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Epoca Revision Set. Instrumentation for extraction and revision of Epoca shoulder implants.

Surgical Technique

This publication is not intended for distribution in the USA.

Instruments and implants approved by the AO Foundation.

Epoca Revision Set Surgical Technique DePuy Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

MRI Information 32

Introduction 2

Epoca Revision Set 4

Intended Use 6

Removal / Extraction: Humeral Components 7

Removal: Glenoid Components 12

Implantation: Long or Extra-long Stem 20

Implantation: Head without Stem Change 22

Implants 24

Instruments 26

Optional Instruments 29

Sets 30

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 Revision Set Surgical Technique

Introduction

Revision procedures differ from case to case. The operative strategies must be adapted to the specific case, therefore making preoperative planning one of the main determining factors for a successful outcome.

The following key elements must be assessed preoperatively: – Patient medical history – Individual characteristics of the patient (e.g. bone quality,

activity level) – Implants to be extracted / revised (e.g. type of implant,

type of fixation, stability)

The assessment of these elements influences the operative strategy, i.e. whether a longitudinal corticotomy is needed for removal and what type of implant can be re-implanted.

The following instrument sets are needed depending on what implant component is to be revised. It is important that the necessary selection of revision implants is available at the time of surgery.

Extraction / Removal of implants

Art. No. Required instruments sets

Head and eccenter removal

Humeral stem extraction

Glenoid component removal

Reco glenoid removal

Epoca RH removal

01.401.040 Instruments Epoca Revision • • • •01.401.110 Instruments Epoca Humerus • • •01.401.130 Instruments Glenoids Epoca •01.401.140 Instruments Epoca RH •01.401.150 Instruments Epoca Reco Glenoid •01.401.039 General Shoulder Instruments Set • • • • •01.900.022 Extraction Module for Screws

B 3.5, 4.0, 4.5 mm • •


Implantation of a long humeral stem

Art. No. Required instruments sets

Implantation of long humeral stems

01.401.040 Instruments Epoca Revision •01.401.110 Epoca Humerus : Stem instruments •01.401.120 Epoca Humerus : Press instruments •01.401.038 Instruments Cable System Epoca •01.401.039 General Shoulder Instruments Set •189.060 SynReam Set in Vario Case •105.596 Reaming Instrument Set for Humerus •


Removal / Extraction of humeral componentsDedicated instruments for removal and extraction of humeral components are available. They are used with the same guide bar and the ram to gently re-move the implant.

Articulated eccenter extractor – For simple removal of eccenter – Is always centered when attached

to eccenter

Stem extractor – For atraumatic removal of the pros-

thesis stem

Articulated head extractor – For simple removal of the prosthesis

head – Self-centering independent of head

size so that forces are applied axially – Compatible with all Epoca heads

(B 40 – 58 mm)

Implantation of a long or extra-long humeral stemIn certain cases, long or extra-long stems must be implanted. The following instruments are available to facilitate implantation.

Epoca Revision Set. Instrumentation for Extraction and Revision of Epoca Shoulder Implants.

Removal/Extraction

Implantation

Trial stems for long and extra-long stem implants – Facilitate decision-making about

correct stem implant size

Short reaming rod 2.5 mm – Length adapted for use in humerus – Renders humerus reamers more

rigid to facilitate reaming in revision cases


Removal of glenoid componentsBone-preserving removal of implants is essential in glenoid revision surgery. Used with general instruments, the following instruments can be used to remove Epoca glenoid components:

Conical extraction screw – Reverse thread functions like exist-

ing screw removal instruments – Long shaft facilitates approach – For use with chisel handle – Bone-preserving removal of shell

screws / metalback pegs

Carbide drill bit – Removal of metalback glenoid – For use with drill suction device

Drill sleeve for drill suction device – Prevents metal debris in the joint – Can be used with the drill suction

device

General instrumentsGeneral instruments, such as a chisel, osteotomes/handle and an awl com-plete the set.


The Epoca Revision Set is intended for the extraction and revision of Epoca Shoulder System implants.

