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Integra®
Titan™ Total Shoulder System
FRACTURE SURGICAL TECHNIQUE
Table of Contents
Design Rationale........................................................................................................................................................................................................02
Indications/Contraindication/Warnings/Precautions.........................................................................................................................................03
Surgical Technique.................................................................................................................................................................................................... 04
Step 1: Preoperative Templating & Patient Positioning.......................................................................................................................................05
Step 2: Exposure.........................................................................................................................................................................................................05
Step 3: Head Excision and Sizing............................................................................................................................................................................ 06
Step 4: Humeral Canal Preparation........................................................................................................................................................................ 06
Step 5: Distal Trial Stem and Proximal Trial Body Insertion................................................................................................................................ 06
Step 6: Head Trialing and Restoring Humeral Height..........................................................................................................................................07
Step 7: Trial Reduction...............................................................................................................................................................................................07
Step 8: Diaphysis Preparation for Tuberosity Repair..............................................................................................................................................08
Step 9: Prosthesis Assembly and Implantation.................................................................................................................................................... 08
Step 10: Bone Grafting and Tuberosity Repair...................................................................................................................................................... 09
Step 11: Closure.......................................................................................................................................................................................................... 09
Revision Procedure.................................................................................................................................................................................................... 10
Long Stem Option...................................................................................................................................................................................................... 10
Essential Product Information.................................................................................................................................................................................. 11
Instrumentation..........................................................................................................................................................................................................13
Implant Catalog Numbers & Dimensions.............................................................................................................................................................. 19
Design Rationale
Titan Proximal Humerus Fracture Solution
The Titan Total Shoulder System provides a unique way to address what
may be seen as a difficult procedure. Titan’s modular stem design allows
the surgeon to mix component sizes to best fit patient anatomy. The ability
to press-fit the hemiarthroplasty humeral prosthesis to address proximal
humerus fractures gives an advantage of intraoperative height adjustment
without need for jigs or the use of cement.
• Interchangeable proximal bodies and distal stems to accommodate varying
patient anatomy.
• Multiple fixation options (press-fit vs. cemented) to address varying bony
quality.
• Bone impaction humeral preparation technique to preserve bone stock.
• Well-fixed stem provides an intraoperative building platform and a pathway
for revision.
Heads
26 Eccentric & Concentric Humeral Heads in Various Heights
• Optimal osteotomy coverage and soft tissue balancing
Bodies
Textured Modular Bodies in 3 Heights
• Allow for intraoperative height adjustment
• Smaller proximal body size promotes tuberosity consolidation and
increased union opportunity
• Addresses varying patient anatomy
• Promotes initial and long-term bone fixation
Concentric
Head
Eccentric
Head
Body
Screw
Fracture
Body
Cemented
Stem
Press-Fit
Stem
Polished Suture Holes and Groove
• For added bone and soft tissue fixation
• May reduce suture abrasion
Height Lines
• To help simplify replication of trial to definitive prosthesis height
placement
Stems
Press-Fit Stem Option
• No need to remove cement in case of revision
• Bone impaction humeral preparation to preserve bone stock
• 12 splines on stem contribute to enhanced press fit and
anti-rotation for a well fixed stem
Cemented Stem and Cemented Long Stem Options to Address Varying Bone Quality
• Smooth, fluted stem allows for optimal cement fixation
and rotational control
• 5 stem diameters ranging from 6-14 mm to address
varying humeral sizes
• Long Stems in 8, 10 and 12mm diameter options; all available in 125mm and
165mm lengths
• Tapered, polished distal stem for ease of insertion
Titan Total Shoulder System
was developed in collaboration with:
Joseph Abboud, M.D.
Phillip Duke, MB.BS, FRACS, FA(ORTH)A
William Geissler, M.D.
Sanford Kunkel, M.D.
Anand Murthi, M.D.
Matthew Ramsey, M.D.
Mark Ross, MB.BS.FRACS(ORTH)
2
Indications For Use
Total Shoulder Arthroplasty or Hemiarthroplasty is indicated for:
• Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
• Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood
supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory.
• Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed
primary component).
Shoulder Hemiarthroplasty is also indicated for:
• Ununited humeral head fractures.
• Avascular necrosis of the humeral head.
• Rotator cuff arthropathy.
• Deformity and/or limited motion.
The humeral component is intended for cemented or un-cemented use. The glenoid component is intended for cemented use only.
Contraindications
The following conditions are contraindications for total shoulder arthroplasty and hemiarthroplasty:
• Active local or systemic infection.
• Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components.
• Poor bone quality, such as osteoporosis, where there could be considerable migration of the prosthesis and/or a chance of fracture
of the humerus or glenoid.
• Absent, irreparable or nonfunctional rotator cuff or other essential muscles.
• Pregnancy.
• Muscular, neurologic, or vascular deficiencies that compromise the affected extremity.
• Known metal allergies.
Warnings
The use of a glenoid prosthesis in patients with cuff tear arthropathy could increase the risk of glenoid component loosening due
to non-anatomic loading conditions. The following conditions tend to adversely affect shoulder replacement implants;
• Excessive patient weight
• High levels of patient activity
• Likelihood of falls
• Poor bone stock
• Metabolic disorders
• Disabilities of other joints
Precautions
• Do not reuse this device. Reuse of this product may result in infection or other systemic complication that may affect the patient’s
overall health. Additionally, the reuse of this product could adversely affect function of the device. Any implant that has been
damaged, mishandled, or removed from the sterile field may have surface damage that could result in implant fracture and/or
particulate and should be discarded.
