankle System has not been evaluated for
safety and compatibility in the MR environment. It has not
been tested for heating, migration, or image artifact in the
MR environment. The safety of Cadence Total Ankle System in
the MR environment is unknown. Scanning a patient who has
this device may result in patient injury.
Indications for Use
The Cadence Total Ankle System is designed to treat ankle
arthritis through replacement of the ankle joint with a
prosthesis, thereby reducing pain, restoring alignment, and
allowing for movement at the replaced joint.
The Cadence Total Ankle System is indicated for use to treat:
• Systemic arthritis of the ankle (e.g. rheumatoid arthritis,
hemochromatosis)
• Primary arthritis (e.g. degenerative disease)
• Secondary arthritis (e.g. post-traumatic, avascular
necrosis, if minimally 2/3 of the talus is preserved)

2
EN – ENGLISH
The Cadence Total Ankle System is also indicated for revision
surgeries following failed total ankle replacement and non-
union/mal-union of ankle arthrodesis, provided sufficient
bone stock is present.
Note: In the United States, this device is intended for
cemented use only.
Note: Outside the United States, this device is intended for
cemented or cementless use.
Contraindications
The Cadence Total Ankle System is contraindicated for:
• Active Infection
• Skeletally immature
• Pregnancy
• Suspected or documented metal allergy or intolerance
• Severe avascular necrosis of the talus/tibia
• Severe malalignment or instability that is not surgically
correctable
• Neurological or musculoskeletal disease that may
adversely affect gait or weight bearing
• Participation in activities that may exert excessive loading
on joint area and prosthesis
• Inadequate neuromuscular status (e.g., prior paralysis,
neuropathy)
• Poor bone stock, poor skin coverage, or excessive bone
loss around the joint which would make the procedure
unjustifiable
• Obesity
• Steroid use
The following conditions present an increased risk of failure:
• Severe osteoporosis; marked bone loss or revision
procedures for which an adequate fit of the prosthesis
cannot be achieved
• Osteomalacia
• Metabolic disorders
• Demonstrates physiological or anatomical anomalies
• Undergoing immunosuppressive therapy
• Malignancy/local bone tumors
• Compromised wound healing
• History of mental illness/instability and non-compliance
• History of drug abuse and/or addiction
Warning: This device is not intended for subtalar joint fusion
or subtalar joint impingement. Please carefully evaluate the
anatomy of each patient before implantation.
Precautions
• Each patient must be evaluated by the surgeon to
determine the specific risk/benefit relationship in light
of the patient’s condition and the surgeon’s practice,
training, experience, and knowledge of the related
medical literature.
• The surgeon should discuss with the patient prior
to surgery possible risks, precautions, warnings,
consequences, complications, and adverse reactions
associated with the surgical procedure and implantation
of the device.
• Patients need to be informed regarding expectations
pertaining to performance and limitations following
surgery. The prosthesis does not replace normal bone,
has a finite service life, and future revision surgeries may
be necessary.

3
EN – ENGLISH
• Excessive loading or trauma may cause premature failure
of the prosthesis.
• Do not attempt a surgical procedure with faulty,
damaged or suspect instruments or implants. Inspect all
components preoperatively to assure utility.
• An adequate inventory of sterile implant sizes should be
on hand at the time of surgery to ensure the optimum size
for the patient.
• Opening of the instruments set must be done according
to aseptic condition.
• When handling the implants, avoid any contact with other
material or tools which may damage the implant surface.
Under no circumstances should the implant be modified.
Damage sustained to the surface of the implant may lead
to implant fracture and/or particulate debris.
• Care must be taken that the correct and appropriate
size implant is used in conjunction with the correct
instrumentation and trial components. Incorrect sizing
may lead to reduced efficacy of the implant.
• When performing total ankle replacement, Cadence Total
Ankle System may not be used in conjunction with other
Integra implant systems unless indicated or with implants
produced by other manufacturers.
• No surgical implants should be reused. Any implant, once
used, should be discarded. Even if it appears undamaged,
it may already have small defects and internal stress
patterns which may lead to implant fracture, fatigue
failure, and/or particulate debris. Reuse of the implant
may cause infection to the patient.
Adverse Effects
Complications with the use of joint prosthesis have been
reported in the medical literature. Any patient undergoing
a surgical procedure is subject to intra-operative and post-
operative complications. Each patient’s tolerance to surgery,
medication, and implantation of a foreign object may be
different.
Possible risks, adverse reactions, and complications
associated with surgery and the use of the prosthesis should
be discussed with and understood by the patient prior to
surgery.
Complications may include but are not limited to:
• Pain, discomfort, or abnormal sensations due to presence
of the implant;
• Bending, loosening, and/or breakage;
• Risk of additional injury from post-operative trauma;
• Migration of the implant position or implant material
resulting in injury;
• Bone loss due to stress shielding
Side effects may include but are not limited to:
• Infections;
• Hematoma;
• Allergy;
• Thrombosis;
• Bone non-union or delayed union
Adverse effects may necessitate re-operation, revision or
removal surgery, arthrodesis of the involved joint, and/or
amputation of the limb. Implant removal should be followed
by adequate post-operative management to avoid fracture
or re-fracture.