Application of Epoca revision instruments

Intended Use

03.401.070 Guide Bar for Removal of Implants• • •

355.250 Ram• • •

03.401.071 Articulated Head Extractor, for Guide Bar No. 03.401.070 •

03.401.072 Stem Extractor, for Guide Bar No. 03.401.070 •

392.919 Wrench, hexagonal B 5.0 mm, long, angled •

03.401.073 Articulated Eccenter Extractor, for Guide Bar No. 03.401.070 •

03.401.075S Carbide Drill Bit B 9.5 mm, for Instrument Steel and Titanium, sterile •

03.401.076 Extraction Screw, conical, for inner diameter 7.0 mm • •

03.607.106 Extension for Carbide Drill Bit B 6.0 mm •03.607.110 Drill Suction Device

•03.607.095 Drill Sleeve 9.5, clip-on, for No. 03.607.110

•03.111.012 Handle, long, with Quick Coupling

• • • • • • •03.111.016 Chisel, for Foot, straight, wide,

width 15 mm, length 124 mm • • • • • • •399.820 Osteotome, width 10 mm, length 150 mm

• • •391.880 Vice Grip, length 180 mm

•310.600 Drill Bit B 6.0 mm, length 195 /170 mm,

2-flute, for Quick Coupling • • • •359.213 Awl for TEN

• • • • •E5113-6L– 14XL

Trial Stems Epoca, long or extra-long, size 6–14 •

03.401.074 Reaming Rod B 2.5 mm, short, length 400 mm •

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Art. No. Description

• = optional


Removal / Extraction: Humeral Components

1Preoperative planning

Preoperative planning includes deciding whether a short or long stem shall be re-implanted. It should be decided whether the extraction requires a longitudinal corticotomy or not.

Note: Please ensure that long and / or extra-long stem im-plants and instruments are available in all revision cases of the humeral component.

2Patient positioning and approach

Patient positioning is generally beach chair. The approach is generally deltopectoral. Expose the joint after subscapularis detachment with or without osteotomy of the lesser tuber-osity. Consider soft-tissue releases to expose the head.


3Head/eccenter removal and humeral stem extraction

Instruments

03.401.070 Guide bar for removed of implants

355.250 Ram

03.401.071 Articulated head extractor

03.401.073 Articulated eccenter extractor

03.401.072 Stem extractor

392.919 Wrench, hexagonal B 5.0 mm, long, angled

Optional instruments

03.111.012 Handle, long, with Quick Coupling

03.111.016 Chisel, straight, wide, width 15 mm, length 124 mm

391.880 Vice grip, length 180 mm

359.213 Awl

399.820 Osteotome, width 10 mm, length 150 mm

Mount the articulated head extractor on the prosthetic head. Pass the guide bar through the ram, screw the guide bar into the articulated head extractor. Make sure the thread fully catches. Apply gentle blows with the ram.

Note: The head typically comes off without the eccenter.



Mount the articulated eccenter extractor (if necessary, use the vice grip to rotate the eccenter into a more favorable position). Mount the ram/guide bar and apply gentle blows.

Note: If the articulated extractor instruments cannot be mounted correctly, carefully tap in two thin osteotomes be-tween the stem and eccenter/head.

Precaution: Do not damage the surrounding soft tissues when using the chisel. Pay attention that the articulated head extractor or the articulated eccenter extractor do not slip off as this could damage the surrounding soft tissues.


To remove the stem, mount and fully tighten the stem ex-tractor using the hexagonal wrench. Mount the ram/guide bar and apply gentle blows.

To ease stem extraction, the proximal bone/implant interface can be gently released using thin osteotomes.

Retighten the guide bar/extraction tool connection after a couple of blows to make sure that it is not loose.

Note: If the stem does not readily loosen, consider perform-ing a longitudinal corticotomy before irreparable damage to the humerus occurs.

Remove any residual bone cement as necessary using stan-dard techniques and tools.



4Removal of an Epoca resurfacing head

To remove a resurfacing head, resect the humeral head following the anatomical neck using an oscillating saw.

Note: Pay attention not to damage the insertion line of the rotator cuff.

If necessary, correct the resection plane.

Continue with the implantation of a hemi- or total prosthesis as described in the Epoca Surgical Technique 036.000.960.



Patient positioning is generally beach chair. The approach is generally deltopectoral.

