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Mathys balanSys REV, Surgical Techniques

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Mathys balanSys REV Surgical Techniques Download Page 80

80

 – balanSys REV – Extension Gap First: 3in1

Item no.

Description

Qty

71.02.3014

balanSys  impaction / extraction  rod

1

Item no.

Description

Qty

314.270

Screwdriver, hex., 3.5

1

Item no.

Description

Qty

315.310

AO Drill bit 3.2

1

Item no.

Description

Qty

71.02.3043

balanSys  Trs. handle  f / intramedullary  rod

1

Item no.

Description

Qty

71.02.3042

balanSys Trs. intramedullary rod

1

Item no.

Description

Qty

71.02.3054

balanSys  pin  3.2 / 80

10

Item no.

Description

Qty

77.02.0031

balanSys reference plate 1.3

2

Item no.

Description

Qty

71.02.3032

balanSys Trs. aiming device proximal

1

Item no.

Description

Qty

71.02.3034

balanSys Trs. aiming device distal

1

Item no.

Description

Qty

71.02.3035

balanSys Trs. ankle holder

1

Item no.

Description

Qty

71.02.3036

balanSys Trs. distal connector

1

Item no.

Description

Qty

71.02.3041

balanSys Trs. intramedullary shackle

1

Summary of Contents for balanSys REV

Page 1: ...technique balanSys REV Extension Gap First 3in1 For healthcare professional use only The illustrated image does not represent a connection between the use of the medical device described nor its perf...

Page 2: ...Mathys is committed to this guiding principle and pursues a product portfolio with the goal of further developing traditional philosophies with respect to materials or design in order to address exis...

Page 3: ...bly 51 Implantation 55 Appendix 58 1 Size compatibility of the balanSys REV Implants 59 2 Optional combination with balanSys BICONDYLAR 60 3 Item numbers of the balanSys REV Implants 62 4 Packaging of...

Page 4: ...to balanSys PS CR UC Inlays for complex primary TKA 5 sizes 64 70 75 80 85 Variability balanSys REV Stem Identical stems for tibia and femur With morse taper connection Straight and 4mm offset 12 dia...

Page 5: ...ment nerve or vessel insufficiency which may create an unacceptable risk of prosthesis instability prosthesis fixation failure and or complications in post operative care Compromised bone stock due to...

Page 6: ...ate BICON DYLAR Femur Furthermore the REV femur implants can be used in combination with a BICONDYLAR PS inlay Refer to appendix 2 for a detailed description of combina tion possibilities Additional i...

Page 7: ...ther intramedullary alignment can be performed If bone defects exist preoperatively the surgeon performing the procedure must understand the implications of this bone loss as well as the tech niques r...

Page 8: ...previous incisions stiffness or a fibrotic soft tissue envelope Usually greater exposure is required for a revision total knee arthroplasty as compared with that of a primary TKA Proper tissue planes...

Page 9: ...e tibial component Excessive force to remove the components can lead to femoral fracture or extensive bone loss In case the patella was resurfaced previously with a balanSys Patella special atten tion...

Page 10: ...below the refresh cut when the reamer is in the final posi tion In a primary situation the markings should be app 8mm below the surface Remark Be very careful when reaming The balanSys Reamers are sh...

Page 11: ...est over the shaft until it reaches the level of the tibial osteotomy only required for the 140 and 200mm reamers Use the Positioning Fork 79 02 0029 to hold down the Guide Sleeve The Tibial Reference...

Page 12: ...raight The holes should be pre drilled with the Drill Bit 315 310 Remark Tibia shaft axis is orientated 90 to tibia plateau 0 posterior slope Hence rotational alignment does not influence the slope or...

Page 13: ...ation might be nec essary Insert the Tibial Cutting Guide 79 02 0290 again into the Aiming Device Proximal Depending on the thickness 5 or 10mm the correct slot needs to be chosen 1st Slot 5mm below s...

