surgical technique - smith & nephe...1710: promos™ reverse humeral components 1711: promos...

Surgical Technique

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PROMOS™ REVERSE Modular Shoulder System

Nota BeneThe technique description herein is made available to the healthcare professional to illustrate the author’s suggested treatment for the uncomplicated procedure. In the final analysis, the preferred treatment is that which addresses the needs of the specific patient.

Table of Contents Introduction .................................................................................... 2

Indications/Contraindications ....................................................... 3

Preoperative Planning ................................................................... 4

Patient Positioning ......................................................................... 5

Surgical Technique ........................................................................ 6

Revision Surgery ........................................................................... 36

Sterilization ................................................................................... 40

Implants ......................................................................................... 41

Instrumentation ........................................................................... 43

Introduction

The anatomical PROMOS™ modular shoulder prosthesis has been successfully applied as a standard cementless implant since 2003 and is indicated for primary and secondary omarthrosis and fractures. The modular PROMOS STANDARD prosthesis range can be expanded with the PROMOS REVERSE prosthesis component to extend the indications of the PROMOS system. The use of this modular extension is planned for arthrosis with advanced irreparable rotator cuff rupture, where conventional shoulder prosthesis would no longer provide sufcient pain-free joint stability or an adequate range of motion.

The PROMOS REVERSE implant reverses the normal relationship of the scapular and humeral components of the glenohumeral joint. This allows stabilization and leads to the desired medialization and distalization of the rotational center. The reversal of the joint allows the three parts of the deltoid muscles to compensate for the insufficiency of the rotator cuff, to bring the articulation surfaces together and to stabilize the joint. This allows what is tantamount to normal joint function to be restored.

The PROMOS Shoulder System uses the same distal shaft components for the standard prosthesis as for the reverse prosthesis. The proximal components for both systems can be added or removed in a modular system. The reverse prosthesis can therefore be used for primary treatment as well as for revisions following inadequate healing or resorption of the tubercle or can be used following secondary rotator cuff rupture. A standard body with a humeral head component can also be used if the glenoid components loosen or following a glenoid fracture as a last resort, while still maintaining the prosthesis shaft.

The distal rectangular shaft is the ideal basis for a rotationally stable diaphyseal anchorage in the humerus.

The distal anchorage allows major parts of the metaphyseal bone substance to be maintained in primary surgery, while still allowing a stable diaphyseal anchorage without bone transplantation in revision surgery with bone defects.2

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Indications/Contraindications

Indications• The PROMOS™ REVERSE Shoulder is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint• The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device• The glenoid baseplate is intended for cementless application with the addition of screws for fixation• The humeral stem and body components are intended for cementless use

Contraindications• Complete palsy of the brachial plexus or axillary nerve• Primary osteoarthritis or osteonecrosis when the articular surface-tuberosity relationships are normal and the rotator cuff is intact and functional. In this case a PROMOS STANDARD Shoulder is indicated• Acute or chronic infections, local or systemic• Infected operation site• Severe muscular, neurological or vascular diseases that have the potential to endanger the extremity in question• Too little bone substance or excessively poor bone quality, endangering the stable seating of the prosthesis• Any concomitant diseases that endanger the function of the implant, such as: – Allergy to the implant materials – Severe renal insufficiency – Severe cardiac insufficiency (e.g. due to increased metal-ion concentrations in the blood)• Pregnancy• Neuropathic shoulder (Charcot shoulder)

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Preoperative planning should be carried outwith the existing X-Ray templates to evaluatepossible implant size and position of the implant.X-Ray pictures should be taken in true A/Pand axillary views.

Literature numbers for preoperative templates1710: PROMOS™ REVERSE Humeral Components1711: PROMOS REVERSE Glenoid Components

Implant templates are available at 110% magnification.

Preoperative Planning

The resection level on the humeral template at the upper edge of the reverse body is placedover the X-Ray image. The resection line will be placed slightly (1–2mm) lower than the footprintof the greater tuberosity at a 155° angle to the shaft axis preferably by using the mediumreverse body height template of 10mm.

The stem size is now determined to fit the medullary canal by moving the register with thebody in place. The size of the reverse body (36mm or 42mm) should be selected as largeas possible to the anatomy. For additional information, the rotation centers of the differentPE inserts are shown on the template.

There are also templates for the glenoid components for both glenosphere diameters showingthe centric and the eccentric version with the base plate and available screw lengths, toestimate adequate positioning of the base plate.

The definitive sizes of the reverse body, PE insert and centric or eccentric glenosphere aregenerally decided during the operation using trial components.

For a better imagination of the shape of the glenoid, a CT scan is recommended to get a betterunderstanding for setting the glenoid screws.

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Patient Positioning

The patient is placed in a semi-sitting (beachchair) position, inclined approximately 30° ormore. The patient should be positioned onthe operating table as far as possible to theside being operated on. The shoulder andarm should come to rest beyond the edge ofthe table in order that the arm can be freelyextended, adducted slightly, and subjectedto external rotation.

Especially in the case of obese patients, it isimportant to ensure good positioning withappropriate freedom of arm movement. Adequate exposure of the dislocated proximalhumerus without torsional or flexural forcesbeing exerted on the humerus by the edge ofthe table is essential for neat, safe implantationof shoulder prosthesis.

The sterile drape is placed so that the armcan be moved freely during the operation. Optionally, an arm holder can be used.

