Turon Product Brochure
2015-06-04
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TM Turon™ Modular Shoulder System Product Guide Dial In Dial In Notes Humeral Head Trialing Humeral Head Osteotomy • A well done humeral osteotomy requires that the surgeon make the osteotomy cut at or very near the patient’s anatomic neck and avoids an aggressive cut which could destabilize the rotator cuff. • Failure to remove the posterior osteophytes can result in a difficult glenoid exposure. Glenoid Faceplate Preparation • The Glenoid Drill Guide Handle (804-25-040) has a spring-loaded threaded tip. To ensure proper assembly, the “spring-loaded” tip must be flush against the Glenoid Sizing/Drill Guide, 38mm– 54mm (804-25-101_105) prior to engaging the threads. The spring-loaded tip is designed to help prevent cross-threading and secure a tight fit. • Correction of glenoid version should rarely exceed 10 degrees as this could compromise bone stock. If greater degrees of correction are necessary, it may be prudent to use a keeled component. Pegged Glenoid Technique • The inferior pegs of the 38mm Pegged Glenoid (520-01-238) are shorter than to the other Pegged Glenoid sizes. This is why there is a separate 38mm Peg Drill Guide (804-25-124). • Ensure the 5.0mm Stop Drill (804-25-147) is in proper “in-line” alignment with the Glenoid Drill Guides and free from any soft tissue interference. Improper alignment can lead to stripping and/or binding of the drill against the drill guide. Head/Neck/Stem Interferences Depending upon whether a Straight or an Angled Neck is used, there are certain humeral head and stem configurations that are not compatible and may cause head/stem interferences. A listing of these head/stem interferences is provided to the right. 2 • When trialing with the Angled Neck Trial in combination with an Offset Humeral Head Trial, be sure to note the position of the Angled Neck Trial and the Offset Humeral Head Trial relative to the osteotomy surface. • It is recommended to dial in and record the desired position of the Angled Neck Trial prior to recording the determined position of the Offset Humeral Head Trial. • If preferred, humeral head trialing may be performed off the final stem. After glenoid implantation, the surgeon may desire to proceed immediately to final humeral stem implantation and perform humeral head trialing off the final stem. • For instances when the Trial Necks are difficult to remove, the Humeral Neck Extractor can be used. Stem Straight Neck Angled Neck Size 6 38 mm x 18 mm Offset Humeral Head Size 8 38 mm x 18 mm Offset Humeral Head Size 10 38 mm x 18 mm Offset Humeral Head Size 12 Size 14 38 mm x 18 mm Offset Humeral Head 42 mm x 16 mm Offset Humeral Head 38 mm x 18 mm Offset Humeral Head 38 mm x 18 mm Offset Humeral Head 42 mm x 16 mm Offset Humeral Head 42 mm x 16 mm Offset Humeral Head 38 mm x 18 mm Offset Humeral Head 42 mm x 16 mm Offset Humeral Head Size 16 38 mm x 18 mm Offset Humeral Head 42 mm x 20 mm Offset Humeral Head 46 mm x 16 mm Offset Humeral Head 38 mm x 14 mm Neutral Humeral Head 38 mm x 18 mm Offset Humeral Head 42 mm x 16 mm Offset Humeral Head 42 mm x 20 mm Offset Humeral Head 46 mm x 16 mm Offset Humeral Head INTERNAL USE ONLY Dial In Humeral Head and Glenoid Radius of Curvature Mismatch The Turon system is designed with a radius of curvature mismatch between the humeral heads and the glenoid components. The mismatch is different in the A/P and I/S planes to optimize stability while allowing translational articulation. Highlighted size pairings represent recommended mismatches (see matrices). Proximal Humeral Preparation for Lesser Tuberosity or Subscapularis Repair • It is preferred to stagger drill holes to avoid fracture of the greater tuberosity Humeral Stem Press-fit Technique • If desired, use cancellous bone from the resected humeral head to perform impaction bone grafting or to bone graft any small defects and ensure a secure press-fit. Humeral Implant Assembly • For instances when an Angled Humeral Neck is used in combination with an Offset Humeral Head, be sure to position or dial in the desired position of the Angled Humeral Neck relative to the Offset Humeral Head prior to initiating the Morse taper. INTERNAL USE ONLY I/S Radius of Curvature Mismatch (mm) Glenoids Humeral Heads Size 38 Size 42 Size 46 Size 50 Size 54 Size 38 8* 6 4 2 0 Size 42 10 8 6 4 2 Size 46 12 10 8 6 4 Size 50 14 12 10 8 6 Size 54 16 14 12 10 8 A/P Radius of Curvature Mismatch (mm) Glenoids Humeral Heads Size 38 Size 42 Size 46 Size 50 Size 54 Size 38 12* 10 8 6 4 Size 42 14 12 10 8 6 Size 46 16 14 12 10 8 Size 50 18 16 14 12 10 Size 54 20 18 16 14 12 *Size pairing in gray represent recommended mismatch 3 Dial In Frequently Asked Questions (FAQ) 1 General 1. Will Turon replace Foundation? If so, what will happen to the Foundation Fracture System? Yes, Turon will replace the Foundation Shoulder System. This will not happen overnight and there will be ample communications on the Foundation phaseout plan. The Foundation Fracture System will not be phased out and will continue to be supported. 