4
EN – ENGLISH
MDR Reporting Reminder: Medical device manufacturers and
users are required by law and regulation to report serious
injuries and death.
Post-Operative Care
Preventative actions for the patient to avoid post-operative
complications:
• Avoid extreme motion in flexion-extension
• Wear external immobilization (plaster, splint…) according
to the surgeon’s prescription.
• Receive prompt medical attention for any infection that
could occur, whether at the operated-member level or
elsewhere in the body.
The patient should be encouraged to report to his/her
surgeon any unusual changes of the operated extremity. If
evidence suggests loosening of the implant (particular pain
and progressive changes in the radiographs) an intensified
schedule of check-ups is advised and new warning and
instructions to the patient may be appropriate regarding
further activity restrictions.
Excessive physical activity and trauma affecting the operated
extremity have been implicated in the premature failure of
joint arthroplasty as a result of position change, fracture and/
or wear and tear of the implant.
Sterility
The Cadence Total Ankle System prosthesis components
are supplied sterile. The metal components are sterilized by
gamma radiation, and the polymer (UHMWPE) components
are sterilized by ethylene oxide (EO) gas.
If either the implant or the package appears to be damaged, or
has been opened, or if sterility is questioned for any reason,
the implant should not be used. Re-sterilization of this
product is not recommended.
Inner packaging should be handled under sterile conditions
(persons/instruments).
Do not re-sterilize this product.
Storage
All implants must be stored in a clean, dry environment and be
protected from sunlight and extremes in temperature.
Surgical Procedure
A Surgical Technique brochure is available which outlines
the basic procedure for device implantation and use of the
specialized surgical instrumentation. It is the responsibility
of the surgeon to be familiar with the procedure before
use of these products. Each surgeon must evaluate the
appropriateness of the surgical technique used based on
personal medical training and experience.
Meticulous preparation of the implant site and selection of
the proper size implant increase the potential for successful
reconstruction. A complete set of instruments for each type
of implant is available to aid bone preparation and reduce the
operative time. It is suggested that the proper size implant be
removed from its sterile package only after the implant site
has been prepared and properly sized.
Training
Surgeons may obtain training from a qualified instructor

5
prior to implanting the Cadence Total Ankle System to ensure
thorough understanding of the implantation techniques and
the instrumentation.
PRODUCT INFORMATION DISCLOSURE
INTEGRA HAS EXERCISED REASONABLE CARE IN THE
SELECTION OF MATERIALS AND THE MANUFACTURE OF
THESE PRODUCTS. INTEGRA EXCLUDES ALL WARRANTIES,
WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT
NOT LIMITED TO, ANY IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. INTEGRA SHALL NOT BE LIABLE FOR ANY
INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR
EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM USE
OF THIS PRODUCT. INTEGRA NEITHER ASSUMES NOR
AUTHORIZES ANY PERSON TO ASSUME FOR IT ANY
OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN
CONNECTION WITH THESE PRODUCTS.
Symbol Title of
Symbol Meaning of Symbol Standard Refer-
ence
Number
Sterilized
using
irradiation
Indicates a medical
device that has
been sterilized using
irradiation.
ISO 15223-1
Medical
Devices –
Symbols
to be
used with
medical
device
labels,
labelling
and
information
to be
supplied
5.2.4
Batch code
Indicates the
manufacturer’s batch
code so that the batch
or lot can be
identified.
5.1.5
Catalogue
Number
Indicates the
manufacturer’s
catalogue number so
that the medical
device can be
identified.
5.1.6
Manufacturer
Indicates the medical
device manufacturer,
as defined in EU
Directives 90/385/
EEC, 93/42/EEC and
98/79/EC.
5.1.1
Authorized
representative
in the
European
Community
Indicates the
authorized
representative in the
European Community
5.1.2
Do not use
if package is
damaged
Indicates a medical
device that should not
be used if the package
has been damaged or
opened.
5.2.8