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Surgical Technique

Approach to the glenohumeral joint

A standardized deltopectoral approach is recommended. An anterolateral McKenzie techniquecan be used as an alternative. Both approaches call for anatomically accurate and stablereinsertion of the muscle-tendon units (subscapularis tendon and/or the deltoid muscle).The deltopectoral interval is opened medial to the cephalic vein to preserve venous dischargefrom the deltoid muscle. The anterior humeral circumflex vessels are exposed and ligated.The anatomical landmarks (rotator interval, bicipital groove, lesser and greater tuberosities)allow precise orientation in relation to the humeral head. The subscapularis tendon istransected 1cm medial of the insertion on the lesser tuberosity together with the articularcapsule and subsequently reinserted laterally, with a direct side-to-side, preferably transosseous suture of the tendon ends.

Alternatively, the subscapularis tendon can also be detached from the lesser tuberosity withan osteotome and reattached with transosseous sutures, wires, or with a screw. Lengtheningof the subscapularis is not needed if a complete release is performed. This step is crucialfor adequate postoperative range of motion.

We recommend circumferential mobilization of the subscapularis tendon. This is achieved by incision of the rotator interval including transection of the coracohumeral ligament at thebase of the coracoid. Then the capsule is sharply released from the anterior glenoid andadhesions are resected, including the more medial tendon muscle unit from the anteriorscapular neck. By means of this circumferential release, the tendon-muscle unit of the subscapularis muscle becomes functional again with normal excursion. This step is crucial for adequate postoperative range of motion.

A continuation of the capsulotomy with release of the capsular contractures, especiallyinferiorly, facilitates the subsequently necessary dislocation of the humeral head in orderto expose the humerus for humeral head preparation and anatomical resection. Attentionto the n. axillaris has to be payed by palpation or visualization the nerve will be protected.After humeral head resection, a capsulotomy is completed in a later step, the aim beingcircumferential arthrolysis.

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Resection of the humeral head

Exposure of the humeral head is performed with cautious external rotation while the arm is held in the adducted and extended position. First, this maneuver is only possible if thepatient is positioned correctly. The exposure is facilitated by the described release of capsular contractures by means of an extensive semicircumferential capsulotomy. As a result, complete external rotation is made possible with corresponding humeral head exposure without any flexural or torsional forces acting on the humeral stem. The patient’s hand should point towards the head of the OR table.

Cut off the tip of the humeral head approximately at the height of the recess to the anatomical neck with an oscillating saw to make an easier entry.

Fit the handle with the quick adapter ontothe awl.

Fit the sleeve of the cutting device ontothe awl.

Insert the awl turning left and right into thecenter of the medullary canal.

Press the pegs of the sleeve into the bone.

Remove the handle from the awl.

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The device is adjustable in:• height• anterior/posterior position• medial/lateral position• retrotorsion

Choose the reverse cutting adapter left or right, according to the required side you need to operate.

Screw the fixation screw M/L (blue) throughthe center of the oblong hole.

Hold the humeral cutting block (yellow) with the fixation screw M/L slightly loose, so that the block can be moved for the medial/lateral correct position.

Place the cutting adapter on the arm of thecutting device.

Pretighten the cutting device with the fixation screw A/P (orange) of the adapter within the slotted area.

Screw in the orientation pin with 0° to thearm on the cutting device or with 10° to thecutting adapter for the desired retrotorsion.

If the height adjustment screw (green) wasdisassembled for sterilization, preset thescrew in the middle of the threaded cylinder.

To perform an accurate cut, assemble the cutting device before placing it over the awl.

Fixation Screw A/P

Fixation Screw M/L

Reverse Cutting Adapter

Humeral Cutting Block

Reverse Cutting Device

Orientation pin

Height Adjustment Screw

0°

10°

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Place the cutting device on the awl with the sleeve.

Adjust the device with the orientation pincorresponding to the axis of the forearm.

The ideal retrotorsion of the resection isapproximately 10°. The pin set to 10° mustbe in line with the lower arm in 90° flexion.

The resection shall be performed slightly(1–2mm) lower than the footprint of thegreater tuberosity.

The resection is made at a fixed 155° angleand therefore less steep than the anatomicalcut of a PROMOS™ STANDARD which is usuallybetween 130° and 140°.

Place the cutting adapter to determine the resection line.

Adjust the adapter and the cutting block andsecure them in the position with the fixationscrews (orange, blue).

Adjust the height by turning the height adjustment screw (green). Clockwise rotationwill lift up the cutting block.

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Insert the pin to its adapter applied to yourpower tool.

Drill at least two pins through the cutting blockfor the fixation to the humerus. Make sure the drills don’t reach the awl in the cavity.

Release the fixation screw M/L (blue) fromthe cutting block completely.

Remove the cutting device together with theawl and sleeve.

Perform the resection freehand over thecutting block. You will get a resection angleof 155°.

Remove the cutting block and the pins withthe pin adapter.

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Place the trial body 36 or 42 upside down onthe resection area to decide the neededdiameter.

Choose the diameter as large as possible.

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Preparation of the glenoid and implantation of the glenoid component

After humeral head resection, the arm is returned to the neutral position. In order to exposethe glenoid, the humerus is retracted posteroinferiorly using a humeral head retractor whichis applied to the posterior glenoid neck, along the posterior osteophytes. In addition, sharpand blunt retractors are employed around the glenoid, usually with one anteriorly on thescapular neck and one inferiorly at the glenoid neck. The capsulotomy is completed dorsallyin order that the result is circumferential arthrolysis with complete soft-tissue release. This isthe only way to completely expose the glenoid, which is a prerequisite for clean implantationof the glenoid component.