• The MR environment presents risks to patients with metal implants. Review of the available literature documents that metal
implants may heat resulting in tissue damage and may migrate out of position. They may also cause artifact affecting image
quality. Physicians should take these risks into consideration when recommending MRI imaging for patients with metal implants.
Note: The Titan Reverse Shoulder System and Titan Total Shoulder System have not been evaluated for safety and compatibility in
the MR environment. Neither the Titan Reverse Shoulder System nor the Titan Total Shoulder System has been tested for heating
or migration in the MR environment.
3
Surgical Technique
As the manufacturer of this device, Integra does not practice medicine and does not recommend this or any
other surgical technique for use on a specific patient. The surgeon who performs any implant procedure is
responsible for determining and using the appropriate techniques for implanting the device in each patient.
Proper surgical procedures and techniques are the responsibility of the medical professional. Individual surgeon evaluation of
the surgical technique should be performed based on his or her personal medical training and experience. This essential product
information does not include all of the information necessary for selection and use of a device. Please see full labeling on package
insert for all necessary information.
The goal of hemiarthroplasty for fracture is to replace the humeral head with a prosthetic component, reconstruct
the rotator cuff, and repair the tuberosities by securing to both the humeral shaft and the prosthesis.
Introduction
A hemiarthroplasty is indicated when salvage of the native humeral head is not possible. This is the case in most head-splitting
fractures of the humeral head, and in impression fractures involving more than 40% of the head. In a typical or “classic” four-part
fracture, the humeral head fragment is separate from the shaft and both tuberosities, and is dislocated out of the glenoid. Figure 1.
The greater and lesser tuberosities are separated from the head fragment, and may be separated from each other. The head is devoid
of all soft-tissue attachment, creating a high probability of avascular necrosis. For this reason, a hemiarthroplasty is typically used in
older patients. In younger patients, especially those with a “valgus impacted” pattern, internal fixation may be preferred.
Description
Displaced 4-Part Fracture Of Proximal Humerus
The pathophysiology of displaced 4-part fractures involves each muscle or muscle group pulling fragments in various directions.
Figure 2.
The diaphysis (1) is drawn medially by the pectoralis major and latissimus dorsi muscles and is separated from the epiphysis at
the surgical neck. The lesser tuberosity (2) is retracted anteromedially by the subscapularis. The greater tuberosity (3) is retracted
medially, superiorly and posteriorly by the supraspinatus, infraspiratus and teres minor. The tuberosities may remain intact or be
fragmented, and may be separated or remain in continuity with one another (impacted type). The humeral articular surface (4) is
no longer in contact with the glenoid. It is separated from the tuberosities and may undergo varus or valgus displacement, usually
resulting in devascularization. It may present an impacted fracture or a displaced fracture.
1
2
3
4
2
1
4
Step 1 • Preoperative Templating and Patient Positioning
3
Preoperative evaluation of the humerus using the modular total shoulder x-ray templates
helps determine the size of the prosthesis and proper height restoration.
Hemiarthroplasty for proximal humerus fracture can be performed using general
anesthesia, regional anesthesia (i.e., interscalene block), or a combination. Place the
patient in beach chair position, Figure 3. This position would have the patient supine
with the hips flexed approximately 30°, knees bent approximately 30° and back elevated
approximately 30°. Specialized headrests, such as the Mayfield or the McConnell, arm
mounts or operating tables with breakaway side panels can facilitate further access to
the top and back of the shoulder.
4
Step 2 • Exposure
A deltopectoral approach is used to provide exposure to the anterior aspect of the
glenohumeral joint, the upper humeral shaft and the humeral head. The initial incision
line runs from the mid-clavicle, over the top of the coracoid and extends in a straight line
down the anterior aspect of the arm, Figure 4. It should follow the path of the cephalic
vein along the interval between the deltoid and the pectoralis major. The length of the
initial incision along this line can vary, depending on the exposure needed to provide
adequate access and visualization of the joint, and is determined by patient body
habitus.
5
Once the initial incision is made, expose, incise and release the fascia. Locate the
cephalic vein at the deltopectoral interval. Separate the deltoid and pectoralis major
muscles so that the deltoid muscle is completely free from its origin to its insertion,
especially along its deep surface. Abduct and externally rotate the arm. Gently retract
laterally the cephalic vein along with the deltoid muscle.
Incise the clavipectoral fascia lateral to expose the conjoined tendon. If needed, release
the upper 25% of the pectoralis major tendon from its insertion on the humerus, using
an electrocautery cutting blade. Figure 5.
Place a Hohmann retractor over the top of the humeral head, pulling the upper part
of the deltoid posteriorly. Check that the rotator cuff tendons are intact. Introduce
self-retaining Weitlander or Kobel retractors underneath the conjoined tendon
and underneath the middle deltoid. It is important to always save or preserve the
coracoacromial ligament.
6
Isolate, clamp and ligate or coagulate the anterior humeral circumflex vessels lying
across the anterior/inferior third of the subscapularis tendon.
In Fracture cases it is important to be aware of the musculocutaneous nerve, which
penetrates the coracobrachialis muscle 3-5 cm distally from the coracoid. The nerve may
not be palpable within the surgical field, but note its proximity to the conjoined tendon.
