for hemi bi-polar and total shoulder ......22.2mm bi-polar heads are available in std., +2mm and...

S H O U L D E R S Y S T E M

iFOR HEMI BI-POLAR AND

TOTAL SHOULDER ARTHROPLASTY

Anterior, posterior and lateralholes permit suture placementfor reconstruction of complexproximal humeral fractures

Proximal plasma sprayporous coating enhancesimmediate fixation

Proximal finsmaximizerotationalstability

Medial hole allows accurateversion control duringplacement of the stem

Secure RingLoc®

polyethylenelocking ring design

Distal cylindrical stem withsmooth blast finish to betterfill the humeral canal

The Bi-Polar humeral head is marketed for use inprimary cases of noninflammatory degenerative jointdisease, rheumatoid arthritis, correction of severefunctional deformity and fracture. The device isintended for use with a humeral stem inserted withbone cement. (USA)

22.2mm Bi-Polar heads areavailable in Std., +2mmand +4mm neck lengths

Bi-Polar cobalt chromeshells are available in 40,44, 48 and 52mm diameters

WARNING: Porous coated componentsdepicted in this brochure are marketed foruse with bone cement in the United States.

This system has been developed incooperation with Richard L. Worland, M.D.,Medical Director, The Joint ReplacementCenter, Advanced Orthopaedic Centers,Richmond, Virginia.

1Data on file at Biomet, Inc.

Bi- AngularBi-Polar SystemFeatures◆ Multiple component

combinations for optimalpatient sizing

◆ Primary and revision lengthporous titanium stems

◆ Non-porous cobalt chrome stems

◆ Variety of Bi-Polar shelldiameters and neck lengths

◆ Standard heads and glenoidsfor total shoulder replacement

Bi-PolarDesignStability1

◆ Axial separation strengthof over 170 lbs

◆ Cantilever separationstrength of over 45 in-lbs1

Bi-PolarIndications◆ Rotator cuff arthropathy

◆ Rheumatoid arthritis

◆ Four-part fractures inyoung patients

◆ Deficient glenoid bone stock

◆ Revision arthroplasty

◆ Avascular necrosis

◆ Some osteoarthritis

◆ Lateral offset facilitatestensioning of deltoid inrotator cuff deficient cases

◆ Rasps and broaches notrequired

◆ Tapered stems ensureaccurate fit in humeral bone

◆ Cylindrical distal stems tobetter fill the humeral canal

Bi-Angular®

Features &BenefitsSTEMS

◆ Concentric contact withshoulder cavity, bothsubacromial and glenoid

◆ Potentially less glenoid-acromial wear due tobi-rotational head/shell motion

◆ Enhanced tensioning ofdeltoid lever arm in rotatorcuff deficient shoulders

Bi-PolarFeatures&Benefits

Bi-Angular®

Features &BenefitsGLENOIDS

◆ All polyethylene or metal backed design options

◆ Metal backed glenoid hasporous coated pegs forenhanced fixation

◆ Glenoid instruments andimplants are designed for amore anterior approach,allowing easier exposure andimplantation

ADVANTAGES OFNON-COLLARED STEMS◆ Initial neck resection not critical

◆ No Bi-Polar shell impingement

◆ Ease of revision (stem removal)

◆ No subsidence reported in up to nine years follow-up on the Bi-Angular stem2

2Data on file at Biomet, Inc.

HEADS

◆ Cobalt chrome heads provideexcellent wear characteristics

◆ Three neck lengths optimizetissue tensioning

PREOPERATIVEThe patient is a 79-year-old femalewith a 12-year history of bilateralshoulder pain. She was unresponsiveto injections and anti-inflammatorymedications. The preoperativeSwanson Shoulder Score was 13.2/30.Her forward flexion was 40o andexternal rotation was 0o.

POSTOPERATIVEA Bi-Polar Head with an 11mmBi-Angular stem and 40mm shellwas used. Six weeks postoperative,her shoulder score had improvedto 30/30 with 150o of forward flexionand 30o of external rotation.