Next, the glenoid is debrided down to the osseous glenoid by removing any remaining partsof the anterior lip osteophytes and any residual cartilage.

The prerequisite for accurate anatomical implantation of the glenoid component is identificationof the arthrosis-induced bony glenoid change in each specific case. Preoperatively theshape and version of the glenoid can be obtained from axial beam X-Ray images and a CTscan or MRI if necessary. Glenoid retroversion must be recognized in order to correct glenoidversion, if needed.

Position the guide wire

Remove the labrum around the glenoid rimand the cartilage.

The glenoid template size 1 is placed approximately 3mm below the optical center of the glenoid and slightly posterior.

The 3mm guide wire is passed through thecentral hole in the glenoid template (size 1).

Select the direction for the wire with the indexfinger on the ventral glenoid neck. The orientation of the wire can be anticipated in the direction of the scapular pillar for correct placement of the base plate.

After placing the guide wire, the glenoidtemplate is removed and the correct positionof the guide wire is checked again.

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Ream the glenoid fossa

Start the reaming with the smallest segmented reamer (Ø30mm). The reamer is applied over the guide wire and placed onto the glenoid.

The drive shaft is then brought over theguide wire and attached to the reamer.

In order to prevent glenoid fractures, thereaming should be started before applying axialforces to the drive shaft. If in doubt, handreaming is possible using the awl handle. Careis taken to preserve glenoid orientation.

Use the reamer carefully to avoid fracturing ofthe glenoid in sclerotic situations. In cuff teararthropathy situations the bone is usually softand the reamer has to be applied very carefullyto make sure that reaming is only performedinto the subchondral bone.

The glenoid fossa is reamed gradually startingwith the smallest size (Ø30mm), until the planned glenosphere head size (Ø36mm/42mm) is reached.

After the reaming of glenoid fossa is performed, remove the reamer, but do not remove the guide wire.

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Drill the central anchoring hole for theglenoid base plate

Guide the glenoid central reamer with theguide wire.

Attach the drive shaft to the reamer.

Drill until the stop on the reamer touches the bone.

CautionTo ensure proper implant anchorage it isimportant to drive the central reamer to the stop.

Remove the reamer and the guide wire.

Drill the peripheral holes for anchoring the glenoid base plate

The glenosphere drill guide is mounted on the drill guide holder so that the handle is ventral.

Position the glenosphere drill guide into thereamed central hole.

Select the position of the drill guide by rotatingthe vertical laser mark in the direction of thescapular pillar by palpating with the indexfinger to get the optimal bone screw in position.

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Drill the peripheral holes for the glenoid baseplate using the peripheral reamer.

Drill until the stop of the reamer touches thedrill guide holder.

Implantation of the glenoid base plate

Fit the glenoid base plate impactor to the base plate by means of the holding screw.

CautionEnsure correct position of the base plate. The wider body of the pear-shaped design is placed caudal.

Insert the glenoid base plate into the preparedglenoid until good bone contact is reached. If necessary, a gentle blow with the mallet can be applied.

Loosen the holding screw and remove theimpactor.

CautionEnsure that the back of the glenoid base plate has good bone contact.

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Implantation of glenoid bone screws

Screw the drill sleeve into the glenoid base plate.

Drill the holes for the glenoid bone screwsuntil it perforates the cortical bone.The depth markings on the drill can be directlyread and correspond to the available screwlengths of the glenoid bone screws.

Press the base plate down during drilling, notto loose the correct position.

Check again with the finger along the scapulapillar for the correct orientation of the drill.

Fit the screwdriver T25 into the quick couplingof the modular screwdriver.

Screw in the glenoid bone screws until they are fixed in the thread of the glenoid base plate.

CautionEnsure that the glenoid bone screws are fullyrecessed into the glenoid base plate and astable position is achieved. Do not overtighten.

Preparation of the distal humerus

Broach the humerus starting with the smallest rasp (02) using the rasp adapter in axis to thehumeral shaft and orthogonal to the resectedsurface (along the head center line).

Insert the rasp until there is good contactbetween the rasp and the diaphyseal cortex.The shallow-angled (155°) depth markings show the available height range (5, 10, 15) for the reverse body.

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NoteThe depth markings with the steeper angles are for the PROMOS™ STANDARD procedure.

The humerus is rasped step-by-step. Care must be taken to ensure that during impaction and removal of the rasp, no torsional or flexural forces act on the humerus. In particular, torsional forces due to holding of the arm must be avoided to minimize the risk of a humeral shaft fracture in patients with poor bone quality. The starting stem rasps should be introduced into the humerus over the third mark.

Insert the last stem rasp until there is good contact between the rasp and the diaphyseal cortex. The center mark corresponds to the middle height reverse body mounted on the corresponding stem. Introduction of the rasp to the upper or lower line can be compensated by using the larger or smaller reverse body.

A “half-size” stem (sizes: 0, 1.5, 2.5, 3.5) has to be considered if contact with the next size rasp cannot be reached to the first mark.

A half-size stem with small body approximately corresponds with the smaller stem with a tall body.

To check the humeral shaft preparation and to form a basis for the proximal humeral preparation, the appropriately sized trial stem is brought into the prepared medullary canal.

Connect the trial stem with the inserter and the T-handle and secure it with the holding screw.

The depth markings on the inserter show the three available sizes (5mm, 10mm and 15mm) of the reverse body.

NotesThe depth markings with a shallow angle show the height range for the reverse procedure. It is important to always check the depth with the trial stem first.

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Check the correct fit of the trial stem in the medullary canal and determine height for the reverse body.