Page 14: ...the Memory Board 79 02 0637 to record the necessary augmentation in this example REV Tibial Augmentation LL RM 5mm If the medial and lateral augments have different heights use a saw or chisel in ord...

Page 15: ...nto the Tibial Template 79 02 0291 to 79 02 0295 Remark Scale can be read by the operator 12 o clock poste rior Insert the last used Reamer and check the depths The marking must be at least equal with...

Page 16: ...In this example the 4mm Offset Tibial Guide 79 02 0543 is used Use the Memory Board 79 02 0637 to record the required offset in this example a 4mm offset is re quired Special attention must be given t...

Page 17: ...rotation in this example 9 o clock Fix the Tibial Template with 4 Pins 71 02 3054 Remove all of the following instruments 1 Offset Tibial Guide 79 02 0541 or 79 02 0543 2 Offset Graduated Collar 79 02...

Page 18: ...Plateau Size markings are etched onto the Reamer marking must be flush with the end of the Reamer Guide After completing the preparation for the anchorage stem the PS Reamer and the Reamer Guide must...

Page 19: ...size of the Tibial Template Remove all remaining instruments except the Pins This steps are required if no or only one augmentation is selected Guide the Tibia Reamer 10 79 02 0279 over the Pins and...

Page 20: ...e Remark The orientation of the Test Stem Core is correct when it can no longer be rotated The laser marking is orien tated towards the Reference Plate Position the Trial Tibial Plateau 79 02 0060 to...

Page 21: ...w Positioner 79 02 0270 and insert the screw into the hole but do not tighten it yet Rotate the Offset Alignment Disk 79 02 0287 until the Reference Plate 77 02 0031 corresponds with the predetermined...

Page 22: ...e the Trial Stem Sleeve insert a Pin through the hole at the distal end and turn in the appropriate direction Click the Test Augmentations onto the lower surface of the Trial Tibial Plateau Remark The...

Page 23: ...ional stability if using medial and lateral Augmentations Open the screw and remove the Positioner Remark Leaving the test assembly in place during the femur preparation is recommended In case of usin...

Page 24: ...Check if the assessed femur size is compatible with the determined tibia size Appendix 1 Size Compatibility of the balanSys REV Implants Remark The Medical advisors recommend using a larger size if in...

Page 25: ...kings should be just below the refresh cut when the reamer is in the final posi tion In a primary situation the markings should be app 12mm below the joint line Slide the Guide Sleeve 79 02 0510 to 79...

Page 26: ...al cutting block of the 3in1 system 71 34 0682 onto the reamer using the distal cutting block guide of the 3in1 system 71 34 0683 and the clamp lever 71 34 0684V of the 3in1 system and the screw of th...

Page 27: ...distal condyles in those cases in which the native bone is still present and no resections have been carried out yet primary case Saw blade slot marked 0 for revisions those cases in which an primary...

Page 28: ...o make this adjustment loosen the screw holding the distal cutting block of the 3in1 system in place by turning the knob Now secure the distal cutting block of the 3in1 system to the femur with at lea...

Page 29: ...at have to be compensated for by means of augmentation choose the appropri ate saw blade slot Remark If permissible on the basis of the bone quality and if pin fixation is sufficient the connection to...

Page 30: ...ss of the inlay using the trial inlay for the spacer 79 02 0730 to 79 02 736 and the size 12 femoral spacer block 79 02 0652 In case of using a balanSys BICONDYLAR PS Tibia the tibial resection may be...

Page 31: ...right knee the R mark on the guide sleeve must correspond to the Right mark on the cutting block In the case of an offset stem introduce the size 4 fe mur offset guide 71 34 0652 into the offset sleev...

Page 32: ...be possible to turn the femur offset guide Slide the assembled combination cutting block of the 3in1 system plus the offset sleeve insert and the offset guide onto the shaft of the reamer Then push th...

Page 33: ...d if no offset is re quired this step is superfluous Turning the femur offset guide will also cause the AP position to change and this has an impact on the flexion gap All adjust ments also affect the...