6
Symbol Title of
Symbol Meaning of Symbol Standard Refer-
ence
Number
Use-by date
(YYYY-MM-
DD)
Indicates the date
aer which the
medical device is
not to be used.
ISO 15223-1
Medical
Devices –
Symbols
to be
used with
medical
device
labels,
labelling
and
information
to be
supplied
5.1.4
Consult
instructions
for use
Indicates the
need for the
user to consult
the instructions
for use.
5.4.3
Do not re-use
Indicates a
medical device
that is intended
for one use, or for
use on a single
patient during a
single procedure.
5.4.2
Sterilized
using
ethylene
oxide
Indicates a
medical device
that has been
sterilized using
ethylene oxide.
5.2.3
Quantity
To indicate
the number
of devices per
package.
Proprietary N/A
Symbol Title of
Symbol Meaning of Symbol Standard Refer-
ence
Number
Prescription
Use Only
Caution: Federal
(US) law restricts
this device to sale
by or on the order
of a physician
or licensed
healthcare
practitioner.
Guidance
for Industry:
Alternative
to Certain
Prescription
Device
Labeling
Requirements,
dated January
21, 2000
N/A
Titanium
alloy
To indicate the
material of the
device is titanium
alloy.
N/A N/A
Cobalt
chromium
alloy
To indicate the
material of the
device is cobalt
chromium alloy.
N/A N/A
Ultra high
molecular
weight
polyethylene
To indicate
the material
of the device
is ultra high
molecular weight
polyethylene.
N/A N/A
0086
CE Mark
Product complies
with the
requirements of
directive 93/42/EEC
93/42/EEC N/A

7
CS – ČEŠTINA
Systém pro totální náhradu kotníku Cadence®
Total Ankle System
Návod kpoužití
Upozornění: Federální zákony USA dovolují prodej tohoto
prostředku pouze lékařům nebo na lékařský předpis.
Popis
Systém pro totální náhradu kotníku Cadence® Total Ankle
System je určen kléčbě kotníkové artritidy náhradou
kotníkového kloubu protézou snásledným snížením bolesti,
obnovením zarovnání aumožněním pohybu vyměněného
kloubu.
Protéza sestává ztibiální misky, kopule talu avložky. Tibiální
miska ikopule talu se připevní kanatomickým útvarům
pacienta; vložka se pevně spojí stibiální miskou vprůběhu
operace. Po implantaci všech tří komponent funguje vložka
jako ložisko podél kopule talu umožňující pohyb (flexi
aextenzi) vyměněného kloubu.
Každá ztěchto tří komponent je dostupná vcelé řadě
velikostí akonfigurací designu určených pro primární irevizní
chirurgické zákroky.
Materiál
Komponenty kopule talu jsou vyrobeny ze slitiny kobaltu
achrómu (CoCr) podle ASTMF1537 aASTMF75 sporézním
titanovým (Ti) povlakem.
Komponenty tibiální misky jsou vyrobeny ztitanové (Ti) slitiny
Ti-6Al-4VELI podle ASTMF136 sporézním titanovým (Ti)
povlakem.
Vložka je vyrobena zpolyetylenu svysokou mírou křížových
vazeb UHMWPE podle ISO5834-2 aASTMF648.
Prohlášení pro magnetickou rezonanci (MR)
Systém Cadence Total Ankle nebyl hodnocen zhlediska
bezpečnosti akompatibility vprostředí MR. Systém nebyl
testován zhlediska zahřívání, migrace aobrazových artefaktů
vprostředí MR. Bezpečnost systému Cadence Total Ankle
vprostředí magnetické rezonance není známa. Skenování
pacienta, který má implantován tento prostředek, může vést
kjeho zranění.
Indikace kpoužití
Systém pro totální náhradu kotníku Cadence Total Ankle
System je určen kléčbě kotníkové artritidy náhradou
kotníkového kloubu protézou snásledným snížením bolesti,
obnovením zarovnání aumožněním pohybu vyměněného
kloubu.
Systém Cadence Total Ankle je indikován kpoužití při léčbě:
• Systémové artritidy kotníku (např. revmatoidní artritidy
nebo hemochromatózy).
• Primární artritidy (např. degenerativní onemocnění).
• Sekundární artritidy (např. posttraumatické, avaskulární
nekrózy, pokud je zachováno minimálně 2/3 talu).