NoteIf the inserter passes the third mark, the next size rasp has to be taken to prepare a correct implant seating.

Attach the appropriately sized humeral stem component to the inserter.

The stem is seated carefully with hammer blows until the implantation height determined with the trial stem, has been reached. The axial orientation previously determined using the rasp must be observed.

Then the inserter is carefully removed from the stem by loosening the holding screw.

NoteAfter placing the stem, if you end up between two depth markings, choose the taller bodyto avoid cortical contact before the stem andbody are connected.

You can proceed with the trial build-up with the trial stem, or the implant stem.

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Preparation of the proximal humerus

This step is only necessary in high bone density situations or revision surgery.

• Screw the stem extension into the humeral stem using the knob.

• Insert the hollow reamer into the handle with the quick adapter.

• Fit the hollow reamer onto the stem extension.

• Expose the cylindrical region of the reverse body using the hollow reamer.

• Unscrew the stem extension, using the knob and take it out.

Screw an orientation pin into the desired retroversion position into the reamer guide.

Insert the reamer guide, which corresponds to the selected height (5mm/10mm/15mm)

of the reverse body according to the indicated rasp and inserter marking, into the reamer guide fixation device and tighten the fixation screw.

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Mount the T25 insert bit into the quick couplingof the modular screwdriver.

Attach the reamer guide fixation device ontothe humeral stem.

Tighten the reamer guide onto the humeralstem in the selected retroversion with themodular screwdriver.

Remove the fixation device by releasing thefixation screw and then extracting the fixationdevice along the reaming axis.

Ream the proximal humerus with the humeralreamer that corresponds to the selected implantsize of the reverse body.

CautionThe humeral reamer has to be driven into thereamer guide to the stop position. This canalso be observed through the opening in thereamer shaft.

Mount the T25 insert bit into the quick couplingof the modular screwdriver.

Remove the reamer guide from the humeralstem by releasing the attachment screw.

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Trial reverse body

Fit the trial reverse body to the humeral stem.

Screw the orientation pin in the desired position into the orientation device, and place the orientation device into the body.

Adjust or check the retroversion with theorientation guide.

Attach the T25 insert bit into the quick coupling of the modular screwdriver.

Tighten the trial reverse body with the screwdriver.

Take the orientation device out.

Trial insert

Insert the 6mm trial insert into the reverse body according to the selected implant diameter.

Place the trial insert and carry out the stability/function test after the glenoid component isplaced.

If the stability of the shoulder is too lax or tootight, change the PE insert and carry out thetest again.

There are three heights of PE inserts 6mm, 9mm and 12mm available.

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Trial glenosphere

The glenosphere implants are available intwo diameters, 36mm and 42mm, and areeither centric or eccentric spheres.

Place the centric glenosphere trial andtest the range of motion (ROM).Depending on the scapular pillar shape, you may find an inferior impingement with the pillar(if you feel a lever out of the insert in full adduction to the body). In this case, place theeccentric trial head and repeat the ROM testing.

NoteIf you still feel impingement with the eccentric36mm combination, you can consider changingto 42mm. In this case, some cortical bonewill also be removed medially on the humerusbut this is not needed for the system basedon the stable distal stem anchorage.

Plug on the adapter glenosphere (centric oreccentric depending on the implants youwant to use, they work with both diameters)on the inserter glenosphere.

Screw in the trial fixation screw inserter andattach the trial glenosphere to a slight fit.

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Place the instrument into the glenoid base plate.

CautionEnsure that the trial glenosphere fits exclusivelyonto the cone of the glenoid base plate anddoes not touch the bone. Otherwise removeadditional bone to prevent impingement.

Introduce the modular screwdriver T25through the trial fixation screw inserter.

Tighten the trial glenosphere.

Take the screwdriver out.

Loosen the trial fixation screw inserter andremove all instruments.

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Align and carry out the stability/function test

Test the range of motion with all trials installed.

NoteIf the stability of the shoulder is too lax or too tight, change the PE insert and carry out the test again.

Remove all trials

Take out the trial glenosphere by loosening the fixation screw with the modular screwdriver or using the inserter glenosphere.

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Remove the trial insert with the trial insert extractor.

Release the attachment screw of the trial reverse body.

Extract the trial reverse body from the humerus.

If, in some cases, the trial body has a tight fit:• Insert the reverse body loosening adapter in the quick coupling of the trial reverse body.

• Hook the adapter of the extractor reverse in the loosening adapter and fix it with the adapter screw of the extractor.

• Screw the adapter to the slap hammer, connect it with the adapter screw and pull the trial out.

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Align and carry out the stability/function test

CautionBefore inserting the reverse body, the trialbed has to be verified using the trial reversebody. An accurate implant bed is essential toensure a good implant anchorage.

CautionThere must be no residual material (bone orsoft tissue) before implanting the parts especially on all connections.

Fit the reverse body onto the humeral stem.

Adjust or confirm the retroversion using theorientation guide.

The reverse body is pressed onto thedistal stem with the aid of the assembly clamp (1).

• Attach the mounting adapter (3) to the reverse body through the orientation guide.

• The two-part connection screw (2) is introduced into the assembly clamp.

• The assembly clamp is placed through the mounting adapter (3) on the body and the connection screw is tightened to the distal stem with the clamp handles wide open.

• Squeeze the clamp handles together. When this is done, the body is fixed to the stem without driving the stem deeper.

• The connection screw is tightened again and the clamp handles are pressed together. This process should be performed a total of three times. The force applied is sufficient to achieve a stable joint between the body and the stem.