Figure 6.
Introduce a Hohmann retractor and carefully retract the Axillary nerve along with the
latissimus dorsi tendon. This is especially important as it will protect the axillary nerve,
define and expose the inferior capsule.
Locate the biceps tendon, it can be used to identify the area between the lesser and
greater tuberosity. Using scissors dissect the sheath of the biceps tendon and divide the
transverse humeral ligament. Figure 7.
5
7
Step 2 • Exposure (continued)
8
Release the Biceps tendon from the bicipital groove and along the rotator interval down
to its glenoid attachment. Resect the long head of the biceps at the origin of the superior
glenoid at the transverse humeral ligament.
Step 3 • Head Excision and Sizing
With the tuberosities retracted out of the way via stay sutures or retractors, use a towel
clip or bone hook to remove the humeral head and all fractured pieces. Figure 8.
Measure the removed humeral head on the Head Sizing Gauge, Figure 9. Once size has
been determined harvest any cancellous bone out of the humeral head you may need for
grafting later in the procedure.
9
Step 4 • Humeral Canal Preparation
Attach the 6mm Humeral Stem Trial to the Stem Trial Handle. With the arm in adduction,
external rotation and extension begin sequential trialing starting with the 6mm Humeral
Stem Trial. Follow the path created through the intramedullary canal and increase the
Stem Trial diameter in 1mm increments until the Stem Trial fits securely in the humerus.
Figure 10. Note the final Humeral Stem Trial diameter. This will determine the size of the
Humeral Stem implant. Reduce the tuberosities around the Stem Trial Handle. Using the
laser lines, estimate the body height needed.
Step 5 • Distal Trial Stem and Body Insertion
Attach the selected Stem Trial to the standard size Fracture Body Trial. Attach the Body/
Stem Trial construct to the Fracture Trial Inserter/Extractor.
10
11
Affix the Version Rod to the Fracture Trial Inserter/Extractor to ensure proper version.
The Version Rod is aligned parallel with the patient’s forearm and initially sets the trial in
30° of retroversion. Using the Slotted Mallet, carefully drive the Body/Stem Trial into the
proximal humerus so that the Body/Stem Trial is in line with the long axis. Seat the Body/
Stem Trial until the desired fit is achieved, Figure 11.
6
Step 5 • Distal Trial Stem and Body Insertion (continued)
The Body/Stem Trial should be positioned at the correct height to preserve the anatomic
reconstruction of the tuberosities. If the Fracture Body Trial is too short, the prosthesis
will not allow space for the anatomic reconstruction of the tuberosities. Figure 12. If this
happens remove the Standard Fracture Body Trial and replace with the Large Fracture
Body Trial. This will increase the overall prosthesis height and allow for more surface
area and proper reconstruction of the tuberosities. Figure 13. If the overall prosthesis is
too proud with the Standard Fracture Body Trial, replace it with the Small
Fracture Body Trial.
Placing the prosthesis at the proper level will allow space for anatomic reconstruction of
the tuberosities. If more height is desired after increasing to a Large Fracture Body Trial,
increasing stem diameter will result in a higher seated prosthesis. A slight overlap of the
tuberosities on the prosthesis is desirable.
12
Incorrect
Height
13
Remove the Inserter/Extractor.
STEP 6: Head Trialing and Restoring Humeral Height
Place the Taper Adapter onto the Fracture Body Trial using the Taper Adapter Shaft and
attach the previously selected size Head Trial to the fracture body, Figure 14. This size
was selected after removal and sizing of the humeral head (Table below shows head
options).
WIDTH
HEIGHT
38
14*
40
15*
42
16
44
16, 19
46
14, 17, 20
48
15, 18, 21
50
19, 22
52
20
Correct
Height
14
15
*Only Eccentric Head Option
STEP 7: Trial Reduction
Note the height etchings on the side of the Fracture Body Trial to replicate height of final
implant. Figure 15.
Perform a trial reduction and range of motion test. Ensure that the humeral head remains
in the glenoid fossa and does not ride too high. Also ensure there is free motion with no
undue tightness. Adjust Fracture Body Trial height or Head Trial if there is any height or
soft tissue balance issues. Figure 16.
Reduce the tuberosities to ensure they will fit around the prosthesis and can be attached
to one another. A towel clip or reduction forcep can be utilized to hold the tuberosities
around the prosthesis. Check soft tissue tensioning by performing a gentle range of
motion test.
7
16
Step 8 • Diaphysis Preparation for Tuberosity Repair
17
Drill two suture holes, one on each side of the bicipital groove, into the humeral shaft to
assist in repair of the tuberosities. Place two heavy non-absorbable sutures through the
drill holes before proceeding with prosthesis implantation. Figure 17.
Step 9 • Prosthesis Assembly and Implantation
Body Stem Assembly
Select and remove from their packaging the final sized Fracture Body and Humeral Stem
that corresponds to the trials. Seat and secure the Fracture Body implant onto the Stem
Impaction Stand. Place the Humeral Stem implant onto the Humeral Body with finger
pressure. Place the Stem Impactor over the tip of the humeral stem and engage the
tapers with a few mallet strikes. Figure 18A.