Page 34: ...ral spacer block 79 02 0652 If the ligament tension is too taut choose a smaller femoral component if possible If the ligament tension is too lax choose a larger femoral component if possible To deter...

Page 35: ...part of the cutting block of the 3in1 system Now carry out the femur cuts in the following order anterior posterior anterior chamfer cut Description of the inferior cutting surfaces of the AP cutting...

Page 36: ...or the posterior condyles Saw blade slot marked 10 for a 10mm augmentation Saw blade slot marked 5 for a 5mm augmentation Saw blade slot marked 0 for revisions cases in which an original prosthesis wa...

Page 37: ...ase of the stem to be reamed the cutting block of the 3in1 system must be fitted back onto the straight pins so that it will be placed in exactly the same position again The cutting block of the 3in1...

Page 38: ...en Remark The orientation of the Test Stem Core is correct when it can not be rotated any more The laser marking is orientated towards the Reference Plate Click the Test Augmentations onto the Trial F...

Page 39: ...Trial Femur The cam of the box should face towards posterior The surface of the Trial Femur and the Femur Box Inlay must align smoothly Assemble the Offset Alignment Disk 79 02 0287 and the Box Adapt...

Page 40: ...ition The 12 o clock position must face to wards anterior Snap in the Trial Stem Screw 79 02 0071 onto the Screw Positioner 79 02 0270 and insert the screw into the hole but do not tighten it yet Rota...

Page 41: ...ig 86 In this example the 3 o clock position was measured Remove the Offset Alignment Disk Tighten the Trial Stem Screw with the Hexagonal Screwdriver 314 270 Put the appropriate Trial Stem Sleeve pre...

Page 42: ...al Stem Sleeve insert a Pin through the hole at the distal end and turn in the appropriate direction Take the femur box inlay 79 02 0470 to 79 02 0474 out again The box has not been prepared yet Inser...

Page 43: ...ser marking It is advisable to use a narrow saw blade guiding it along the sagittal surfaces of the trial femur When the pins are touched the resection will be stopped Then carry out the transverse re...

Page 44: ...hang and osteophytes with the Osteophyte Chisel 71 02 3007 Depending on ligament stability a REV Trial Inlay or a PS Trial Inlay can be used Remark It might be advisable to ventralize the tibia as muc...

Page 45: ...r form the patellar osteotomy and to position the pa tellar trial component before the knee is tested With all the trial revision components in place the knee is tested with respect to range of motion...

Page 46: ...off 4 uncemented Position the chosen balanSys REV Tibial Plateau onto the Assembly Device reverse side Unpack the chosen balanSys REV Augmentations and screw the implants to the lower surface of the...

Page 47: ...al end of the chosen balanSys REV Stem into it Tighten the fixation screw of the black Assembly Device Remark There is a marking on the stem this marking must be orientated towards the Reference Plate...

Page 48: ...strument consists of 3 parts Positioner Handle 79 02 0301 Positioner Rod 79 02 0302 Sizing Ring Positioner 79 02 0303 The necessity to use and the side of the Sizing Ring Positioner is defined by the...

Page 49: ...e and snap the Positioner Rod through the hole Insert the Positioner Rod with the thread into the opening of the tibial plateau and turn the positioner device in a clockwise direction The threads of t...

Page 50: ...usage of CR UC or PS Inlays In case of using balanSys BICONDYLAR CR UC or PS Inlays the positioner must be removed and the stem screw must be used Tighten the stem screw with the Torque Wrench 18 410...

Page 51: ...and lateral balanSys REV Femur Augmentation C 5 dorsal Position the chosen balanSys REV Femur onto the Fe mur Assembly Block 79 02 0540 Unpack the chosen balanSys REV Augmentations and screw the impla...

Page 52: ...the Assembly Device Insert the Reference Plate 77 02 0031 in the slot of the black Assembly Device and insert the distal end of the chosen balan Sys REV Stem into it Tighten the fixation screw of the...