• The clamp is now released and removed.

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Screw for the reverse body

Fit in the reverse body screw for the additionaltaper connection.

Fit the orientation guide into the reverse bodyin order to absorb the counter torque.

Tighten the screw for reverse body with thetorque screwdriver to the “Implants” marking.

CautionTo neutralize excessive torque forces to thehumeral stem when tightening the screw, fix the orientation guide with your free hand.

CautionThis screw is part of the mechanical connectionbetween the reverse body and the humeral stem and it is therefore essential that it is mounted.

Implant the PE insert

Check again for clean interior geometry of the reverse body.

Fit the PE insert into the reverse body.

CautionTurn the PE insert slightly before impacting toensure that it is not misaligned.

Impact the PE insert into the reverse body with light hammer blows.

CautionThe PE insert may only be fitted once.

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Implantation of the glenosphere

Assemble the glenosphere implant to thesetting instrument using the fixation screwinserter to fix the implant to the instrument.

Attach the glenosphere to the base plate andgive a slight push.

CautionEnsure that the glenosphere fits exclusively onto the cone of the glenoid base plate and not onto the bone. Remove some bone if needed.

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For the glenosphere fixation, there is a specialconnection screw for better handling of the mounting clamp. The two-part connectionscrew (see reverse body) can also be used.

• Fit the glenosphere mounting adapter (1) onto the connection screw (2).

• Screw the connection screw (2) through the glenosphere into the glenoid base plate.

• Fit the mounting clamp (3) over the connection screw in the mounting adapter.

• Fit the force transmitter (4) over the connection screw (2).

• Turn the connection screw (2) plane to the end of the force transmitter (4).

• The retainer head (5) can then be slotted in from the side over the connection screw. The connection screw (2) will be tightened.

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Implant screw for the glenosphere

Attach the T25 bit to the torque screwdriver.

Tighten the screw (packed together with theglenosphere) for the glenosphere with thetorque screwdriver to the “Implants” marking.

CautionThis screw is part of the mechanical connectionbetween the glenosphere and the baseplate and it is therefore essential that it ismounted to double-secure the connection.

Align and carry out the stability/function test.

Test the range of motion.

• The handles of the clamp (3) are pressed together. Now the connection screw (2) has to be tightened again. This should be performed a total of three times. The force applied is sufficient to achieve a stable joint between the body and the stem.

• Take the retainer head off, remove the mounting clamp and release the connection screw.

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Revision SurgerySpecial tips and instruments for revision surgery

Release the glenosphere from the glenoid base plate

Remove the glenosphere implant screw with the modular screwdriver and the T25 bit.

Sequence of assembly of the removal device Preassembly before surgery (orange): Place

spring (A) into lever (G). Then place the base disk (B) and secure with locking screw (C).

• Attach sleeve (E) to the top lever (F) with a one-quarter turn (90°), while simultaneously pressing the sleeve.

• Insert rod (D) into sleeve (E). (Screw it in, then the clamp is adapted to the loosening part to the stop).

RemarkWhen the releasing clamp is assembled, toplever (F) does not get into contact with bottomlever (G) due to its spring-forced load.

Disassembling the removal device

Remove rod (D).

Release sleeve (E) from the releasing clamp with a 90° turn while pressing the sleeve slightly at the same time.

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Set the screw for the loosening adapter into the glenoid base plate.

Screw the sleeve of the loosening adapter into the glenosphere.

Attach sleeve (E) to top lever (F) with a one-quarter turn (90°) while at the same time lightly pressing the sleeve.

Hook the releasing clamp onto the looseningadapter.

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Insert the threaded rod (D) into sleeve (E) andscrew it in until the stop.

Release the glenosphere from the glenoidbase plate by pressing the two levers together.

Disassemble the instrument.

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Release the reverse body from the stem

The polyethylene insert is removed by drilling a cutting-block pin or bone screw through the insert to the body.

Release the body screw using the modular screw driver with the orientation guide in order to absorb the counter torque.

Insert the reverse body loosening adapter in the quick coupling of the reverse body.

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Fit the releasing clamp onto the reverse bodyloosening adapter and hold it.

Insert the threaded rod (D) into sleeve (E) andscrew it in until the stop.

Release the body from the stem by pressingthe two levers together.

Disassemble the instruments.

Total explantation of the humeral sidecomponents

Connect the reverse body loosening adapterinto the quick coupling of the reverse body.

Engage the extraction adapter into theloosening adapter.

Screw the extraction screw into the adapter.

Connect the slap hammer with fitted adapterwith the extraction screw.

Pull the humeral implants out of the humeruswith the slap hammer.

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PROMOS™ System Revision from STANDARD to REVERSE

Determine which PROMOS STANDARD bodyand inclination set was primarily implanted(Figures. 1 and 2).The old type body is shown in Figure. 1, whoseinclination set is placed deeper into the body.

Determine the needed reverse implants bypreoperative planning with the templates.

The well-fixed stem will stay in situ (Figure. 3).

Removal of the head

Gently press the head removal tool betweenthe gap of the head and the resected surfaceof the humerus.

Apply a light hammer blow onto the head and the taper connection will loosen.

Removal of the inclination set

Unscrew the inclination set with the modularscrew driver by using the holding fork as acounter torque.

This works with the old as well as the current inclination set. If the older type inclination set is used, place the screwdriver SW 5.0mm. The actual screw takes the T25 bit.