18A
18B
Remove the final Fracture Body/Stem implant construct from the Stem Impaction
Stand and place the implant into the Head Impaction Stand with the appropriate size
Head Impaction Stand Insert. The Head Impaction Stand should match the size of your
Body Trial (SML, STD, LRG) Figure 18B. Tighten the knob on the side of Head Impaction
Stand to secure the implant. Remove the Humeral Body Screw from its packaging and
insert into the Humeral Body with the Driver Handle, Torque Limiter and 1/8 Hex Driver.
Tighten the screw until the torque limiter clicks. Figure 18B.
Cemented Stem
Thoroughly irrigate the medullary canal to remove debris. Use either a small piece of
cancellous bone or utilize a cement restrictor and place 1-2 cm below distal stem to
prevent cement from extruding to the elbow. Use either a medium or high viscosity
cement, place cement down the humeral canal using finger pressure. Figure 19.
Cemented Stem options are available in 2 mm increments (6-14 mm). A definitive
prosthesis sized 1-2 mm smaller than Stem Trial used should be selected to allow for
adequate cement mantle. Attach the final prosthesis to the Fracture Implant Inserter/
Extractor. Affix the Version Rod to the Inserter/Extractor to ensure proper version and
use hand pressure to insert prosthesis. The Version Rod is aligned parallel with the
patient’s forearm and sets the prosthesis in 30° of retroversion. Figure 20. Note the
etchings on the side of the Fracture Body to replicate humeral height from the trial
reduction. Remove any excessive cement from around the fracture body
and suture holes. Allow the cement to dry before proceeding.
Press-fit Stem
Attach the Fracture Implant Inserter/Extractor to the final prosthesis. Attach the Version
Rod to Inserter/Extractor to ensure proper version and use light taps with a mallet to seat
the implant. The Version Rod is aligned parallel with the patient’s forearm and initially
sets the prosthesis in 30° of retroversion. FIGURE 20. Note the etchings on the side of
fracture body; they should replicate humeral height from the trial reduction.
19
20
8
Step 9 • Prosthesis Assembly and Implantation (continued)
21
Humeral Head
Re-trialing of the humeral head is now possible but not required. Once humeral head is
selected, place it on the trunion of the stem. Impact the implant using the Head Impactor
with a few strikes from a mallet, Figure 21.
Step 10 • Bone Grafting and Tuberosity Repair
Impact in the direction
of the trunion axis
Utilizing the bone graft removed earlier from the humeral head, graft the area around the
humeral shaft and Fracture Body. Figure 22.
22
Place two heavy non-absorbable sutures through each of the holes on the medial side
of the prosthesis. Figure 23. Place the arm in neutral position and reduce the greater
tuberosity to its anatomical position.
Take one of the sutures in the superior hole and wrap it around the greater tuberosity
superiorly and secure it down. Figure 24. Repeat using one of the inferior sutures to wrap
around inferiorly and secure the greater tuberosity. Figure 25.
Take the remaining two sutures and place one superiorly and one inferiorly into the
subsacpularis near the insertion into the lesser tuberosity. The opposite ends of the
sutures will wrap around the implant and greater tuberosity which will allow the sutures
to reduce and secure the lesser tuberosity. Figure 26. Use the sutures in the humeral
shaft to tension the tuberosities. Place one suture anteriorly from the subscapularis
to the supraspinatus, and the second suture posteriorly from the supraspinatus to the
infraspinatus, to secure tuberosities to the humeral shaft. Figure 27.
23
The biceps tendon can now be relocated into the bicipital groove and a biceps tenodeses
performed using a modified Kessler stitch into the supraspinatus.
Note
The above tuberosity repair technique is modeled after Dr. Pascal Boileau’s published
cerclage technique.*
24
Step 11 • Closure
Thoroughly irrigate the wound with antibiotic solution. If a regional anesthetic is not
used then infiltrate the soft tissue with a local anesthetic that will last six to eight hours.
A wound drainage system is recommended to prevent formations of postoperative
hematoma.
The wound may be closed according to surgeon preference.
*Boileau P, Walch G, Krishnan S. Tuberosity Osteosynthesis and
Hemiarthroplasty for Four-Part Fractures of the Proximal Humerus.
Techniques in Shoulder and Elbow Surgery 2000; 1(2): 96-109.
9
25
Step 11 • Closure (continued)
26
Careful attention to wound closure will result in a cosmetically acceptable incision.
After the dressing and shoulder immobilizer are in place, the use of a cold wrap is
recommended. The combination of regional anesthetic or local anesthetic and the
immediate cooling seems to decrease the amount of postoperative pain.
Revision Procedure
Removal of the humeral head and/or proximal humeral body during revision surgery can
be achieved without disturbing a well-fixed distal stem.
Removing the Humeral Head
The Humeral Head can be removed using the Head Extractor. Place the two prongs of the
Extractor between the Humeral Head and the osteotomy surface so that the prongs will
advance in each side of the linking component, Figure 28. Lift the head off the proximal
humeral body taper by impacting the end of the Extractor with the Slotted Mallet.
Removing the Proximal Humeral Body
The proximal humeral body can be removed using the Body Separator. Disengage the
locking screw and remove using the 1/8 Hexdriver and Driver Handle. Thread the Body
Separator into proximal humeral body. The pre-designed gap between the tines of the
Body Separator will disengage the morse taper between the Humeral Body and the
Humeral Stem without disruption to a well-fixed Humeral Stem. Remove the Humeral
Body that is threaded to the Body Separator. Figure 29.
