Epoca Shoulder Arthroplasty System – Fracture. Hemi and ...

Epoca Shoulder Arthroplasty System – Fracture. Hemi and total joint replacement for fractures.

Surgical Technique

This publication is not intended for distribution in the USA.

Instruments and implants approved by the AO Foundation.

Discontinued – December 2018

103408-181130

Epoca Shoulder Arthroplasty System – Fracture Surgical Technique DePuy Synthes 1

Introduction

Surgical Technique

Care and Maintenance

Product Information

Bibliography

MRI Information 60

Epoca Shoulder Arthroplasty System 2

AO Principles 4

Indications and Contraindications 5

Clinical Cases 6

Preoperative Planning 8

Patient Positioning 9

Hemiarthroplasty for Fractures 10

Implantation of a Glenoid Component 29

43

Implants 44

Special Implants 48

Instruments 49

59

Table of Contents

Image intensifier control

WarningThis description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.

Processing, Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

2 DePuy Synthes Epoca Shoulder Arthroplasty System – Fracture Surgical Technique

Epoca Shoulder Arthroplasty System.Anatomic reconstruction of the proximal humerus.

The Epoca resurfacing head is intended for minimally invasive treatment of early stage arthritis or other arthropathies with cartilage damage. – Thin surface allows for minimum

bone removal – Anatomic reconstruction of

articulat ing surface – Stable and bone sparing crown

fixation – TiNb coated version for nickel

sensitive patients

Head

– Height proportional to radius – Anatomic design – Can be adjusted for medial

and posterior fit – TiNb coated version for nickel

sensitive patients

Stem

The Epoca Shoulder Arthroplasty sys-tem aims to restore glenohumeral kine-matics in fractures and degenerative cases. The Epoca implant facilitates anatomic reconstruction of the proxi-mal humerus. – Anatomic design mimics contour of

the medial calcar and medullary canal

– Non-protruding lateral design reduces risk of damage to the inser-tion facet of the supraspinatus tendon

– Medial and lateral holes in the stem allow for stable reattachment of the tuberosities

– Available in a variety of diameters and lengths, L and XL stems for revision

– Titanium for nickel sensitive patients

RH Resurfacing Head Stem for Fractures and Degenerative Conditions


Eccenter Disc

– Allows medial and posterior offset adjustments

– Independent adjustment of the head vs. shaft

– Press-fit assembly outside the patient

The Epoca shoulder prosthesis is intended for use as a hemi- or total shoulder replacement – Ensures congruent glenohumeral

implant surfaces to achieve normal range of motion

– Reduced size and beveled rim for normal mobility and reduced risk of impingement

– Hybrid application with shell screws – Cementless application with metal-

back glenoid

The Epoca Reco glenoid reconstruction device is intended to reestablish a stable fulcrum in order to prevent antero superior subluxation of the humeral head.

Glenoid Reco Glenoid


Anatomic reduction – Anatomical implant-design preserves anatomical and

kinematic principles – Minimal resection preserves anatomical structures

Stable fixation – Implant design based on anatomical study leads to good

implant-bone-fixation – Stable osteosynthesis of the tuberosities in stable conjunc-

tion with stem-implant

Preservation of blood-supply – Anatomical reduction and osteosynthesis of the tuberosi-

ties in trauma case – Minimal resection preserves anatomical structures and

blood supply

Early mobilization – Anatomical design with maximum bone-preservation

allow early mobilzation – Combination of stable osteosynthesis and anatomical

implant allow early mobilization

AO Principles


Indications – Irreparable fractures of the proximal humerus – Posttraumatic conditions with advanced joint destruction – Failed previous osteosynthesis

A glenoid component may be indicated in cases of cartilage destruction or in case of an associated irreparable glenoid fracture where gleno-humeral stability is a concern. Contraindications – Infections, acute or chronic, local or systemic – Severe muscular, neurological or vascular deficiencies,

which compromise the affected extremity – Destruction of bone or poor bone quality, which may

affect stability of the implant – Any concomitant disease which may compromise the

function of the implant – Any other pathology which needs treatment priority

Conditions which can adversely affect joint replacement success – Severe osteoporosis – Severe deformities, congenital dislocation – Allergic reaction to any of the materials used – Local tumors of the bone – Systemic and metabolic disorders – History of infectious disease – History of falls – Drug or alcohol addiction and / or abuse – Obesity – High level of physical activity, involving shocks and

shaking in which the prosthesis is subject to pounding and / or excessive strains (e.g.: heavy physical labor, repetitive stress from sports, etc.)

Indications and Contraindications


Female patient, 65 years oldComminuted 4-part fracture with ischemic head, right shoulder

Clinical Case 1

AP view

Preoperative

Axillary view

Postoperative

AP view Axillary view


Female patient, 65 years oldComminuted 4-part fracture with ischemic head and osteoporosis, left shoulder

Clinical Case 2

AP view

AP view

Preoperative

Postoperative


Complete the preoperative radiographic assessment withstandard AP, lateral and axillary views. A CT scan is required when the axillary view is not optimal, i.e. when more infor-mation about the lesser tuberosity is required.