Figure 1 Figure 2 Figure 3

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Removal of the standard body

Loosen the fixation screw of the standardbody. Use the modular screwdriver withthe T25 bit for the actual body and the SW3.5mm bit for the old type standard bodies.

Press the corresponding screw remover downinto the screw head and remove the fixationscrew.

Fit the assembled releasing clamp onto thestandard body and hold it.

Insert rod (D) into sleeve (E) and screw the threaded rod (D) into the implant until the stop.

Release the body from the stem by pressingthe two levers together.

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Explantation of the glenoid

Remove the glenoid component and remaining cement.

Preparation of the proximal humerus

Take the inserter to estimate the height of the needed reverse body on the indicatedreverse marking.

This step is only necessary in high bonedensity situations or revision surgery.

• Screw the stem extension into the humeral stem using the knob.

• Insert the hollow reamer into the handle with the quick adapter.

• Fit the hollow reamer onto the stem extension.

• Expose the cylindrical region of the reverse body using the hollow reamer.

• Unscrew the stem extension, using the knob, and take it out.

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Screw an orientation pin into the desiredretroversion position into the reamer guide.

Insert the reamer guide, which correspondsto the selected height (5mm/10mm/15mm) of the reverse body according to the indicated rasp and inserter marking, into the reamer guide fixation device and tighten the fixation screw.

Mount the T25 insert bit into the quickcoupling of the modular screwdriver.

Attach the reamer guide fixation device ontothe humeral stem.

Adjust the reamer guide to the desiredretroversion and tighten the screw with themodular screwdriver.

Remove the fixation device by releasing thefixation screw and then extracting the fixationdevice along the reaming axis.

Proceed with the reverse component implantation as described in this surgical technique.

If there is overlapping bone to the reverse body, cut it off free-hand.

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Sterilization

Implants

All the implants described in this surgical technique are supplied by the manufacturer in a sterile condition. Resterilization is not allowed.

The PROMOS shoulder implants are packaged in a carton and three pouches.1. The outer pouch is considered non-sterile and should be opened outside of the sterile field.

2. Peel open the outer pouch and retrieve all contents including the Chart-Stik™ labels.

3. The secondary pouch is considered a sterile barrier. Peel open the second pouch to present the contents.

Do not drop the Chart-Stik labels onto the sterile field.

4. Present the contents to the sterile field using aseptic presentation technique.

The product should not be dumped into the sterile field, but rather be transferred directly to the scrub nurse.

Instruments

The system instruments are non-sterile when delivered. Before use, they must be cleaned by the usual methods in accordance with hospital regulations and sterilized in an autoclave in accordance with the national legal regulations and recommendations. (For detailed information please refer to the leaflet Lit. No. 1363-e)

For correct settings, refer to the user instructions issued by the autoclave manufacturer. Instrument manufacturers and dealers do not accept any responsibility for the sterilization

of products by the customer.

41

Catalog Information – Implants

Humeral stem non-cemented

Cat. No. Cat. No. SAP Size42001 7500-6533 0142009 7500-6555 042002 7500-6537 142019 7500-6601 1.542003 7500-6538 242020 7500-6607 2.542004 7500-6539 342008 7500-6550 3.542005 7500-6541 442006* 7501-0867 5

Reverse body

Cat. No. Cat. No. SAP Size14000025 7500-3719 Ø 36/15mm14000026 7500-3720 Ø 36/10mm14000027 7500-3721 Ø 36/15mm14000019 7500-3713 Ø 42/15mm14000020 7500-3714 Ø 42/10mm14000021 7500-3715 Ø 42/15mm

PE-insert reverse

Cat. No. Cat. No. SAP Size14000006 7500-3702 Ø 36/16mm14000007 7500-3703 Ø 36/19mm14000008 7500-3704 Ø 36/12mm14000009 7500-3705 Ø 42/16mm14000010 7500-3706 Ø 42/19mm14000011 7500-3707 Ø 42/12mm

*Need to be ordered separately

Set No. 7520-0677

42

Catalog Information – Implants

Glenoid Base Plate

Cat. No. Cat. No. SAP14000018 7500-3712

Glenosphere centric

Cat. No. Cat. No. SAP Size14000014 7500-3710 Ø 3614000015 7500-3711 Ø 42

Glenosphere centric

Cat. No. Cat. No. SAP Size14000012 7500-3708 Ø 36/+514000013 7500-3709 Ø 42/+5

Glenoid Bone Screw

Cat. No. Cat. No. SAP Size14000001 7500-3697 Ø 6/20mm14000002 7500-3698 Ø 6/25mm14000003 7500-3699 Ø 6/30mm14000004 7500-3700 Ø 6/35mm14000005 7500-3701 Ø 6/40mm

Size 5 Stem (Cat. no. 7501-0867) can be ordered along with the Set no. 7520-6033.