27
28
Long Stem Option
The surgical technique for implanting a Titan Long Stem differs slightly from the standard
length stems. Attach the T-Handle to the Starter Awl and create a 6mm pilot hole the
humerus. Continue progressively reaming using cylindrical reamers of increasing diameter
to 8, 10, or 12mm in either the 125mm or 165mm stem length options. The canal is reamed
until cortical chatter is present and inserted to the depth of the laser mark associated
with the desired height of humeral body. It is important to prepare the medullary canal
over its total length. The final reamer used will correlate to the proper trial stem selected.
The reamer, trial, and implant are line to line; minimizing cement to the stem flutes and
within the surrounding trabecular bone. If a greater cement mantle is desired, choose
an long stem implant diameter smaller than the reamer and trial stem diameter used for
preparation.
29
The Body Trials from the Total Shoulder System Humeral Tray 1 Base can be used with the
Trial Cemented Stems to determine proper prosthesis height. The Definitive Stem Primary
Body Trials can be used with the definitive long stem implants once cemented in place to
reassess desired humeral head height.
Notes
The long stems are for cemented use only.
The long reamers are a special order item and do not come with
the standard TSS and RSS instrumentation set.
10
Essential Product Information
Indications For Use
Total Shoulder Arthroplasty or Hemiarthroplasty is
indicated for:
• Severely painful and/or disabled joint resulting from
osteoarthritis, traumatic arthritis or rheumatoid arthritis.
• Fracture-dislocations of the proximal humerus where the
articular surface is severely comminuted, separated from its
blood supply or where the surgeon’s experience indicates
that alternative methods of treatment are unsatisfactory.
• Other difficult clinical problems where shoulder
arthrodesis or resection arthroplasty are not acceptable
(e.g. – revision of a failed primary component).
Shoulder Hemiarthroplasty is also indicated for:
• Ununited humeral head fractures.
• Avascular necrosis of the humeral head.
• Rotator cuff arthropathy.
• Deformity and/or limited motion.
The humeral component is intended for cemented or
un-cemented use. The glenoid component is intended for
cemented use only.
Contraindications
The following conditions are contraindications for total
shoulder arthroplasty and hemiarthroplasty:
• Active local or systemic infection.
• Inadequate bone stock in the proximal humerus or glenoid
fossa for supporting the components.
• Poor bone quality, such as osteoporosis, where there
could be considerable migration of the prosthesis and/or a
chance of fracture of the humerus or glenoid.
• Absent, irreparable or nonfunctional rotator cuff or other
essential muscles.
• Pregnancy.
• Muscular, neurologic, or vascular deficiencies that
compromise the affected extremity.
• Known metal allergies.
11
Warnings
The use of a glenoid prosthesis in patients with cuff tear
arthropathy could increase the risk of glenoid component
loosening due to non-anatomic loading conditions. The
following conditions tend to adversely affect shoulder
replacement implants;
• Excessive patient weight
• High levels of patient activity
• Likelihood of falls
• Poor bone stock
• Metabolic disorders
• Disabilities of other joints
Precautions
• Do not reuse this device. Reuse of this product may result
in infection or other systemic complication that may affect
the patient’s overall health. Additionally, the reuse of this
product could adversely affect function of the device. Any
implant that has been damaged, mishandled, or removed
from the sterile field may have surface damage that could
result in implant fracture and/or particulate and should be
discarded.
• The MR environment presents risks to patients with metal
implants. Review of the available literature documents that
metal implants may heat resulting in tissue damage and
may migrate out of position. They may also cause artifact
affecting image quality. Physicians should take these risks
into consideration when recommending MRI imaging for
patients with metal implants. Note: The Titan Reverse
Shoulder System and Titan Total Shoulder System have
not been evaluated for safety and compatibility in the MR
environment. Neither the Titan Reverse Shoulder System
nor the Titan Total Shoulder System has been tested for
heating or migration in the MR environment.
Sterility
This implant has been sterilized by gamma radiation and
is sterile in the unopened, undamaged package. If either
the implant or the package appears damaged or has been
opened, or if sterility is questioned for any reason, the
implant should not be used. Do not resterilize this product.
Adverse Events
• Potential adverse events include early or late postoperative
infection, allergic reaction, intraoperative or postoperative
bone fracture and/or postoperative pain.
• Intraoperative bone perforation or fracture may occur,
particularly in the presence of poor bone stock caused by
osteoporosis, bone defects from previous surgery, bone
resorption, or while inserting the device.
• Loosening or migration of the implants can occur due to
loss of fixation, trauma, malalignment, bone resorption,
and/or excessive activity.
• Surgical intervention may be required to treat adverse
effects.
• MDR Reporting Reminder: Medical device manufacturers
and users are required by law and regulation to report
serious injuries and death.
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
merchant ability 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.
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
prior to implanting the Titan Total Shoulder System to ensure
thorough understanding of the implantation techniques and
the instrumentation.
12
Instrumentation
CEMENTED LONG STEM BASE
2
3
1
1 Reamers
2 Slap Hammer
3 Adapters
13
Catalog No.