An AP view of the contralateral humerus is optional. It is helpful to estimate the size of the prosthetic head and stem.

Place the template on the AP view of the contralateral humerus to estimate the head and stem size. Then, draw the outer contour of the proximal humerus and the implant on transparent paper or on an electronic support using a com-puter assisted planning tool.

Flip the image horizontally and superimpose it on the patho-logical side. Determine the required corrections.

Preoperative planning for glenoid replacementGlenoid replacement may be indicated in cases of anterior fracture dislocations which are associated with significant glenoid fractures, such as Ideberg type II fractures. When planning a glenoid replacement procedure, axial CT scan views are recommended in order to assess the amount of glenoid damage and the correction needed.

Additionally, a CT-based three-dimensional reconstruction of the glenoid (with the removal of the humeral head from the 3-D model) could help estimate the shape and size of glenoid defects.

Preoperative Planning


Position the patient in a beach-chair position.

Avoid hyperextension and lateral inclination of the cervical spine in order to prevent tension on the brachial plexus.

Ensure that the patient’s arm is freely extendable.

Ensure that a C-arm can be placed so that adequate images can be obtained when needed.

Patient Positioning


1Approach 1

Standard deltopectoral approachStart the incision over the acromioclavicular joint and extend it 8 cm inferior over the anterior deltoid, lateral to the del-topectoral groove. Alternatively, follow Langer’s skin tension lines starting from the acromioclavicular joint.

Open the fascia over the deltopectoral groove and identify the cephalic vein. Retract the deltoid with the cephalic vein laterally, and the pectoralis major medially.

Incise the clavipectoral fascia.

Hemiarthroplasty for Fractures

2Expose fracture

Irrigate and remove the hematoma to expose the fracture. Check the vascularity of the humeral head and confirm that joint replacement is the optimal form of care.

Pass stay sutures through the infraspinatus tendon to aid manipulation of the greater tuberosity fragment.

Expose and transect the biceps tendon in its extraarticular path. Suture the biceps tendon to the pectoralis major fascia.

Locate the split in the supraspinatus tendon induced by the fracture. Enlarge the split in the supraspinatus tendon, as required, for access to the joint.

Retrieve the fractured humeral head and set it aside for later use. Examine the glenoid. Consider ORIF or glenoid replace-ment if there is a relevant fracture of the glenoid or glenoid rim.

1 see Hertel et al., 331–338.


3Prepare tuberosities for later fixation

Implant

02.401.000S Wire-Cable B 1.0 mm, with Crimp

Pass stay-sutures through the subscapularis, supraspinatus, and infraspinatus tendons.

Drill two holes in the greater tuberosity with a 2.0 mm drill bit. The two holes should be approximately aligned with the medial and lateral perforations of the prosthetic stem. Drill the holes close to the point of transition from tendon to bone.

Using the wire portion of the wire-cable, pass the 1.0 mm wire-cables through the drill holes. Alternatively, cerclage wires or high strength sutures can be used. Park the wire- cables posteriorly, so that they do not interfere with the remaining steps of the procedure.

Note: The wire portion of the wire-cable can be shortened to the desired length.

Expose the shaft by extending, adducting, and externally rotating the humerus.

X


5Select trial head

Instruments

E5114-40– Trial Heads, sizes 40 to 54E5114-54

Osteotomize any remaining metaphyseal extensions to better visualize the head. Compare the retrieved humeral head with the available trial heads. Choose the trial head that closely matches the retrieved head. Save the humeral head for later use as bone graft.

Note: If the AP and lateral radii differ, choose an intermedi-ate trial head size.


4Determine stem height

Instrument

03.401.083 Ruler, length 250 mm, Stainless Steel

Measure the medial metaphyseal extension on the retrieved head. This distance determines the precise height of the stem, i.e: how much the stem must protrude in respect to the medial fracture line. Note the height for later reference.


6Open medullary canal and determine retrotorsion

Instruments

359.221 Combined Hammer

E5115-1 Retrotorsion Bar B 6.0 mm

E5115-2 Goniometer

E5112-6– Rasps, sizes 6 to 14 E5112-14

03.401.084 Curette, oval, with Toothing, length 300 mm

Probe and clean the medullary cavity with a sharp curette. Insert the size 6 rasp into the canal.

To check the rotational alignment, insert the 6.0 mm retro-torsion bar into the threaded hole of the rasp. Hold the gonio meter onto the lateral side of the retrotorsion bar. For the first rough adjustment, align the rasp to 25° retrotorsion with reference to the axis of the forearm. This measurement reflects the median retrotorsion value for a normal popula-tion.1

1 see Hertel et al., 331–338.