Set No. 7520-6033

Cat. No. Part No. Description Qty7509-5301 24000183 Stem Rasp 5 1

7502-3820 24000178 Trial Humeral Stem 5 1

43

Set No. 7520-6030

Set No. 7520-6031

Catalog Information – Instrument Sets

44

Tray 1 General Glenoid TrayTray No. 7502-3136

Cat. No. Part No. Description Qty

7500-6565 420120 Glenoid Template Forceps 1

7500-6561 420116 Glenoid Template 1 1




7500-6583 420151 Drill Guide Holder 1

7501-8285 2400076 Kirschner Guide Wire 3mm

3


7500-6584 420152 Drill with Stop 5.5mm 1

7501-8286 24000077 Drive Shaft 1

7500-5281 24000057 Slotted Tube 1

7500-5275 24000051 Glenoid Reamer Segmented, 30mm

1


1


1


45

Tray 2 Cemented Glenoid TrayTray No. 7502-3137


7500-6497 420001 Trial Glenoid 1-23 17500-6525 420002 Trial Glenoid 1-26 17500-6526 420003 Trial Glenoid 1-29 17500-6527 420004 Trial Glenoid 2-23 17500-6528 420005 Trial Glenoid 2-26 17500-6529 420006 Trial Glenoid 2-29 17500-6631 420258 Trial Glenoid 2-32 17500-6530 420007 Trial Glenoid 3-23 17500-6531 420008 Trial Glenoid 3-26 17500-6532 420009 Trial Glenoid 3-29 17500-6632 420359 Trial Glenoid 3-32 17500-6534 420010 Trial Glenoid 4-23 17500-6535 420011 Trial Glenoid 4-26 17500-6536 420012 Trial Glenoid 4-29 17500-6633 420260 Trial Glenoid 4-32 1


7500-6620 420243 Glenoid Impactor 17500-6618 420241 Centering Peg Inserter 17500-6586 420154 Trial Glenoid Extractor 17500-6558 420110 Centering Peg 5.5mm 27500-6559 420111 Centering Peg 6.5mm 17500-6579 420147 Glenoid Drill Guide 1 17500-6580 420148 Glenoid Drill Guide 2 17500-6581 420149 Glenoid Drill Guide 3 17500-6582 420150 Glenoid Drill Guide 4 17500-5286 24000063 Cannulated Drill 6.5/3mm 17500-6554 420083 Drill with Stop 5.5mm 17500-3282 130490 Flexible Shaft with Quick

Couple1

7500-6567 420122 Glenoid Holder 17500-6577 420144 Glenoid Holding Block 1

46

Tray 3 General Humeral TrayTray No. 7502-3138


7500-6570 420128 Rasp Adapter 27500-6578 420145 Spacer 1.3 17500-6553 420082 Awl Handle 17500-6556 420098 Awl 17500-6673 420322 Stem Rasp 01 17500-6672 420321 Stem Rasp 02 17500-6674 420323 Stem Rasp 1 17500-6675 420324 Stem Rasp 2 17500-6676 420325 Stem Rasp 3 17500-6677 420326 Stem Rasp 4 17509-5301 24000183 Stem Rasp 5* 1


7500-6604 420193 Trial Humeral Stem 0 17500-6587 420156 Trial Humeral Stem 01 17500-6588 420157 Trial Humeral Stem 1 17500-6605 420194 Trial Humeral Stem 1.5 17500-6589 420158 Trial Humeral Stem 2 17500-6606 420195 Trial Humeral Stem 2.5 17500-6590 420159 Trial Humeral Stem 3 17500-6602 420191 Trial Humeral Stem 3.5 17500-6591 420160 Trial Humeral Stem 4 17502-3820 24000178 Trial Humeral Stem 5* 1

Tray 4 General Humeral Tray 2Tray No. 7502-3139

Cat. No. Part No. Description Qty7500-6593 420175 Connection Screw (2 Parts) 17500-6599 420188 Connection Screw Set 17500-6609 420205 Mounting Clamp 17500-6666 420316 Inserter 0+01 17500-6667 420317 Inserter 1+1.5 17500-6668 420318 Inserter 2+2.5 17500-6669 420319 Inserter 3+3.5 1


7500-6671 420320 Inserter 4 17500-6572 420133 Holding Screw 17500-6571 420132 T-Handle 17500-6679 420328 Modular Screw Driver 17500-6643 420271 Screw Driver Stepped T25 27500-6610 420209 Torque Screwdriver 3/6NM 1

*available as part of Set no. 7520-6033


47

Tray 5 Humeral Trials TrayTray No. 7502-1529

Cat. No. Part No. Description Qty7500-6644 420272 Body Adapter 30mm 17500-6645 420273 Body Adapter 35mm 17500-6646 420274 Body Adapter 40mm 17500-6624 420251 Trial Body 30mm 17500-6625 420252 Trial Body 35mm 17500-6626 420253 Trial Body 40mm 17500-6640 420268 Trial Monoblock Stem 02/3 17500-6641 420269 Trial Monoblock Stem 02/3 17500-6642 420270 Trial Monoblock Stem 02/4 17510-1980 75101980 Primary Alignment Disc 1

Cat. No. Part No. Description Qty7510-1981 75101981 Sleeve Alignment Disc 17500-6627 420254 Trial Inclination Set 20mm 17500-6628 420255 Trial Inclination Set 22mm 17500-6629 420256 Trial Inclination Set 24mm 17500-6630 420257 Trial Inclination Set 26mm 17500-2977 1214207 Resection Stylus 17500-6603 420192 Impactor for Monoblock 17510-1982 75101982 Holding Fork 17500-6680 420329 Backtable Holding Block 17502-3728 24000163 Screw Remover T257502-3729 24000164 Screw Remover Old Std Body SW3.5

48

Tray 6 Proximal StandardTray No. 7502-3141

Cat. No. Part No. Description Qty7510-1983 75101983 Sleeve/Head Impactor 17500-6634 420262 Trial HD R21/+4 17500-6635 420263 Trial HD R22/+4 17500-6636 420264 Trial HD R23/+4 17500-6637 420265 Trial HD R24/+4 17500-6638 420266 Trial HD R25/+4 17500-6639 420267 Trial HD R26/+4 17500-6654 420305 Trial HD R27/+4 17500-6655 420306 Trial HD R28/+4 17500-6542 420060 Trial HD R19/+2 1