Page 53: ...ition The 12 o clock position must face to wards anterior Use the Offset Alignment Disk to set the measured rotation Insert the stem screw onto the Screw Positioner 79 02 0270 and insert the screw int...

Page 54: ...ew with the Hexagonal Screw driver 314 270 Remove the Offset Alignment Disk 79 02 0287 Use the Femoral Impactor 71 34 0699 to hit the femur only once Tighten the stem screw with the Torque Wrench 18 4...

Page 55: ...mmer Remove excess cement carefully In case of using a balanSys BICONDYLAR Inlay remove the Positioner after implanta tion and re tighten the stem screw with the Torque Wrench 18 410 RAL5002 with 2 cl...

Page 56: ...al Inlay may be inserted during the hardening of the bone ce ment After hardening the Trial Inlay must be re moved Afterwards the correct balanSys REV Inlay must be inserted Insert the stabilization s...

Page 57: ...f the component with the Torque Wrench 3 5 with 2 clicks while counteracting thetorquewiththeNeckStopperCurved 79 02 0750 After implantation the stem screw must be re tightened with the Torque Wrench...

Page 58: ...with balanSys BICONDYLAR PS Inlay 60 2 3 Optional combination balanSys REV Tibia with balanSys BICONDYLAR Inlays 61 3 Item numbers of the balanSys REV Implants 62 4 Packaging of screws for the balanS...

Page 59: ...sides femoral and tibial balanSys REV Femur with REV Inlay and Tibia The balanSys REV Inlay cannot be used in combination with any balanSys BICONDYLAR Femur or Tibia balanSys REV Inlays may only be u...

Page 60: ...REV Femur can be used in combination with the balanSys BICONDYLAR PS Inlay PE or vita mys balanSys REV Femurs must not be used in combination with balanSys BICONDYLAR CR UC or RP Inlays balanSys REV...

Page 61: ...d in combination with balanSys REV Femurs and balanSys REV Tibias 2 3 Optional combination balanSys REV Tibia with balanSys BICONDYLAR Inlays Remark balanSys BICONDYLAR CR and PS Femurs of size XS can...

Page 62: ...rMo balanSys REV Femur Augmentation distal Item no Size Item no Size 79 15 0221 A 5 79 15 0242 C 10 79 15 0222 A 10 79 15 0251 D 5 79 15 0231 B 5 79 15 0252 D 10 79 15 0232 B 10 79 15 0261 E 5 79 15 0...

Page 63: ...13mm 79 30 0106 64mm 23mm 79 30 0133 80mm 15 5mm 79 30 0111 70mm 10 5mm 79 30 0134 80mm 18mm 79 30 0112 70mm 13mm 79 30 0135 80mm 20 5mm 79 30 0113 70mm 15 5mm 79 30 0136 80mm 23mm 79 30 0114 70mm 18...

Page 64: ...70 5 LL RM 79 15 0184 80 10 LL RM 79 15 0163 70 10 LM RL 79 15 0191 85 5 LM RL 79 15 0164 70 10 LL RM 79 15 0192 85 5 LL RM 79 15 0171 75 5 LM RL 79 15 0193 85 10 LM RL 79 15 0172 75 5 LL RM 79 15 019...

Page 65: ...79 15 0088 17mm 140mm 79 15 0083 12mm 140mm 79 15 0089 18mm 140mm 79 15 0084 13mm 140mm 79 15 0090 20mm 140mm 79 15 0085 14mm 140mm 79 15 0091 22mm 140mm 79 15 0086 15mm 140mm 79 15 0092 24mm 140mm Ma...

Page 66: ...79 15 0138 17mm 140mm 79 15 0133 12mm 140mm 79 15 0139 18mm 140mm 79 15 0134 13mm 140mm 79 15 0140 20mm 140mm 79 15 0135 14mm 140mm 79 15 0141 22mm 140mm 79 15 0136 15mm 140mm 79 15 0142 24mm 140mm Ma...