Removal: Glenoid Components


2Remove glenoid components

2aCemented all-poly glenoid removal

Instruments




310.600 Drill Bit B 6.0 mm, length 195/170 mm, 2-flute, for Quick Coupling

359.213 Awl

Slide a chisel between the face plate of the polyethylene glenoid and the glenoid. Mobilize the PE using slight tilting movements. Extract the implant with a forceps.

Note: If it is not possible to extract the PE en-bloc you may cut the PE pegs with the chisel and then overream the PE pegs with a 6 mm drill bit.

Precaution: Pay attention not to damage the surrounding soft tissues when using the chisel.

Remove any residual bone cement using standard tools and techniques.


2bHybrid glenoid / shell screws removal

Instruments



03.401.076 Extraction Screw, conical, for inner diameter 7.0 mm



359.213 Awl

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

359.221 Combined Hammer

Remove the PE glenoid as described in step 2a.

Note: If the PE pegs remain within the shell screws, overdrill the PE with a 6 mm drill bit. Remove PE residuals.

Attach the conical extraction screw to the handle and lightly hammer it into the shell screw. Turn in a counterclockwise direction. The conus will gain purchase inside the shell screw and the shell screw will begin to back out.

Precaution: Do not apply too much force when hammering the conical extraction screw into the shell screws as this could damage the threads of the extraction screw and /or cause an iatrogenic glenoid fracture.

Alternatively, the shell screws can be removed after ex-traction of the bone cement using the standard hexagonal screwdriver.



2cMetalback glenoid removal

Instruments

03.401.075S Carbide Drill Bit B 9.5 mm, for Instrument Steel and Titanium, sterile

03.607.106 Extension for Carbide Drill Bit

03.607.110 Drill Suction Device

03.607.095 Drill Sleeve 9.5, clip-on, for No. 03.607.110

03.111.016 Chisel, for Foot, straight, wide, width 15 mm, length 124 mm


03.401.076 Conical extraction screw, for inner diameter 7.0 mm



359.213 Awl

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

359.221 Combined Hammer

Remove the PE glenoid implant as described in step 2a.

Note: If the PE pegs remain within the metalback, use a 6.0 mm drill bit to overream them.

In case of additional cortical screw fixation, extract the screws with a 3.5 mm screwdriver.

First, try removing the metalback glenoid using a chisel. If the metalback glenoid cannot be removed using the chisel, continue with the following steps.


Prepare drill suction deviceBefore drilling attach the 9.5 mm drill sleeve to the drill suc-tion device. Then connect the drill suction device to the irrigation system and the vacuum pump. To release the drill sleeve, press the side flange.

Warning: Drilling metal causes drill chips, which need to be suctioned away. It is also important to cool the drill bit during the drilling process. The use of the drill suction device allows an efficient aspiration of the drill chips while at the same time cooling the drill bit.

Mount drill bit onto extension for carbide drill bit1. Attach the extension to the universal chuck of the power

tool.2. Tighten.3. Open the sleeve of the extension by turning the nut (left-

hand thread).4. Attach the drill bit to the extension. Ensure that the drill

bit fit is mounted accurately on the sleeve of the exten-sion.

5. Manually close the sleeve.

Note: It is not advisable to tighten the nut with a pin wrench. When releasing the nut the pin wrench may, how-ever, be useful, as the drilling process itself can tighten the left-hand thread of the extension.



Start drilling processSwitch on the rinsing equipment and the vacuum pump. Position the drill suction device on the metalback plate/peg junction. Insert the 9.5 mm carbide drill bit into the drill sleeve and start drilling at the plate/peg junction to separate the plate from the peg. Repeat this step for the second peg.

Carefully remove all metal debris.

Precautions: – Do not interrupt the water supply. Ensure that the supply

and waste hoses are not bent. – Make sure that there is no more metal debris in the joint

as this could harm the revised joint replacement. – Note that the carbide drill bit may not be reprocessed or

resterilized. Since it is used to drill metal which may cause damage during use, the drill bit is designed for single use only.

– Metal drill bits are hard and brittle. To prevent breakage, start drilling with the drill bit already revolving while main-taining the chosen drill axis throughout the drilling pro-cess.

– While drilling, do not exert excessive forces on the drill by pushing. Instead, gently oscillate the drill back and forth.

Carefully slide a chisel under the titanium plate to remove it.