Cat. No. Part No. Description Qty7500-6543 420061 Trial HD R20/+4 17500-6544 420062 Trial HD R21/+5 17500-6545 420063 Trial HD R22/+6 17500-6546 420064 Trial HD R23/+7 17500-6547 420065 Trial HD R24/+7 17500-6548 420066 Trial HD R25/+7 17500-6549 420067 Trial HD R26/+7 17500-6622 420248 Trial HD R27/+7 17500-6623 420249 Trial HD R28/+7 17500-6615 420214 Compatibility Chart 1

Tray 7 Revision TrayTray No. 7502-3142

Cat. No. Part No. Description Qty7500-7142 600181 Slap Hammer 17500-6611 420210 Screwdriver Bit SW 3.5 17500-6612 420211 Screwdriver Bit SW 5.0 17502-3134 24000158 G.S. Release Adapter 17502-3373 24000160 G.S. Screw Loosening

Adapter1

Cat. No. Part No. Description Qty7502-3135 24000159 Release Clamp (3-part) 17500-6621 420247 Slap Hammer Adapter 17500-6617 420240 Stem Extractor 17500-6647 420275 Extractor 17500-5283 24000059 Extractor Reverse 17500-6557 420109 Humeral Head Remover 1


49

Tray 8 Stem ReverseTray No. 7502-3572

Cat. No. Part No. Description Qty7500-5272 24000048 Reverse Humeral

Reamer ø361

7500-5273 24000049 Reverse Humeral Reamer ø42

1

7500-5259 24000033 Trial Reverse Body 36/5mm 17500-5260 24000034 Trial Reverse Body 36/10mm 17500-5261 24000035 Trial Reverse Body 36/15mm 17500-5262 24000036 Trial Reverse Body 42/5mm 17500-5263 24000037 Trial Reverse Body 42/10mm 17500-5264 24000038 Trial Reverse Body 42/15mm 17500-5238 24000012 Trial Insert 36/6mm 17500-5239 24000013 Trial Insert 36/9mm 17500-5240 24000014 Trial Insert 36/12mm 17500-5241 24000015 Trial Insert 42/6mm 17500-5242 24000016 Trial Insert 42/9mm 17500-5243 24000017 Trial Insert 42/12mm 1

7501-8925 24000151 Reverse Orientation Device ø36

1

7501-8926 24000152 Reverse Orientation Device ø42

1

7500-5266 24000040 Rev. Body Loosening Adaptor ø36

1

Cat. No. Part No. Description Qty7500-5267 24000041 Rev. Body Loosening

Adaptor ø421

7500-5284 24000061 Trial Insert Extractor 17500-5265 24000039 Reverse Body

Mounting Adaptor1

7500-5257 24000031 Stem Extension 17500-5253 24000027 Humeral Cut Block 17501-8917 24000143 Reverse Cutting Device 17501-8924 24000150 Rev. Reamer Guide

Fixation Device1

7500-5235 24000009 Reamer Guide 5mm 17500-5236 24000010 Reamer Guide 10mm 17500-5237 24000011 Reamer Guide 15mm 17500-5228 24000002 Reverse Hollow Reamer 17501-8916 24000142 Reverse Cutting

Adaptor Right1

7501-8915 24000151 Reverse Cutting Adaptor Left 17501-8918 24000144 Orientation Pins 37500-5256 24000030 Cut Block Pins 47500-5252 24000026 Sleeve to Cutting Device 17500-5278 24000054 Adapter Cut Block Pins 2

Supplemental Reverse Instrument SetSet no. 7520-6031

50

Tray 9 Glenoid ReverseTray No. 7502-3571

Cat. No. Part No. Description Qty7500-5282 24000058 Glenoid Baseplate

Impactor1

7501-8288 24000079 Drill Sleeve Ø4mm 2

7510-0384 24000203 Drill Ø4mm 27501-8922 24000148 Trial Glenosphere Centric 17501-8923 24000149 Trial Glenosphere Centric 17501-8912 24000138 Trial Glenosphere Eccentric 17501-8913 24000139 Trial Glenosphere Eccentric 17500-5270 24000046 Glenosphere Mounting

Adaptor1

7501-8911 24000137 Glenosphere Drill Guide 1

7500-5267 24000041 Rev. Body Loosening Adapter ø42

1

Cat. No. Part No. Description Qty7501-8909 24000135 Centric Glenosphere

Adaptor1

7501-8910 24000136 Eccentric Glenosphere Adaptor

1

7500-5245 24000019 Glenoid Central Reamer 1

7501-8914 24000140 Glenoid Peripheral Reamer 1

7501-8927 24000153 Trail Fixation Screw Inserter 1

7501-8908 24000134 Fixation Screw Inserter 1

7501-8907 24000193 Inserter Glenosphere 1

7500-5268 24000042 Impactor PE Insert 36mm 1

7500-5269 24000043 Impactor PE Insert 42mm 1


Smith & Nephew, Inc.7135 Goodlett Farms ParkwayCordova, TN 38016USA

Manufacturer Smith & Nephew Orthopaedics AG Oberneuhofstrasse 10d 6340 Baar Switzerland

Telephone: 1-901-396-2121Information: 1-800-821-5700Orders/inquiries: 1-800-238-7538

www.smith-nephew.com

™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged ©2013 Smith & Nephew. All rights reserved. 00763 V1 11/13

surgical technique - smith & nephe...1710: promos™ reverse humeral components 1711: promos...

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