PREOPERATIVEThe patient is a 68-year-old femalewith osteoarthritis. Forward flexionwas 85˚, with a 10˚ internal rotationcontracture resulting in -10˚ ofexternal rotation. Internal rotationwas present to the left hip pocket.

POSTOPERATIVEFour years postoperative the patienthas 150˚ of forward elevation,85˚ external rotation, abduction to120˚ and internal rotation to L4.The patient has no sign of glenoidloosening.

Bi-Angular TotalShoulder Replacement

Bi-Polar HemiShoulder Replacement

◆

◆ PREFACEShoulder joint replacement is widely performed and the expected resultscan be compared to hip and knee joint replacement. The operation canbe difficult and should be performed by skilled shoulder surgeons whohave considerable experience in total joint arthroplasty. Glenoid replace-ment has and continues to be the most problematic area in glenohumeralreplacement. To address this concern, the Bi-Angular/Bi-Polar Shoulderwas developed, making shoulder arthroplasty a relatively easy procedureto accomplish with potentially few complications and predictable patientoutcomes. Patient selection is important since postoperative therapy iscritical, and the surgeon, therapist and patient must work closely togetherto ensure a good result.

The humeral component should always be cemented especially if theprosthesis is used for a four-part fracture in elderly patients. Standardcanal preparation should be performed, and the cement inserted with agun. However, firm pressurization must be avoided to prevent cementfrom being forced out the nutrient foramina. Care should be taken not toallow the cement to pass too distal should the possibility of future totalelbow arthroplasty exist. To ensure successful hemi-replacement forproximal humeral fractures, it is crucial that the tuberosities be sutured toeach other and to the humeral shaft. The humeral fins provide rotationalcontrol and are perforated to allow passage of sutures for tuberosityreattachment. Non-absorbable sutures should be passed through drillholes in the humeral shaft prior to placement of the cement and prosthesis.

The Bi-Angular/Bi-Polar Shoulder System offers the advantage of easy andaccurate component implantation. Six primary titanium stem sizes andthree revision titanium stems, coupled with three neck lengths and fourBi-Polar shell diameters, permit a wide range of modularity to achieveaccurate soft tissue tensioning. The bi-rotational head enhances implantstability and provides good fill of the entire shoulder space, both glenoidand subacromial.

The humeral stem design provides complete canal fill, and a medialthrough-hole accommodates a guide pin to permit accurate versioncontrol during stem placement. Proximal plasma spray porous coating onthe titanium humeral components provides enhanced componentfixation. Three nonporous cobalt chrome stem sizes are also available.Should glenoid replacement be elected, all polyethylene and metal-backed porous coated glenoid implants are available.

The modular design of the Bi-Angular/Bi-Polar Shoulder minimizesimplant inventory and allows for a better anatomic fit. The stem is easilyand accurately inserted after humeral canal preparation. This systemdoes not require rasps to finalize the version of the humeral component.Concerns with glenoid loosening, screws, glenoid preparation andinsertion, and glenoid fixation are avoided when the Bi-Polar head is used.

The surgical technique will vary somewhat depending on the individualclinical situation. The following technique description is intended solelyas a general guide for shoulder joint replacement with the Bi-Angular/Bi-Polar Shoulder System.

SurgicalTechnique

NOTE: This brochure describes thesurgical technique used by Richard L.Worland, M.D. Biomet, as the manufac-turer of this device, does not practicemedicine and does not recommend thisor any other surgical technique for useon a specific patient. The surgeon whoperforms any implant procedure isresponsible for determining and usingthe appropriate techniques forimplanting the prosthesis in eachindividual patient. Biomet is notresponsible for selection of theappropriate surgical technique to beused for an individual patient.

◆

◆

◆ Administer general endotracheal or interscalene block anesthesia. Placethe patient in the modified beach-chair position, lateralized on the tablewith a padded arm board to secure the patient’s head. Use a folded towelto support the ipsilateral scapula. A shoulder chair is an excellent alterna-tive, allowing good access about the shoulder should a posterior incisionbe required. The arm should be draped free.