8mm


Hammer in the rasp until proper seating is obtained. If the rasp penetrates too deep into the medullary cavity, use the next larger rasp size until the correct prosthetic height is ob-tained. Should you have difficulties fully inserting the chosen rasp, remove additional bone along the medial endosteal region using a sharp curette. This will allow the rasp to seat and self-lock a few millimeters deeper.

The pronounced calcar design provides the rasp and the implants with self-centering, self-rotating and self-locking capabilities.

Confirm the retrotorsion by cross-checking against the bicipi-tal groove. The distance between the deepest point in thebicipital groove and the center line of the rasp should beapproximately 8 mm.2


2 see Hempfing et al., 460–463.


7Insert trial stem

Instruments


E5113-6 – Trial Stems, sizes 6 to 14E5113-14

E5115-2 Goniometer

E5115-3 Slotted Hammer/Extractor


Attach the inserter/extractor to the selected trial stem. Apply controlled light blows to the top of the inserter / extractor with the hammer. Hammer until the trial stem protrudes above the shaft, as determined in step 4.

To confirm the retrotorsion of the trial stem, insert the 3.0 mm retrotorsion bar into the hole of the trial stem.

Use the goniometer to measure the retrotorsion.


8Attach trial eccenter disc

Instruments

E5115-4 / 2 Screwdriver Epoca, width across 2.0 mm, for Trial Implants

E5117-20 Trial Eccenter Disc

Attach the trial eccenter disc to the trial stem.

Align the letter ‘A’ on the trial eccenter disc with the lateral line on the trial stem. This position reflects the normal (median) offset.

Lock the trial eccenter disc using a 2.0 mm hex screwdriver in the proximal hole.



9Insert trial head

Instruments

E5114-40 – Trial Heads, sizes 40 to 54E5114-54




Use a 2.0 mm hex screwdriver to back out the set screws from the trial head in order to allow for correct seating. Be careful not to back out the set screws too far, as they may fall out.

Mount the trial head on the trial eccenter disc. Align the ap-propriate marking on the trial head with the center line on the trial stem (‘L’ for left humerus, ‘R’ for right humerus).

Lock the trial head in position by tightening the anterior set screw. Verify that the offset is appropriate for the patient’s anatomy. The ideal position is reached when the head meets the medial calcar line with a continuous or unbroken line, i.e.: no overhang or medial step-off.

If the offset is not appropriate, adjust the anteroposterior position and / or the mediolateral offset. Loosen the trial eccenter disc with the 2.0 mm hex screwdriver. Use the 2.5 mm hex screwdriver to rotate the trial eccenter disc until the desired head position is achieved.

Note: Should the screw in the trial head be missing, a screw from another trial head may be used instead.


For further adjustment, loosen the anterior set screw on the trial head with the 2.0 mm hex screwdriver and manually rotate the trial head until the desired position is obtained. Lock the position by tightening the set screw.

Note: The 2.0 mm hex screwdriver is used for locking and unlocking the set screws, the 2.5 mm hex screwdriver is used only to rotate the eccenter disc.

Record the offset position of the trial head.



10Remove trial implants

Instruments


E5115-3 Slotted Hammer/Extractor



Once the offset position of the trial head is recorded, remove the trial head using the 2.0 mm hex screwdriver.

Record the offset position of the trial eccenter disc.

Note: Record the determined offset (number and letter) as these will be used to assemble the final implants.

Remove the trial eccenter disc using the 2.0 mm hex screw-driver. Mount the inserter / extractor onto the trial stem. Lightly tap against the inserter / extractor to back out the trial stem.

Note: To avoid possible damage to the thread, ensure that the inserter / extractor is fully threaded into the trial stem.


11Assemble implants

Instruments

E5115-5 / 1 Press

E5115-5 / 3 Eccenter / Impactor

E5115-5 / 4 Torque Wrench for Press

E5115-5 / 6– Holders for Press, sizes 6 to 14E5115-5 / 14

Choose the stem holder that corresponds to the size of the shaft. Hold the half of the stem holder with two pegs with the etched side facing up. Orient the distal end of the stem toward the operator and slide the stem over the pegs. Slide the other half of the stem holder over the pegs. This assembly allows the stem to be firmly held in the press.

Note: Ensure that the etched side of the stem holder is facing up. Improper assembly may cause jamming.

Position the eccenter on the stem. Align the letter recorded during trial implantation (step 9) with the center line of the stem. Place the assembly in the press and place the eccenter/ impactor over the eccenter. Make sure that the eccenter sits flush on the stem. Using the torque wrench, turn the handle of the press clockwise in a controlled, slow motion, until a click is heard, signifying the positive engagement of the ec-center and the stem.

Turn the torque wrench counterclockwise and remove the eccenter / impactor. Remove the stem-eccenter assembly from the press.

Notes: – Handle coated stems with care to avoid disrupting

the coating. – Ensure that the etched side is readable, to allow proper

positioning and to prevent jamming.



Remove the implant from the press. Remove the stem holder and check for adequate seating of the head and the eccen-ter.