Page 67: ...FLAT components Item no Diameter 72 34 0049 26mm 72 34 0050 28mm 72 34 0051 31mm 72 34 0052 34mm 72 34 0053 37mm Material UHMWPE FeCrNiMoMn Contrast balls balanSys 3 Peg Patella components Item no Dia...

Page 68: ...ouch 1 Stems Description Qty Packed with 1 Stem Screw The screw is partially screwed onto the stem In case of use of a REV Inlay this Stem Screw must be discarded since the fixation is achieved with t...

Page 69: ...8 balanSys REV Tray Basic No 2 page 70 balanSys REV Tray Basic No 3 with Insert page 72 74 balanSys REV Tray Basic No 4 page 76 The Set Number is 71 34 0740A it consists of the following 7 Trays and t...

Page 70: ...with Insert page 84 87 Before each surgery instruments should be checked for damage or deformation Use only undamaged instruments Do not use trial components with marks or scratches balanSys REV inst...

Page 71: ...balanSys REV Extension Gap First 3in1 71 Basic No 1 No Picture 71 34 0042 balanSys REV Lid Basic No 1 balanSys REV 3in1 Instrumentation Set 71 34 0740A 71 34 0041 balanSys REV Tray Basic No 1...

Page 72: ...mur 12 1 Item no Description Qty 79 02 0660 balanSys REV Spacer block agm L 5 2 79 02 0661 balanSys REV Spacer block agm R 5 2 79 02 0662 balanSys REV Spacer block agm L 10 2 79 02 0663 balanSys REV S...

Page 73: ...balanSys REV Extension Gap First 3in1 73 Basic No 2 No Picture 71 34 0047 balanSys REV Lid Basic No 2 71 34 0046 balanSys REV Tray Basic No 2...

Page 74: ...79 02 0325 balanSys REV reamer 25 1 Item no Description Qty 79 02 0510 balanSys REV Guide sleeve 10 1 79 02 0511 balanSys REV Guide sleeve 11 1 79 02 0512 balanSys REV Guide sleeve 12 1 79 02 0513 ba...

Page 75: ...balanSys REV Extension Gap First 3in1 75 Basic No 3 No Picture 71 34 0053 balanSys REV Lid Basic No 3 71 34 0051 balanSys REV Tray Basic No 3...

Page 76: ...balanSys REV Trial stem sleeve 13 140 1 79 02 0694 balanSys REV Trial stem sleeve 14 140 1 79 02 0695 balanSys REV Trial stem sleeve 15 140 1 79 02 0696 balanSys REV Trial stem sleeve 16 140 1 79 02 0...

Page 77: ...02 0021 balanSys PS machine coupling f reamer 1 Item no Description Qty 18 410 RAL5002 Torque wrench 1 Item no Description Qty 71 02 3054 balanSys pin 3 2 80 4 Item no Description Qty 79 02 0281 balan...

Page 78: ...no Description Qty 71 02 3016 balanSys femur holder 1 Item no Description Qty 71 34 0699 balanSys femoral impactor 1 Item no Description Qty 71 34 0698 balanSys tibial impactor 1 Item no Description...

Page 79: ...70 04 0109 balanSys alignment rod centre piece 1 Item no Description Qty 70 04 0110 balanSys alignment rod short 1 Item no Description Qty 70 04 0111 balanSys alignment rod long 1 Item no Description...

Page 80: ...y 71 02 3042 balanSys Trs intramedullary rod 1 Item no Description Qty 71 02 3054 balanSys pin 3 2 80 10 Item no Description Qty 77 02 0031 balanSys reference plate 1 3 2 Item no Description Qty 71 02...

Page 81: ...Description Qty 77 02 0019 balanSys Trs screw 1 Item no Description Qty 77 02 0041 balanSys Trs connecting screw 1 Item no Description Qty 77 02 0043 balanSys Trs locking bolt 1 Item no Description Qt...