Precaution: Pay attention not to damage the surrounding soft tissues when using the chisel.


Attach the conical extraction screw to the handle and lightly hammer it into the first peg as described for the shell screws in step 3. Turn in a counterclockwise direction to engage the extraction screw. Continue turning in a counterclockwise direction. Then extract the pegs applying axial force.

Precaution: Do not apply too much force when hammering the conical extraction screw into the pegs as this could dam-age the peg / threads of the extraction screw and / or cause an iatrogenic glenoid fracture.



2dRemove reconstruction glenoid

Instruments

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



359.213 Awl

Optional instrument


Use a chisel to remove the PE inlay. Use the awl to expose the screw heads by removing residual cement. Untighten and remove the screws. In case the screws cannot be re-moved, use the screw extraction module. Carefully slide the chisel between the glenoid and the metal-back support to remove it.

Note: It could occur that the central PE peg remains in the glenoid. In this case use a 6.0 mm drill to remove it.

Precaution: Pay attention that the awl does not slip off as this could damage the surrounding soft tissues.



Patient positioning is generally beach chair. The approach is generally deltopectoral.

Implantation: Long or Extra-long Stem


2Preparation of medullary canal

Sets

105.596 Reaming Instrument set for Humerus (reamer diameters 6–10.5 mm)and/or189.060 SynReam Set (reamer diameters 8.5–16 mm)

01.401.110 Epoca Humerus: Stem instruments

Instruments

03.401.074 Reaming Rod B 2.5 mm, short, length 400 mm

E5113-6L – Trial Stems Epoca, long, sizes 6–14E5113-14LorE5113-6XL – Trial Stems Epoca, extra-long, sizes 6–14E5113-14XL

Introduce the 2.5 mm reaming rod, slide the reamer head and the reamer shaft over the reaming rod and gently ream until the desired diameter is reached. Consider that the humeral diaphysis might be relatively thin.

Precaution: Do not penetrate the humeral cortex with either the reaming rod or the reamer.

Note: Check the reaming rod for damages before using it. Otherwise the reamer heads and the reamer shaft cannot advance smoothly.

Prepare the proximal part with standard rasps. Probe the cor-rect implant size with the long stem trial implants.

Continue with the implantation of a hemi- or total prosthesis as described in the Epoca Surgical Technique 036.000.960.


1Extract head

Extract the head as described in chapter one, Removal / Extraction of Humeral Components.

2Attach trial eccenter disc

Sets

01.401.110 Epoca Humerus: Stem instruments

01.401.120 Epoca Humerus: Press instruments

Use a surgical marker pen to extend the midline marking on the stem onto the adjacent soft tissues (supraspinatus and calcar).

Implantation: Head without Stem Change


Insert the trial eccenter into the trial head in position A. Mount the construct onto the stem and check for optimal offset. Should the offset be inadequate, extract the con-struct, adjust the offset (e.g. to position B) and recheck the position.

After determination of the required offset, record the combi-nation.

Mount the revision eccenter on the head in the correct position. Place the eccenter/head construction onto the ec-center/impactor Epoca. Place the eccenter/impactor Epoca upside down into the press. Using the torque wrench, turn the handle of the press clockwise until a click is heard, signi-fying the positive engagement of the eccenter and the head. Introduce the assembly onto the prosthetic shaft. Rotate it to the correct position in respect to the soft-tissue marking. Use the head impactor and apply gentle blows with a hammer.

Note: Be sure that the basis of the head sits flush onto the neck of the stem.


Implants

All implants are sterile packed.

Humeral Stem, long, cementedStainless Steel

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

5614-6/15L 6 155

5614-8/16L 8 160

5614-10/16L 10 165

5614-12/17L 12 170

5614-14/17L 14 175

Humeral Stem, extra-long, cementedStainless Steel

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

5614-6/19XL 6 195

5614-8/20XL 8 200

5614-10/20XL 10 205

5614-12/21XL 12 210

5614-14/21XL 14 215


Revision eccenterTitanium alloy (TAV)

Art. No. Usage

5413-20/6REV Revision

The revision eccenter is slightly thicker in diameter than the standard eccenter. The increased thickness allows for a pressfit connection between the original stem and the head implant.