Note: No visible gap should be present between the base of the head and the humeral stem.

Place the head on the stem assembly. Align the recorded offset position with the lateral marking on the implant or the contact line between the two halves of the stem holder.

Place the head and the stem eccenter assembly in the press. Compress components by turning the torque wrench clock-wise until a click is heard.

Remove the implant from the press by turning the torque wrench counterclockwise. Remove the stem holder from the implant.



12Implant prosthesis

Choose the final implantation method according to the type of stem being used (cemented / uncemented).

Instruments


E5115-2 Goniometer


E5115-7 Impactor

Mount the plastic liner onto the head impactor.

Remove any excess bone cement from the collar region before it sets to provide room for bone graft.

Fill the collar region with autogenous bone graft harvested from the retrieved head to improve healing between tuber-osities and shaft.

Note: Follow the manufacturer’s instructions for prepara-tion, injection and setting of the bone cement.

12aFinal implantation for cemented stems

Do a final irrigation of the medullary canal. Insert a cement restrictor to prevent excess cement from flowing into the distal humerus.

Place a vent tube in the medullary canal. Dry the cavity. In-ject cement into the canal. Remove the vent tube while the cement is being injected.

Ensure that the implant assembly is clean before inserting it. Check the final retrotorsion using the 3.0 mm retrotorsion bar.

Insert the implant, first manually, then using the head impac-tor until the predetermined anatomic prosthetic height is reached. The implant will be protruding as defined in steps 4 and 7 of this procedure.


12bFinal implantation for pressfit, cementless stems

Introduce the prosthesis into the medullary canal. To confirm proper placement and orientation of the implant, use the 3.0 mm retrotorsion bar and the goniometer to recheck the retrotorsion. Lightly tap on the head impactor with the hammer until the implant is fully seated.

The position must correspond to the predetermined ana-tomic prosthetic height. If the implant’s position is too high, more bone rasping along the medial cortex is required. If the implant finds its stable position in a location that is too dis-tal, use a shaft one size larger. Alternatively, the smaller shaft can be stabilized in the correct position using bone cement.

Note: The implant must protrude as defined in steps 4 and 7.

Fill the collar region with autogenous bone graft harvested from the retrieved head to improve healing between tuberosities and shaft.



13Pass wire-cables through stem/tuberosities

With the humeral head still in the anteriorly dislocated posi-tion, pass the wire-cables that were initially placed in step 3 through the greater tuberosity / rotator cuff junction through the medial and lateral perforations of the stem.

10 mm


14Reduce the joint

Reduce the joint i.e. the prosthetic head to the glenoid and to the greater tuberosity. Pass the wire-cable through the lesser tuberosity.

Note: After passing the wire-cable through the tuberosities and stem, cut the wire portion of the wire-cable off at the 10 mm intermediate section only.

Reduce the lesser tuberosity to the prosthesis. Use sutures to readapt the split in the rotator cuff to obtain preliminary re-duction of the tuberosities. Avoid over-reduction of the greater tuberosity, especially in a distal direction. The most medial insertion line of the supraspinatus must be fl ush with the edge of the prosthetic head, not distal to it. Fill any void under the tuberosities with cancellous bone graft harvested from the retrieved head. Use absorbable sutures for prelimi-nary reduction and adaptation of the relevant fragments.

Embrace and compress the tuberosities to the rectangular cross section of the shaft to obtain rotational stability.

Pass the end of the distal cable through the crimp and repeat the step with the proximal cable.


15Apply wire tightener and crimping pliers

Instruments

E5014-04 Crimping Pliers

E5014-05 Wire Tightener for Cerclage

Tension the cables manually but do not tighten them too much. Hold the distal cable and apply the wire tightener.

Open the cable tightening nut and pass the cable. Tighten the nut so that the cable is fi x. Before fully tightening, apply the crimping pliers over the crimp.

Note: Do not tighten the cable too much before applying the crimping pliers. Once the cable is fully tightened, apply-ing the crimping pliers will be diffi cult.



16Tighten and crimp cables

Instruments



Fully tighten the cable with the wire tightener. Crimp the cable using the pliers.

Repeat this step for the proximal cable.

Note: To prevent deformation of the tuberosities, be sure to not over-tension the cables. When using embracing cables, additional devascularizing vertical sutures between shaft and tuberosities are not necessary. The use of embracing cables requires a tenotomy and tenodesis of the biceps tendon.


17Cut the cable ends

Instrument

E5014-06 Cutting Pliers for Cerclage

Using the cutting pliers, cut the ends of the cable while hold-ing the cable.

Repeat this step for the proximal cable.



A glenoid component may be indicated in cases where there is associated cartilage damage to the glenoid or where there are irreparable glenoid fractures in which gleno-humeral stability is a concern.

Note: The size of the glenoid implant is determined by the size of the humeral head component.