Description
RMR-0950-025-08125
RMR-0950-025-10125
RMR-0950-025-12125
RMR-0950-025-08165
RMR-0950-025-10165
RMR-0950-025-12165
ADA-0950-040-501
ADA-0950-040-502
SLP-1002-519
Reamer Cemented Long Stem, 8mm x 125mm
Reamer Cemented Long Stem, 10mm x 125mm
Reamer Cemented Long Stem, 12mm x 125mm
Reamer Cemented Long Stem, 8mm x 165mm
Reamer Cemented Long Stem, 10mm x 165mm
Reamer Cemented Long Stem, 12mm x 165mm
Trial Adaptor
Stem Adaptor
Slap Adaptor
QTY
1
1
1
1
1
1
1
1
1
CEMENTED LONG STEM INSERT
2
1
This area to remain
empty during sterilization
1 Trial Cemented Long Stems
2 Definitive Stem Primary Body Trials
Catalog No.
Description
TRL-0950-025-08125
TRL-0950-025-10125
TRL-0950-025-12125
TRL-0950-025-18165
TRL-0950-025-10165
TRL-0950-025-12165
TRL-0920-120-08STD
TRL-0920-120-10SML
TRL-0920-120-10STD
TRL-0920-120-10LRG
TRL-0920-120-12STD
TRL-0920-120-14SML
TRL-0920-120-14STD
TRL-0920-120-14LRG
TRL-0950-120-08SML
TRL-0950-120-08STD
TRL-0950-120-08LRG
Trial Cemented Long Stem, 8mm x 125mm
Trial Cemented Long Stem, 10mm x 125mm
Trial Cemented Long Stem, 12mm x 125mm
Trial Cemented Long Stem, 8mm x 165mm
Trial Cemented Long Stem, 10mm x 165mm
Trial Cemented Long Stem, 12mm x 165mm
Definitive Stem Primary Body Trial - 08 Std
Definitive Stem Primary Body Trial - 10 Sml
Definitive Stem Primary Body Trial - 10 Std
Definitive Stem Primary Body Trial - 10 Lrg
Definitive Stem Primary Body Trial - 12 Std
Definitive Stem Primary Body Trial - 14 Sml
Definitive Stem Primary Body Trial - 14 Std
Definitive Stem Primary Body Trial - 14 Lrg
Definitive Stem Primary Body Trial - 08 Sml
Definitive Stem Primary Body Trial - 08 Std
Definitive Stem Primary Body Trial - 08 Lrg
QTY
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
14
Instrumentation
HUMERAL TRAY 1: INSERT
2
1
4
3
5
6
7
8
This area to remain
empty during sterilization
9
15
1
Head Resection Guide
5
Pin Puller
2
Starter Awl
6
Fixation Pins
3
T-Handle
7
Cutting Templates & Handle
4
Version Rods
8
Cutting Depth Gauge
Catalog No.
Description
SET189-A001
AWL-0920-042-001
G108352_B
SET189-D007
3020
PIN-0920-051-001
TMP-0920-040-001R
TMP-0920-040-001L
ROD-0920-040-002
GAU-0920-058-001
HSG-0920-041-001
HSG-0920-041-002
Head Cutting Guide
Starter Awl
T-Handle w/Lg AO
Version Rod
Pin Puller
Fixation Pin
Head Cutting Template, Right
Head Cutting Template, Left
Head Cutting Template, Handle
Head Cutting Depth Gauge
Head Sizing Gauge, 38-46
Head Sizing Gauge, 48-52
QTY
1
1
1
2
1
3
1
1
1
1
1
1
9
Head Sizing Gauge
HUMERAL TRAY 1: BASE
2
1
6
7
9
8
1
Stem Trial Handles
5
Calcar Planers
2
Fracture Trial Inserter/Extractor
6
Taper Adapters
3
Body Trials & Body Screws
7
Cutting Templates & Handle
4
Stem Trials
8
Taper Adapter Handle
Catalog No.
Description
HDL-0920-043-001
INS-0950-046-001 TRL-0920-020-08STD
TRL-0920-020-10SML
TRL-0920-020-10STD
TRL-0920-020-10LRG
TRL-0920-020-12STD
TRL-0920-020-14SML
TRL-0920-020-14STD
TRL-0920-020-14LRG
TRL-0950-020-08SML
TRL-0950-020-08STD
TRL-0950-020-08LRG
BSW-0920-021-01
TRL-0920-025-06
TRL-0920-025-07
TRL-0920-025-08
TRL-0920-025-09
TRL-0920-025-10
TRL-0920-025-11
TRL-0920-025-12
TRL-0920-025-13
Stem Trial Handle
Fracture Trial Inserter/Extractor
Body Trial, 8 Standard
Body Trial, 10 Small
Body Trial, 10 Standard
Body Trial, 10 Large
Body Trial, 12 Standard
Body Trial, 14 Small
Body Trial, 14 Standard
Body Trial, 14 Large
Fracture Body Trial, 8 Small
Fracture Body Trial, 8 Standard
Fracture Body Trial, 8 Large
Body Screws
Humeral Stem Trial, 6mm
Humeral Stem Trial, 7mm
Humeral Stem Trial, 8mm
Humeral Stem Trial, 9mm
Humeral Stem Trial, 10mm
Humeral Stem Trial, 11mm
Humeral Stem Trial, 12mm
Humeral Stem Trial, 13mm
3
4
5
QTY
3
1
1
1
1
1
1
1
1
1
1
1
1
2
1
1
1
1
1
1
1
1
9
Humeral Trial Inserter/Extractor
Catalog No.