For standard Epoca implants, please refer to the following Surgical Techniques: – 036.000.960 – Epoca Shoulder Arthroplasty System –

Stem and Glenoid. Components for degenerative and posttraumatic conditions.

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

– 036.000.964 – Epoca Shoulder Arthroplasty System. Reconstruction glenoid for rotator cuff deficiencies.

– 036.000.966 – Epoca Shoulder Arthroplasty System – Resurfacing Head RH. Resurfacing head for degenerative conditions.


Instruments



03.401.070 Guide Bar for Removal of Implants Used with 355.250.

03.401.071 Articulated Head Extractor, for Guide Bar No. 03.401.070. Used with 355.250.

03.401.072 Stem Extractor, for Guide Bar No. 03.401.070. Used with 355.250.


03.401.073 Articulated Eccenter Extractor, for Guide Bar No. 03.401.070. Used with 355.250.

03.401.074 Reaming Rod B 2.5 mm, short, length 400 mm

03.401.075S Carbide Drill Bit B 9.5 mm, for Instrument Steel and Titanium, sterile.

Used with 03.607.106.

Note: The carbide drill bit may not be reprocessed or resteril-ized. Since it is used to drill metal which may cause damage during use, the drill bit is designed for single use only.

03.401.076 Extraction Screw, conical, for inner diameter 7.0 mm

03.607.095 Drill Sleeve 9.5, clip-on, for No. 03.607.110


E5113-6L– Trial Stems Epoca, long, sizes 6–14 E5113-14L

E5113-6XL– Trial Stems Epoca, extra-long, E5113- 14XL sizes 6–14

03.607.106 Extension for Carbide Drill Bit B 6.0 mm

03.607.110 Drill Suction Device

355.250 Ram. Used with Guide Bar No. 03.401.070.

Instruments


Spare Parts

310.600 Drill Bit B 6.0 mm, length 195/170 mm, 2-fl ute, for Quick Coupling

359.213 Awl for TEN

391.880 Vice Grip, length 180 mm

03.401.077 Screw M6 x 18 for No. 03.401.072

03.401.078 Nut M8 for Nos. 03.401.071and 03.401.073

Optional Instruments


Sets

01.401.040 Epoca Revision Instruments68.401.042 Naming clip for Epoca Revision Instruments689.511 Vario Case, Framing, size 1/1, height 126 mm689.507 Lid (Stainless Steel), size 1/1, for Vario Case

Instruments

Modular tray 1 Qty

68.401.040 Modular tray for removal 1 instruments, Epoca Revision, size 1/1, without content

03.401.070 Guide Bar for Removal of Implants 1

03.401.071 Articulated Head Extractor, 1 for Guide Bar No. 03.401.070

03.401.072 Stem Extractor, for Guide Bar 1 No. 03.401.070

03.401.073 Articulated Eccenter Extractor, 1 for Guide Bar No. 03.401.070

03.401.075S Carbide Drill Bit B 9.5 mm, 1 for instrument Steel and Titanium

03.401.076 Extraction Screw, conical, 1 for inner diameter 7.0 mm

355.250 Ram 1

03.607.106 Extension for Carbide Drill Bit B 6.0 mm 1

03.111.012 Handle, long, with Quick Coupling 1

03.111.016 Chisel, for Foot, straight, wide, 1 width 15 mm, length 124 mm

03.607.110 Drill Suction Device 1

03.607.095 Drill Sleeve 9.5, clip-on, 1 for No. 03.607.110

392.919 Wrench, hexagonal B 5.0 mm, 1 long, angled

399.820 Osteotome, width 10 mm, 2 optional length 150 mm

391.880 Vice Grip, length 180 mm 1 optional

310.600 Drill Bit B 6.0 mm, 1 optional length 195/170 mm, 2-flute, for Quick Coupling

359.213 Awl for TEN 1 optional

Please note that the carbide drill bit is only available sterile packed.


Instruments

Modular tray 2 Qty

68.401.041 Modular tray for trial stems, 1 Epoca Revision, size 1/1, without content

E5113-6L Trial Stem Epoca, long, size 6 1





E5113-6XL Trial Stem Epoca, extra-long, size 6 1





03.401.074 Reaming Rod B 2.5 mm, short, 2 length 400 mm


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-clini-cal 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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