Make the skin incision from the distal third of the clavicle, directed overthe coracoid and ending over the deltoid insertion on the humerus.Bluntly develop the deltopectoral interval, sparing the cephalic vein.Retract the deltoid laterally with the cephalic vein without detaching anyof its fibers proximally or distally, and divide the fascia longitudinallylateral to the coracoid.

Taking care to protect the musculocutaneous nerve, retract the shorthead of the biceps and coracobrachialis medially with a blunt retractorand place the arm into external rotation. To facilitate mobilization of thehumerus, divide the upper portion of the pectoralis major insertion byelectrocautery and identify the biceps tendon and subscapularis.

Divide the subscapularis 1cm medial to its insertion and tag it with anonabsorbable suture for later repair. Cauterize the anterior humeralcircumflex vessels and dissect the subscapularis back medial to theanterior glenoid rim.

Biceps Tendon

SubscapularisTendon

PATIENT PREPARATION

SURGICAL APPROACH

Pectoralis Major

Step 3

Step 2

Step 1

◆

◆ Divide the capsule superiorly, being careful not to divide the long headof the biceps. Place the arm into further external rotation and positiona Joker or Hohmann-type retractor below the capsule to protect theaxillary nerve. Incise the anterior and inferior capsule from the six to thetwelve o’clock position. Continue humeral external rotation and exten-sion to dislocate the humeral head anteriorly so that osteophytes can beremoved. Use a broad osteotome to remove the desired amount ofhumeral head, including all the articular surface, taking care not todamage the rotator cuff. Final trimming of the proximal humerus maybe performed with a rongeur after the humeral stem is seated in thehumeral canal. Provided the Bi-Polar shell does not impinge on theresected humeral bone, the exact angle of the neck cut is not critical.

HUMERAL OSTEOTOMY

Identify the medullary canal with a small curette. Ream by hand, startingwith the 6.5mm reamer and continuing sequentially until resistance fromcortical bone is encountered (cortical chatter). Six diameters are availableto appropriately match the individual patient anatomy.

Attach the humeral inserter handle to the selected humeral stem. Care-fully drive the component down into the humeral canal. Next, place a7/64" K-wire into the version hole in the stem to determine the retrover-sion of the humeral component, referencing off the patient’s forearm(usually 30-35˚).

If the stem is too tight, extract the prosthesis and use a curette to enlargethe proximal portion of the humerus. Then drive the prosthesis into placeunder direct vision, watching the three fins of the humeral component asthey cut into the soft bone of the proximal humerus. A stem one sizesmaller than the last reamer should be chosen to allow room for anadequate cement mantle. Once the prosthesis is properly seated, removethe humeral inserter and trim the proximal humerus with a small rongeur.

For Bi-Polar hemi arthroplasty, continue to Step 6.For total shoulder arthroplasty, go to Step 7.

HUMERAL SELECTION AND IMPLANTATION

K wire

Step 4

Step 5

◆

Bi-Polar Head

Position the trial head and shell components on the stem to determinethe proper neck length and shell size. The top of the head must projectabove the greater tuberosity to prevent tuberosity-acromial impinge-ment. Adequate soft tissue tension must also be restored. However, thecomponent should not set too proud or range of motion may bedecreased, resulting in less than optimal contact between the Bi-Polarshell and the true glenoid.

BI-POLAR HEAD ASSEMBLY:

1. Insert the metal locking ring into the groove in the Bi-Polar shell.(This is usually pre-assembled.)

2. Place the polyethylene locking ring over the stem trunion and impactthe 22.2mm head.

3. Place the outer shell with polyethylene liner over the 22.2mm head.4. Snap the polyethylene locking ring into the Bi-Polar shell.5. Should the prosthesis ever need to be removed, use the locking ring

removal tool to disassemble the Bi-Polar components, and the removalramp to disengage the modular head. Then attach the slap-hammerextractor to the humeral stem to remove it.

BI-POLAR HEMI ARTHROPLASTYStep 6

Bi-Polar Removal Tool

Metal Ring

22mm Head

Polyethylene Locking Ring

Outer Shell

Reattach the subscapularis with non-absorbable sutures. Then externallyrotate the arm to see at what degree of external rotation the suture linecomes under tension. This will be the maximum amount of externalrotation permitted during the first six weeks following surgery.