Description
TRL-0920-025-14
TRL-0920-025-15
TRL-0920-025-16
INS-0920-046-001
RMR-0920-050-001
RMR-0920-050-002
ADT-0920-065-001
TMP-0920-040-001R
TMP-0920-040-001L
ROD-0920-040-002
SCR-0920-066-001
INS-0950-045-001
Humeral Stem Trial, 14mm
Humeral Stem Trial, 15mm
Humeral Stem Trial, 16mm
Humeral Trial Inserter/Extractor
Calcar Planer, Small
Calcar Planer, Large
Taper Adapter
Head Cutting Template, Right
Head Cutting Template, Left
Head Cutting Template, Handle
Taper Adapter Shaft
Fracture Implant Inserter/Extractor
QTY
1
1
1
1
1
1
4
1
1
1
1
1
16
Instrumentation
HUMERAL TRAY 2: INSERT
4
1
2
3
5
17
1
Ratcheting Screw Driver Handle
2
Eccentric Head Trial Hex Driver
3
Osteotomy Sizing Discs
4
Eccentric Head Trials
Catalog No.
Description
G107992_B
SCR-0920-060-001
HSP-0920-070-001E
HSP-0920-070-002E
HSP-0920-070-003
HSP-0920-070-004
HSP-0920-070-005
HSP-0920-070-006
HSP-0920-070-007
HSP-0920-070-008
TRL-0920-010-3814E
TRL-0920-010-4025E
TRL-0920-010-4216E
TRL-0920-010-4416E
TRL-0920-010-4419E
TRL-0920-010-4614E
TRL-0920-010-4617E
TRL-0920-010-4620E
TRL-0920-010-4815E
TRL-0920-010-4818E
TRL-0920-010-4821E
TRL-0920-010-5019E
Driver Handle w/Sm AO
1/8 Hexdriver
Head Sizing Plate, 38mm
Head Sizing Plate, 40mm
Head Sizing Plate, 42mm
Head Sizing Plate, 44mm
Head Sizing Plate, 46mm
Head Sizing Plate, 48mm
Head Sizing Plate, 50mm
Head Sizing Plate, 52mm
Head Trial, Eccentric, 38x14mm
Head Trial, Eccentric, 40x15 mm
Head Trial, Eccentric, 42x16mm
Head Trial, Eccentric, 44x16mm
Head Trial, Eccentric, 44x19mm
Head Trial, Eccentric, 46x14mm
Head Trial, Eccentric, 46x17mm
Head Trial, Eccentric, 46x20mm
Head Trial, Eccentric, 48x15mm
Head Trial, Eccentric, 48x18mm
Head Trial, Eccentric, 48x21mm
Head Trial, Eccentric, 50x19mm
5
Concentric Head Trials
QTY
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Catalog No.
Description
TRL-0920-010-5022E
TRL-0920-010-5220E
TRL-0920-010-4216C
TRL-0920-010-4416C
TRL-0920-010-4419C
TRL-0920-010-4614C
TRL-0920-010-4617C
TRL-0920-010-4620C
TRL-0920-010-4815C
TRL-0920-010-4818C
TRL-0920-010-4821C
TRL-0920-010-5019C
TRL-0920-010-5022C
TRL-0920-010-5220C
Head Trial, Eccentric, 50x22mm
Head Trial, Eccentric, 52x20mm
Head Trial, Concentric, 42x16mm
Head Trial, Concentric, 44x16mm
Head Trial, Concentric, 44x19mm
Head Trial, Concentric, 46x14mm
Head Trial, Concentric, 46x17mm
Head Trial, Concentric, 46x20mm
Head Trial, Concentric, 48x15mm
Head Trial, Concentric, 48x18mm
Head Trial, Concentric, 48x21mm
Head Trial, Concentric, 50x19mm
Head Trial, Concentric, 50x22mm
Head Trial, Concentric, 52x20mm
QTY
1
1
1
1
1
1
1
1
1
1
1
1
1
1
HUMERAL TRAY 2: BASE
2
1
3
5
4
6
7
8
9
11
10
1
Head Impactor
5
Head Impaction Stand
9
2
Body Screw Hex Driver
6
Body/Stem Separator
10 Body/Stem Impaction Handle
3
Torque Limiter
7
Final Implant Inserter/Extractor
11 Slotted Mallet
4
Head Extractor
8
Head Impaction Stand Adapters
Catalog No.
Description
IMP-0920-079-501
SCR-0920-060-002
G207153
SET188-A001
STD-0920-071-001
SEP-0920-068-001
INS-0920-045-001
INS-0920-071-SML
INS-0920-071-STD
INS-0920-071-LRG
SIS-0920-054-001
IMP-0920-055-001
G107991_B
Head Impactor
3/32 Hexdriver
Torque Limiter
Head Extractor
Head Impaction Stand, Base Assembly
Body Separator
Humeral Implant Inserter/Extractor
Head Impaction Stand Insert, Small
Head Impaction Stand Insert, Standard
Head Impaction Stand Insert, Large
Stem Impaction Stand
Stem Impactor
Slotted Mallet
Body/Stem Impaction Stand
QTY
1
1
1
1
1
1
1
1
1
1
1
1
1
18
Catalog Numbers And Implant Dimensions
Press-Fit Stem Dimensions (mm), Ti
Diameter A
Diameter B
Humeral Head Dimensions (mm), CoCr
Diameter C
Height
Cemented Stem Dimensions (mm), CoCr
Width
A
B
C
Spherical Diameter Ø
Length
PRESS-FIT STEM
CATALOG NO.