Page 82: ...Item no Description Qty 79 02 0286 balanSys PS reamer guide 1 Item no Description Qty 71 34 0700 balanSys handle for tib cutting chisel 1 Item no Description Qty 71 34 0240 balanSys positioner for tib...

Page 83: ...Sys REV Tibial Template 80 1 79 02 0295 balanSys REV Tibial Template 85 1 Item no Description Qty 79 02 0279 balanSys REV Tibia reamer 10 1 Item no Description Qty 79 02 0541 balanSys REV offset tibia...

Page 84: ...l tibia agm 70 10 LL RM 1 79 02 0172 balanSys REV trial tibia agm 75 5 LM RL 1 79 02 0173 balanSys REV trial tibia agm 75 5 LL RM 1 79 02 0174 balanSys REV trial tibia agm 75 10 LM RL 1 79 02 0175 bal...

Page 85: ...1 79 02 0331 balanSys REV trial femur A left 1 79 02 0332 balanSys REV trial femur B right 1 79 02 0333 balanSys REV trial femur B left 1 79 02 0334 balanSys REV trial femur C right 1 79 02 0335 balan...

Page 86: ...istal trial agm femur C 10 2 79 02 0451 balanSys REV distal trial agm femur D 5 2 79 02 0452 balanSys REV distal trial agm femur D 10 2 79 02 0461 balanSys REV distal trial agm femur E 5 2 79 02 0462...

Page 87: ...nSys REV Neck stopper straight 1 Item no Description Qty 79 02 0288 balanSys REV box adapter 1 Item no Description Qty 79 02 0301 balanSys REV positioner handle 1 Item no Description Qty 79 02 0302 ba...

Page 88: ...w large 1 Item no Description Qty 71 34 0651 balanSys REV 3in1 Femur offset guide 0 1 Item no Description Qty 71 34 0652 balanSys REV 3in1 Femur offset guide 4 1 Item no Description Qty 71 34 0655 bal...

Page 89: ...10 2 71 34 0674 balanSys REV 3in1 Augmentation C 5 2 71 34 0675 balanSys REV 3in1 Augmentation C 10 2 71 34 0676 balanSys REV 3in1 Augmentation D 5 2 71 34 0677 balanSys REV 3in1 Augmentation D 10 2...

Page 90: ...ial inlay 64 23 1 79 02 0361 balanSys REV PE trial inlay 70 10 5 1 79 02 0362 balanSys REV PE trial inlay 70 13 1 79 02 0363 balanSys REV PE trial inlay 70 15 5 1 79 02 0364 balanSys REV PE trial inla...

Page 91: ...balanSys REV PE trial inlay 80 18 1 79 02 0385 balanSys REV PE trial inlay 80 20 5 1 79 02 0386 balanSys REV PE trial inlay 80 23 1 79 02 0391 balanSys REV PE trial inlay 85 10 5 1 79 02 0392 balanSy...

Page 92: ...rgery The balanSys REV Instrument Set includes 2 Memory Boards The idea is to use one in the sterile area to record and to transfer the information to the one in the non sterile area The non sterile o...

Page 93: ...1 644 Fax 41 32 644 1 161 www mathysmedical com Measuring template balanSys REVISION Tibia Item no 330 030 026_B 02 1110 04 2010 11 Mathys Ltd Bettlach Tibia Size 64 for Femur Size A B Augmentation P...

Page 94: ...nnecting screw 77 02 0041 7 7 Insert the Tibial Cutting Guide 79 02 0290 8 onto the Aiming Device Proximal 71 02 3032 6 8 Set the REV Tibial Cutting Guide 79 02 0290 8 to zero and tighten the screw 9...

Page 95: ...balanSys REV Extension Gap First 3in1 95 Manufacturer Caution Symbols...

Page 96: ...sdorf 07646 M rsdorf Th r Tel 49 364 284 94 0 info de mathysmedical com Centre of Excellence Production Hermsdorf 07629 Hermsdorf Tel 49 364 284 94 110 info de mathysmedical com Italy Mathys Ortopedia...

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