8
CS – ČEŠTINA
Systém Cadence Total Ankle je také indikován pro revizní
chirurgické zákroky po selhání totální náhrady kotníku
anesrostlých nebo špatně srostlých artrodéz kotníku, pokud je
přítomno dostatečné množství kostní hmoty.
Poznámka: Ve Spojených státech amerických je zařízení určeno
pouze pro cementované použití.
Poznámka: Mimo Spojené státy americké je zařízení určeno pro
cementované nebo necementované použití.
Kontraindikace
Systém Cadence Total Ankle je kontraindikován vtěchto
případech:
• Aktivní infekce.
• Jedinci snedospělou kostrou.
• Těhotenství.
• Podezření na alergii nebo netoleranci vůči kovům nebo
dokumentovaná alergie či netolerance vůči kovům.
• Vážná avaskulární nekróza talu/tibie.
• Vážné nevyrovnání nebo nestabilita, které nelze napravit
chirurgicky.
• Neurologické nebo kosterně-svalové onemocnění, které
může negativně ovlivnit chůzi nebo nosnost.
• Účast vaktivitách, které mohou způsobit nadměrné
zatížení oblasti kloubu aprotézy.
• Neadekvátní neuromuskulární stav (např. předchozí
paralýza, neuropatie).
• Nedostatek kostní hmoty, nedostatečné zakrytí kůží nebo
nadměrná ztráta kosti kolem kloubu, kvůli které by zákrok
nebyl ospravedlnitelný.
• Obezita.
• Užívání steroidů.
Níže uvedené stavy představují zvýšené riziko selhání:
• Závažná osteoporóza, významná ztráta kostní hmoty nebo
revizní zákroky, ve kterých nelze dosáhnout dostatečného
padnutí protézy.
• Osteomalacie.
• Metabolické poruchy.
• Prokazované fyziologické nebo anatomické anomálie.
• Pacient podstupuje imunosupresivní léčbu.
• Malignita / místní kostní nádory.
• Zhoršené hojení rány.
• Duševní onemocnění/nestabilita anedodržování léčby
vanamnéze.
• Zneužívání drog nebo návykových látek vanamnéze.
Varování: Toto zařízení není určeno pro léčbu fúze subtalárního
kloubu nebo impingement syndromu subtalárního kloubu.
Před implantací pečlivě vyhodnoťte anatomické poměry
pacienta.
Bezpečnostní opatření
• Chirurg musí každého pacienta vyhodnotit aurčit
konkrétní vztah mezi riziky/výhodami ve světle pacientova
stavu asvé praxe, školení, zkušeností aznalostí související
zdravotní literatury.
• Před operací musí chirurg spacientem probrat možná
rizika, upozornění, varování, důsledky, komplikace
anežádoucí reakce spojené schirurgickým zákrokem
aimplantací zařízení.
• Pacienti musí být informováni oočekáváních ve vztahu
kvýkonnosti aomezením po zákroku. Protéza nenahrazuje
normální kost, má omezenou životnost amohou být
nezbytné budoucí revizní zákroky.