Close in a routine manner and apply a sling at the conclusion of theprocedure.

◆

◆ Position the trial modular head components on the stem to determinethe proper head height. The top of the head must project above thegreater tuberosity to prevent tuberosity-acromial impingement.Adequate soft tissue tension must also be restored. Seat the selectedtrial head on the Morse taper of the humeral stem and reduce theshoulder. Once the correct head size has been chosen, dislocate theshoulder and remove the trial head.

TOTAL SHOULDER ARTHROPLASTY

Glenoid Drill

DrillGuide

Abduct the arm to relax the deltoid, then retract the humerus posteriorlywith a Fukuda-type retractor placed behind the glenoid. Further capsularrelease may be required. Inspect the glenoid to determine whether itneeds resurfacing. Glenoid resurfacing may be indicated in osteoarthriticpatients with good bone stock and a functioning rotator cuff.

Replacement of the glenoid is carried out by first excising the glenoidlabrum and then debriding the surface of any cartilage and soft tissueremnants. Position the glenoid drill template with its keel resting on theanterior glenoid rim. Should exposure still be difficult, a portion of theconjoint tendon and coracoacromial ligament may be released.

If the all polyethylene glenoid is selected, simply develop the slot for thepolyethylene fin.

If the metal backed glenoid is chosen, use the glenoid drill with depthstop to make pilot holes for the two posterior glenoid pegs. Leave thefirst glenoid drill bit with depth stop in the bone for stability while thesecond hole is being drilled. Then create a slot for the polyethylene fin.

GLENOID PREPARATION

Trial HeadSeated

Step 7

Step 8

◆

◆

Fin Slot

Remove the drill guide and develop the fin slot with a burr and smallcurette. Use the glenoid broach to ensure that the trial glenoid can befully seated. Take care not to penetrate the glenoid posteriorly. If theglenoid does not seat fully, the polyethylene fin of the actual glenoidcomponent can be trimmed with bone scissors to allow full glenoidseating. (Avoid cutting the X-ray wire on the all polyethylene glenoidwhen trimming the component.)

Use a small drill bit to perforate the subchondral cortical bone of theglenoid surface in several places to permit additional cement fixation.Thoroughly cleanse the bone with pulsatile lavage and then dry itprior to applying the cement.

GlenoidComponent

GLENOID PLACEMENTPlace a small amount of cement in the slot for the fin of the glenoidcomponent. Fit the inserter into the glenoid component and place itinto position. Remove all excess cement. Using firm pressure, impact thecomponent into place and hold it until the cement has polymerized.

Seat the selected modular head component on the Morse taper of thehumeral stem with multiple light hammer strikes, and then reduce theshoulder. Should the humeral component ever need to be extracted,remove the head from the humeral stem with the removal ramp, andattach the slap-hammer extractor to the humeral stem to remove it.

HUMERAL HEAD PLACEMENT

◆

Step10

Step11

Step 9

◆

CLOSUREClose in a routine manner using non-absorbable sutures to repair thesubscapularis. Should lengthening of the tendon be necessary, sew thesubscapularis back to the humerus through drill holes at the osteotomysite of the head fragment. Close the subcutaneous tissues with absorb-able sutures, then close the skin with staples. It is not necessary to use adrain. Apply a sling at the conclusion of the procedure.

Postoperative care is as important as correct implant placement. Thesurgeon, therapist and patient must work closely together on the rehabili-tation program as defined by the surgeon based on the intraoperativerange of motion achieved.

Permit the patient free swing of the arm out of the sling the first postop-erative day, depending on discomfort. On the second day, passive andactive assisted external rotation and forward flexion exercises should beinitiated. Begin pulley exercises on the third day. Keep the patient in thehospital until at least 120˚ of active-assisted forward elevation has beenattained. This usually requires a total of three or four days in the hospital.Continue exercises on an out-patient basis, usually at home, until recov-ery is complete.