Implantation of a Glenoid Component

1Approach and exposure

Adequate exposure of the glenoid is essential for implanta-tion. Exposure must permit the use of straight instruments such as reamers and drill bits. In fractures, exposure of the glenoid generally follows the space between the tubero-sities.

Introduce a tear-drop ring retractor (or another instrument such as a Fukuda Ring Retractor) to displace the greater tuberosity in a posterior and inferior direction.

Remove any remnants of the cartilage.



2Locate center point

Locate the true center of the glenoid, which is slightly infe-rior to the midpoint of Saller’s line (vertical line dividing the glenoid into anterior and posterior halves). This is the slip-page point of the humeral head during concentric motion.


3Ream glenoid

Instruments

292.260 Kirschner Wire B 2.5 mm, length 280 mm

03.401.085 Guide Extension Epoca, rigid, with Quick Coupling

E5211-4L Drill Guide, left

E5211-4R Drill Guide, right

03.401.128 Reamer Epoca B 28 mm, for Glenoid, with Quick Coupling


The shape of the drill guide matches the shape of the gle-noid implant. Determine the desired anatomic position of the glenoid implant by placing the drill guide (left or right) on the glenoid. The central hole of the drill guide should cover the center point located in step 2. Hold the drill guide in the corrected position. Introduce the 2.5 mm Kirschner wire and re-check the positioning.



Assemble the smallest reamer (28 mm) onto the rigid guide extension.

Note: Ensure the reamer and the rigid guide extension are coaxially aligned during assembly. Check that the reamer is properly attached to the rigid guide extension.

Couple the assembly to power equipment. If there is suffi-cient exposure, place the reamer assembly over the Kirschner wire, position the reamer firmly against the glenoid, and ream.

If there is not enough exposure to be able to slide the reamer over the Kirschner wire, remove the Kirschner wire. Place the reamer assembly on the glenoid, then reintroduce the Kirschner wire through the assembly into the previously drilled central hole, and ream.

OptionalAlternatively, free-hand reaming is possible without the use of guide wires. The reamer produces a uniformly concave surface, which is independent of the size of the glenoid.

Ream clockwise at high speed with steady light pressure. Windows in the reamer allow for visualization of the glenoid and the extent of reaming. During the reaming process, cor-rect the retro- or anteversion while preserving as much dense subchondral bone as possible.

Warnings: – Too much axial pressure on the reamer while reaming

weak or osteopenic bone may lead to overreaming. – While retracting the reamer, ensure that it does not

detach from the rigid guide extension.

Notes: – The reamer B 28 mm can be used for glenoids for head

B 40/42, 44 and 46. For larger glenoid sizes (48 and big-ger) continue reaming with the reamer B 32 mm to gain superior and inferior extension of the prepared surface.

– The drop shape of the drop-shaped ring retractors (avail-able in the General Shoulder Instruments Set 01.401.039) facilitate glenoid reaming by creating sufficient and com-fortable working space for the reamer.

– To facilitate cleaning of the reamers, place them in water immediately following usage.


4Prepare for trial glenoid

Instruments

292.260 Kirschner Wire B 2.5 mm, length 280 mm

E5211-4L Drill Guide, left

E5211-4R Drill Guide, right

E5211-6K Drill Bit B 7.4 mm, length 150 mm, for Glenoid and Shell Screw

E5211-6L Drill Bit B 7.4 mm, length 200 mm, for Glenoid and Shell Screw

If the Kirschner wire has been removed, reinsert it. Reintro-duce the drill guide (left or right) over the Kirschner wire. Rotate the drill guide until anatomic alignment is obtained.

Note: Use the insertion point of the biceps tendon as a landmark to determine the alignment of the longitudinal axis of the glenoid. It is recommended to position the inferior hole slightly posterior and the superior hole slightly anterior to Saller’s Line. Bone stock is typically better in this location.

Using the shorter (150 mm) drill bit, drill the distal hole first. The depth of the drill hole depends on the planned implant type.

19 mm *

21 mm *

21 mm *



4aCemented all-poly glenoid

For cemented all-poly glenoid, drill to a depth of 19 mm.

4cPressfit metalback glenoid

For pressfit metalback glenoid, drill to a depth of 21 mm.

4bHybrid glenoid with shell screws

For shell screw 10 mm, drill to a depth of 21 mm.For shell screw 15 mm, drill to a depth of 26 mm.For shell screw 20 mm, drill to a depth of 31 mm.

The smallest (10 mm) shell screw is the standard implant. Longer versions are typically used when bone defects such as comminuted anterior glenoid rim fractures require bridging.

Remove the Jacobs chuck but leave the drill bit in situ to sta-bilize the drill guide while drilling the second hole. Prepare the proximal hole using the long drill bit (200 mm). Remove the drill bits, Kirschner wire and drill guide.

*mm depth includes the height of the drill guide


5Introduce trial glenoid

Instruments

E5211-8E Holding Forceps for Trial Glenoid

E5213-42– Trial Glenoids, size 42 to 54E5213-54

Select the trial glenoid that matches the sizeof the humeral head.