LENGTH
DIAMETER
A
DIAMETER
B
DIAMETER
C
SPLINE
DEPTH
NO. OF
SPLINES
HUMERAL HEAD
CATALOG NO.
HEIGHT WIDTH
SPHERICAL
DIAMETER Ø
OFFSET
(ECCENTRIC)CONCENTRIC
STEM-0920-025-06
90.4 11.6 6.8 4.61 12
MHH-0920-010-3814X
14
38
41
2.5
No Option
STEM-0920-025-07
90.412.4 7.6 5.3 1 12
MHH-0920-010-4015X
15
40
43
2.5
No Option
STEM-0920-025-08
90.413.7 9.0 6.61 12
MHH-0920-010-4216X
1642 45
4
C
STEM-0920-025-09
90.414.4 9.9 7.41 12
MHH-0920-010-4416X
1644 48
4
C
STEM-0920-025-10
90.415.410.9 8.51 12
MHH-0920-010-4419X
1944 45
4
C
STEM-0920-025-11
90.416.5 12.1 9.51 12
MHH-0920-010-4614X
1446 54
4
C
STEM-0920-025-12
90.4 17.5 13.210.61 12
MHH-0920-010-4617X
1746 49
4
C
STEM-0920-025-13
90.418.5 14.2 11.61 12
MHH-0920-010-4620X
2046
4
C
47
STEM-0920-025-14
90.419.5 15.3 12.61 12
MHH-0920-010-4815X
1548 56
4
C
STEM-0920-025-15
90.420.5 16.4 13.5 1 12
MHH-0920-010-4818X
1848 51
4
C
STEM-0920-025-16
90.421.5 17.4 14.7 1 12
CEMENTED STEM
CATALOG NO.
LENGTH
DIAMETER
A
DIAMETER
B
DIAMETER
C
NO. OF
FLUTES
STEM-0950-025-06
90.4 9.6 6.1 4.64
STEM-0950-025-08
90.411.6 8.1 6.74
STEM-0950-025-10
90.413.4 9.9 8.54
STEM-0950-025-12
90.415.4 11.9 10.64
STEM-0950-025-14
90.4 17.5 14.0 12.64
CEMENTED LONG
STEM CATALOG NO.
LENGTH
DIAMETER
A
DIAMETER
B
DIAMETER
C
NO. OF
FLUTES
MHH-0920-010-4821X
2148 49
4
C
MHH-0920-010-5019X
1950 53
4
C
MHH-0920-010-5022X
2250
51
4
C
MHH-0920-010-5220X
2052
55
4
C
Fracture Body Dimensions (mm), Ti
Trunnion
Offset
Max Length
STEM-0950-025-08125 125 11.5 8.0 6.04
Height
STEM-0950-025-08165 165 11.5 8.0 6.04
STEM-0950-025-10125
125
13.5
10.0
8.0
4
STEM-0950-025-10165 165 13.5 10.0 8.04
STEM-0950-025-12125 125 15.5 12.0 10.04
Max Width
STEM-0950-025-12165 165 15.5 12.0 10.04
Base Diameter
FRACTURE BODY
CATALOG NUMBER
HEIGHT
MAX
LENGTH
MAX
WIDTH
BASE
DIAMETER
TRUNNION
OFFSET
BOD-0950-020-08SML 30 16.711.611.6 8
BOD-0950-020-08STD 35 16.911.611.6 8
BOD-0950-020-08LRG 40 17.111.611.6 8
BSW-0920-021-01
19
Body Screw
20
Integra®
Titan Total Shoulder System
™
For more information or to place an order, please contact:
United States, Canada, Asia, Pacific, Latin America
USA 877-444-1122 866-800-7742 fax
Outside USA 609-936-5400 609-750-4259 fax
integralife.com
0086
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Europe, Middle-East, Africa
International: +33 (0)4 37 47 59 50 +33 (0)4 37 47 59 25 fax
Benelux: +32 (0)2 257 4130 +32 (0)2 253 2466 fax
France: +33 (0)4 37 47 59 10 +33 (0)4 37 47 59 29 fax
Switzerland: +41 (0)22 721 23 00 +41 (0)22 721 23 99 fax
United Kingdom: +44 (0)1 264 345 781 +44 (0)1 264 363 782 fax
integralife.eu
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EC REP
Ascension Orthopedics, Ltd.
BioPark
Broadwater Road
Welwyn Garden City
Herts. AL7 3AX
United Kingdom
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Manufacturer:
Ascension Orthopedics, Inc.
8700 Cameron Road
Austin, Texas 78754
Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.
Always refer to the appropriate instructions for use for complete clinical instructions.
Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.
Warning: Applicable laws restrict these products to sale by or on the order of a physician.
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Additional information for EMEA Customers only:
Products mentioned in this document are CE class I, IIa, IIb or III devices. Contact Integra should you need any additional information on devices classification. All the medical devices
mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.
Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.
Titan is a trademark of Integra LifeSciences Corporation or its subsidiaries. ©2014 Integra LifeSciences Corporation. All rights reserved. Printed in USA. 0278440-1-EN LC-0927-002 Rev C