It is first necessary to achieve range of motion, and later strength can beincreased with purposeful use of the arm. Provide rubber tubing and apulley to the patient upon discharge from the hospital, and instruct thepatient to perform exercise sessions five times each day. A moist warmtowel applied to the shoulder prior to exercise sessions will help relax themuscles and encourage circulation. Follow the patient’s progress closely tosee whether further professional physical therapy is indicated. The ultimategoal for shoulder joint replacement is near normal shoulder function.

Should a prosthesis be used to treat a proximal fracture, initiate passiveexercises early if tuberosity fixation is secure. However, the patientshould use a sling for six weeks or as long as it takes for tuberosity unionto occur. At that point, initiate active-assisted exercises as described above.

◆Step12

Post-opCare

Titanium Humeral Stems (Porous Coated)

6.5 x 1158.0 x 1159.5 x 11511.0 x 11512.5 x 11514.0 x 115

Part No. Dia./Length (mm)

Bi-Angular/Bi-Polar Shoulder SystemOrdering Information

114071114072114073

Titanium Revision Humeral Stems (Porous Coated)

8.0 x 2059.5 x 20511.0 x 205


113130113131113132113133

Bi-Polar Shell Components

40 x 22.244 x 22.248 x 22.252 x 22.2

Part No.* O.D./I.D. (mm)

*(Includes metal locking ring, poly liner, poly ring, and metal shell)

114090114092114094

CoCr Humeral Stems (Nonporous)

6.5 x 1159.5 x 11512.5 x 115


114022114052114053114054114024114026

Humeral Heads

15 x 4015 x 4419 x 4423 x 4419 x 4823 x 52

Part No. Dia./Neck Length (mm)

114060114061

Glenoids

Standard Metal BackedStandard All Polyethylene

Part No.

114065114068114066114069114067114070

IMPLANTS

◆

113143113144113145

Bio-Modular®/Bi-Polar Modular Heads(Reverse Morse Taper)

22.2 / Standard22.2 / + 222.2 / + 4


113101113141113142

Bi-Angular®/Bi-Polar Modular Heads(Standard Morse Taper)

22.2 / Standard22.2 / + 222.2 / + 4


◆

Bi-Angular®, Bio-Modular® and RingLoc® are registered trademarks of Biomet.U.S. Patent Numbers 4,986,833 and 4,865,605.

INSTRUMENTATION

Humeral Stem TrialsDia./Length (mm)

414443 6.5 x 115414446 8.0 x 115414444 9.5 x 115414448 11.0 x 115414445 12.5 x 115414450 14.0 x 115

Humeral Head TrialsNeck Length/Dia. (mm)

414422 15 x 40414415 15 x 44414419 19 x 44414423 23 x 44414424 19 x 48414426 23 x 52

Glenoid Trials414430 Std. Metal Backed414436 Std. All Polyethylene

Bi-Polar Shell TrialsO.D./I.D. (mm)

408400 40 x 22.2408402 44 x 22.2408404 48 x 22.2408406 52 x 22.2

Bi-Angular/Bi-PolarModular Head Trials

Dia./Neck Length (mm)

408408 22.2 / Standard408410 22.2 / + 2408412 22.2 / + 4

Bio-Modular/Bi-PolarModular Head Trials

Dia./Neck Length (mm)408418 22.2 / Standard408420 22.2 / + 2408422 22.2 / + 4

Humeral ReamersDia. (mm)

414437 6.5414440 8.0414438 9.5414441 11.0414439 12.5414442 14.0

Bi-Polar Locking RingRemoval Tools

Dia. (mm)

408435 40408436 44408437 48408438 52

Other Humeral Instruments31-473620 Tapered Reamer

T-Handle31-473600 Hammer Plate

with Screw31-473601 Humeral Trial

Inserter/Extractor31-473621 Slide Hammer406514 Humeral Head

Driver408432 Humeral Head

Removal Ramp414447 Bi-Angular Shoulder

X-Ray Templates414449 Bi-Angular/Bi-Polar

Shell Templates406490 Bio-Modular/Bi-Polar

Shell Templates

Glenoid Instruments414429 Rasp414433 Drill Guide414434 Drill with Stop414431 Inserter414432 Pusher

for hemi bi-polar and total shoulder ......22.2mm bi-polar heads are available in std., +2mm and...

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