Trial Glenoids

Head size 40 42 44 46 48 50 52 54

Trial size 40/42 40/42 44/46 44 /46 48/50 48/50 52/54 52/54

Art. No. E5213–42 E5213–42 E5213–46 E5213–46 E5213–50 E5213–50 E5213–54 E5213–54



Use the trial glenoid holding forceps to insert the trial gle-noid. Check the fit of the trial implant and ensure that the rear surface of the trial fits firmly to the reamed surface of the glenoid. If not, additional reaming of the glenoid is re-quired. Alternatively, gaps may be filled with autogenous bone graft.

In case of a comminuted anterior glenoid rim fracture, the glenoid implant is stabilized by 15 or 20 mm shell screws while the fracture fragment can be reduced and fixed with a simple osteosuture.

Note: A simple suture loop to readapt the radial labral tear occurring at the 2 o’clock position is often sufficient.


6Implant glenoid component

Instruments


E5211-8 Holding Forceps for Glenoid

F017-4.5 Screwdriver, hexagonal, width across 4.5 mm

F017-2.5 Screwdriver, hexagonal, width across 2.5 mm

E5211-10 Glenoid Impactor

E5221-1 Metalback Impactor

E5221-2 Drill Sleeve 2.5 (22)

E5221-3 Drill Bit B 2.5 mm

03.401.081 Tap for Epoca Shell Screws, length 200 mm

03.401.082 Insertion Guide for Epoca Shell Screws

03.019.005 Handle with Quick Coupling, length 150 mm

Ensure that the plastic impactor liner is mounted on the glenoid impactor.

Option A. Cemented all-poly glenoidClean and dry the drilled cavities. Consider using a suction device introduced through the base of the coracoid process to evacuate undesired fluids. Introduce a small amount of bone cement (methylmethacrylate) into the two drilled cavi-ties (0.15 ml in each cavity) using a 1 ml syringe.

Note: Avoid overflow of the cement onto the faceplate of the glenoid as this will lead to a thin and brittle cement layer. Consult the manufacturer’s instructions for proper bone cement usage.



Mount the glenoid implant on the special holding forceps and introduce the implant in the correct orientation (the nar-row part facing up). Introduce the glenoid implant and seat it into its final position with light hammer taps on the glenoid impactor.


Option B. Hybrid glenoid (with shell screws)Position the insertion guide for the shell screws over the guide wire.

Optional (in cases of dense or sclerotic bone)Align the insertion guide with the pre-drilled holes and man-ually tap using the tap for Epoca Shell Screws.

Note: The color coding on the tap corresponds to the shell screw lengths (10 mm = green, 15 mm = blue, 20 mm = yellow).

Insert the previously selected shell screws (see step 5) with the long, 4.5 mm, hexagonal screwdriver.

The shell screw should be slightly below the surface of the bone.

Note: The shell screws can be inserted with or without the use of the insertion guide for Epoca Shell Screws.



Place the glenoid implant in position using the glenoid hold-ing forceps. Set the glenoid implant into place using the hammer and glenoid impactor.

Introduce a small amount of bone cement (0.13 ml methyl-methacrylate) into each shell screw using a 1 ml syringe.

Note: Avoid overflow of the cement onto the faceplate of the glenoid, as this will lead to a thin and brittle cement layer. Consult the manufacturer’s instructions for bone cement usage.


Option C. Pressfit metalback glenoidPlace the metalback glenoid implant in position using the metalback impactor. Lightly tap the glenoid implant into place using the hammer and glenoid impactor.

Note: The metalback glenoid can be fixed with 3.5 mm cor-tex screws at the bottom of the pegs for additional stability.

OptionalAdditional screw fixation depends upon surgeons’ intraoper-ative judgment and preference. For this purpose, a special aiming drill guide is available. Introduce the cylindrical drill guide in the cylindrical metal-back peg and drill with a 2.5 mm drill bit. Measure the screw length and introduce a standard 3.5 mm cortical screw.



Place the glenoid implant in position using the glenoid hold-ing forceps. Set the glenoid implant into place using the hammer and glenoid impactor.

7Complete implantation of humeral component

Remove the humeral retractors and expose the proximal humerus. Complete implantation of a standard humeral component.


E5115-5/1 Press Epoca

519.970 Oil Dispenser with Synthes Special Oil, 50 ml

Note: Synthes special oil is to be applied to the Epoca Press just prior to sterilization. To ensure proper performance, oil the following locations and repeat as necessary until a noticeable smooth actuation of the screw mechanism is achieved.

Failure to apply oil prior to use may cause undesired performance and lack of calibrated force upon the implant assembly.

Note: The autoclavable oil is purchased separately.

For best results turn the press with torque wrench clockwise and counterclockwise until smoother movement is noticed.

Care and Maintenance




Humeral Stem, uncemented – Titanium alloy (TAV) with Ti+HA coating – Also for Nickel sensitive Patients

Art. No. Size (mm) Length (mm)

5528-6/11 6 115

5528-8/12 8 120

5528-10/12 10 125

5528-12/13 12 130

5528-14/13 14 135

Implants(all Implants are sterile packed)

Humeral Stem, cemented – Stainless Steel

Art. No. Size (mm) Length (mm)

5614-6/11 6 115

5614-8/12 8 120

5614-10/12 10 125

5614-12/13 12 130

5614-14/13 14 135


Titanium Eccenter – Titanium alloy (TAV)

Art. No. Usage

5413-20/5 Standard

Head – Stainless Steel

Art. No. B (mm) Height (mm)

5311–40/15 40 15.00

5311–42/15 42 15.75

5311–44/16 44 16.50

5311–46/17 46 17.25

5311–48/18 48 18.00

5311–50/18 50 18.75

5311–52/19 52 19.50

5311–54/20 54 20.25

5311–56/21 56 21.00 optional

5311–58/22 58 21.75 optional

Glenoid – UHMW polyethylene – Can be used as stand alone component or in combination

with Shell Screws or Metalback component

Art. No. For Head B (mm)

5213–42 40 and 42

5213–44 44

5213–46 46

5213–48 48

5213–50 50

5213–52 52

5213–54 54

5213–56 56 optional

5213–58 58 optional


Implants

Shell Screws for hybrid Glenoid – Titanium alloy (TAV) – For use with Polyethylene Glenoid component

Art. No. Length (mm) Glenoid

5114-9/10 10 5213-42 to 5213-58

5114-9/15 15 5213-42 to 5213-58

5114-9/20 20 5213-42 to 5213-58

Metalback component for cementless Glenoid – Titanium alloy (TAV) – For use with Polyethylene Glenoid

Art. No. Size Glenoid

5118-42 40 + 42 5213-42

5118-46 44 + 46 5213-44 / 5213-46

5118-50 48 + 50 5213-48 / 5213-50

5118-54 52 + 54 5213-52 / 5213-54

Cortex Screw B 3.5 mm – Optional for use with Metalback Glenoid

Art. No. Length (mm)

404.010S 10

404.012S 12

404.014S 14

404.016S 16

404.018S 18

404.020S 20

404.022S 22

404.024S 24

404.026S 26

404.028S 28

404.030S 30


Tubercable – Stainless Steel – For Tubercula Refi xation in Trauma surgery

Art. No. B (mm)

9014-6/50 1.0

Wire-cable

02.401.000S Wire-Cable B 1.0 mm, with Crimp


Head for Allergy Patients – Stainless Steel, with TiNb coating

Art. No. B (mm) Height (mm)

5321–40/15 40 15.00

5321–42/15 42 15.75

5321–44/16 44 16.50

5321–46/17 46 17.25

5321–48/18 48 18.00

5321–50/18 50 18.75

5321–52/19 52 19.50

5321–54/20 54 20.25

5321–56/21 56 21.00 optional

5321–58/22 58 21.75 optional

Special Implants(all Implants are sterile packed)

Stem for Allergy Patients, sterile – See Humeral Stem, uncemented (Titanium alloy TAV) – Art. No. 5528-6/11 to 5528-14/13


Instruments


E5112-1 Starter Rasp Epoca, size 6

E5115-1 Retrotorsion Bar Epoca B 6.0 mm

E5115-2 Goniometer Epoca

01.401.110 Epoca Humerus: Stem instruments

68.401.112 Modular Tray for Humeral Stem Epoca, Trial Instruments, size 1/1, without Contents, Vario Case System

68.401.113 Modular Tray for Humeral Stem Epoca, Rasp Instruments, size 1/1, without Contents, Vario Case System

Note: The instrument set 01.401.110 also contains the empty additional modular tray 68.401.111.


E5112-6 Rasp Epoca, size 6





E5115-3 Slotted Hammer/Extractor Epoca

E5113-6 Trial Stem Epoca, size 6





E5115-6 Retrotorsion Bar Epoca B 3.0 mm

E5115-4/2 Screwdriver Epoca, width across 2.0 mm, for Trial Implants

E5115-4/3 Screwdriver Epoca, width across 2.5 mm, for Trial Implants

Instruments


E5117-20 Trial Eccenter Disc Epoca

E5114-40 Trial Head Epoca, size 40



E5114-46 Trial Head Epoca, size 46E5114-48 Trial Head Epoca, size 48




E5114-56 Trial Head Epoca, size 56 (optional)

E5114-58 Trial Head Epoca, size 58 (optional)

E5115-8/38 Humeral Cover Epoca B 38 mm, for Trial Stem



E5115-7 Impactor Epoca

03.401.083 Ruler, length 250 mm, Stainless Steel (optional)

03.401.084 Curette, oval, with Toothing, length 300 mm (optional)


E5115-5/4 Torque Wrench Epoca, for Press

E5115-5/1 Press Epoca

E5115-5/6 Holder Epoca for size 6, for Press





E5115-5/3 Eccenter/Impactor Epoca

Instruments

01.401.120 Epoca Humerus: Press instruments

68.401.032 Vario Case for Epoca Humerus Press Instruments


E5211-4L Drill Guide Epoca, left

E5211-4R Drill Guide Epoca, right

292.260 Kirschner Wire B 2.5 mm with trocar tip, length 280 mm, Stainless Steel

03.401.085 Guide Extension Epoca, rigid, with Quick Coupling

01.401.130 Instruments Epoca Glenoid

68.401.131 Modular Tray for Epoca Glenoid, Insertion Instruments, size 1/1, without Contents, Vario Case System

68.401.132 Modular Tray for Epoca Glenoid, Preparation Instruments, size 1/1, without Contents, Vario Case System


E5211-6L Drill Bit Epoca B 7.4 mm, length 200 mm, for Glenoid and Shell Screw

E5211-6K Drill Bit Epoca B 7.4 mm, length 150 mm, for Glenoid and Shell Screw

E5211-8E Holding Forceps Epoca for Trial Glenoid

Instruments



03.401.081 Tap for Epoca Shell Screws, length 200 mm

03.401.082 Insertion Guide for Epoca Shell Screws

03.019.005 Handle with Quick Coupling, length 150 mm


E5213-42 Trial Glenoid Epoca, size 42




F017-4.5 Screwdriver Epoca, hexagonal, width across 4.5 mm

E5221-1 Metalback Impactor Epoca

E5211-8 Holding Forceps Epoca for Glenoid

E5211-10 Glenoid Impactor Epoca


Instruments

E5221-2 Drill Sleeve Epoca 2.5 (22)

E5221-3 Drill Bit Epoca B 2.5 mm

F017-2.5 Screwdriver, hexagonal, Epoca, width across 2.5 mm

338.080 DHS/DCS T-Handle with Quick Coupling (optional)


Additional instruments

03.401.086 Adapter for Quick Coupling to Epoca Reamer Thread

Spare parts

E5114-1 Spare Screws for Trial Head Epoca

E5115-7P Impactor Head Epoca

E5211-10P Synthetic Headpiece for Impactor for Glenoid

E5211-3 Wrench Epoca, width across 10


E5014-06 Cutting Pliers for Cerclage

Cerclage Instruments



Instruments

Notes: – Ordering information for the General Shoulder Instru-

ments Sets can be found in the brochure 036.000.823. – Ordering information for the Epoca Revision Instruments

can be found in the Surgical Technique 036.001.070.


Stanley Hoppenfeld and Piet deBoer, Surgical Exposures in Orthopaedics–The Anatomic Approach, Third Edition, 2003, pp. 2–8.

Hertel R, Knothe U, Ballmer FT. Geometry of the proximal humerus and implications for prosthetic design. J Shoulder Elbow Surg. 2002;11(4):331-8.

Hempfing A, Leunig M, Ballmer FT, Hertel R. Surgical land-marks to determine humeral head retrotorsion for hemi-arthroplasty in fractures. J Shoulder Elbow Surg. 2001;10(5):460-3.

Bibliography


MRI Information

Torque, Displacement and Image Artifacts according to ASTM F 2213-06, ASTM F 2052-06e1 and ASTM F2119-07Non-clinical testing of worst case scenario in a 3 T MRI system did not reveal any relevant torque or displacement of the construct for an experimentally measured local spatial gradient of the magnetic field of 3.69 T/m. The largest image artifact extended approximately 169 mm from the construct when scanned using the Gradient Echo (GE). Testing was conducted on a 3 T MRI system.

Radio-Frequency-(RF-)induced heating according to ASTM F2182-11aNon-clinical electromagnetic and thermal testing of worst case scenario lead to peak temperature rise of 9.5 °C with an average temperature rise of 6.6 °C (1.5 T) and a peak temperature rise of 5.9 °C (3 T) under MRI Conditions using RF Coils [whole body averaged specific absorption rate (SAR) of 2 W/kg for 6 minutes (1.5 T) and for 15 minutes (3 T)].

Precautions: The above mentioned test relies on non-clin-ical testing. The actual temperature rise in the patient will depend on a variety of factors beyond the SAR and time of RF application. Thus, it is recommended to pay particular attention to the following points: – It is recommended to thoroughly monitor patients under-

going MR scanning for perceived temperature and/or pain sensations.

– Patients with impaired thermo regulation or temperature sensation should be excluded from MR scanning proce-dures.

– Generally it is recommended to use a MR system with low field strength in the presence of conductive implants. The employed specific absorption rate (SAR) should be reduced as far as possible.

– Using the ventilation system may further contribute to reduce temperature increase in the body.

0123

Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com

This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.depuysynthes.com/ifu ©

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Epoca Shoulder Arthroplasty System – Fracture. Hemi and ...

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