2. What is the IMIN™ neck technology? What does IMIN stand for? Does any other company have a similar technology? The IMIN™ neck technology is designed to help surgeons dial in to restore patient anatomy, optimize joint stability, and improve range of motion. IMIN is an acronym for Intrinsic Modular Indexable Neck. Turon is the first total shoulder system to incorporate this technology. No other company has this technology as it is patented and owned by DJO Surgical. The IMIN neck technology originates from our hip stems and is currently used in our R-120 and Alfa II hip stems. 3. What does Turon stand for? The name Turon does not stand for anything. When the name Turon was conceived, it had no reference and/or bearing to any popular culture, theme or translations. Coincidentally, Turon does translate to “Polecat” in Spanish and is also a Philippine banana snack – which are pretty funny. 4. What is a “Ream-and-Run” technique? Do we have instruments for that? The “Ream and Run” surgical technique was developed by Dr. Frederick A. Matsen, III, of UW Washington Medicine, Orthopedics and Sports Medicine, and involves using smooth-faced glenoid reamers to plane off and remove damaged cartilage, bony defects, and/or glenoid biconcavities during shoulder hemiarthroplasty, in which, no glenoid implant is used. “…the “ream and run” approach may allow active patients to remain involved in fitness, recreational, 4 and vocational pursuits that would risk premature failure if traditional total shoulder arthroplasty were to be performed.”1 Currently, DJO Surgical does not offer dedicated instrumentation for this procedure. 1 http://www.orthop.washington.edu/reamandrun 5. Are there any Turon sample sets, demo instrument sets and/or acrylic models? There are currently 20+ Turon sample demo kits, of which, 7 are currently consigned and 13 are in circulation. There are 4 marketing instrument sets, 3 of which are complete and 1 is incomplete, for demonstrations, lab and meeting support. Rendered plastic implant acrylic models are available for order and demonstration purposes. Please contact Rae Pepper at Rae.Pepper@djoglobal.com to place an order. 6. Are there digital templates for Turon? How do I find out if my hospital or surgery center has access to digital templates for Turon? Yes, digital templates are available for Turon. In order to learn whether your hospital or surgery center has access to the digital templates, you must first find out and communicate to DJO Surgical the Medical Imaging and PACS (Picture Archiving and Communication) system used at that facility. In the event that your facility does not have access to Turon digital templates, it may take up to 3 months to process the request. We encourage you to ask your facility and begin the process as early as possible. Alternatively, hardcopies of the Turon x-ray template (804-88-117) are available for order through Customer Service. 7. Is the angle of retroversion of the humerus (shoulder joint) always 30°? How is it referenced? No, it is not. The normal angle of retroversion of the humerus is between 20° and 40°, with the average of 30° as the generally accepted standard. “The angle of retroversion is the angle formed by a line drawn through the center of the longitudinal INTERNAL USE ONLY Dial In Frequently Asked Questions (FAQ) axis of the neck and head of the humerus meeting a line drawn along the transverse axis of the condyles, when the base is viewed from above, looking straight down from above the head of the humerus; the normal angle of retroversion of the humerus is between 20 and 40 degrees (see Figure below).”2 2 Instrument 10. Does Turon instrument set have the same retractors, i.e. – plastic darrach (t-shaped), brown deltoid, two-prong glenoid, as in the RSP instrument set? What retractors are available? No, there are no retractors in the Turon instrument trays. There are currently 3 dedicated Shoulder Retractor loaner sets available through Distribution Services. Retractors and quantities in the Shoulder Retractor Sets are as follows: Qty 2. www.medilexicon.com 8. What is the correct amount of height difference between the superior aspect of the humeral head to the greater tuberosity? “The articular head always lies above the greater tuberosity, but the difference can range from 3-20mm.”3 Your surgeon will determine the correct amount of height difference within this range. The generally accepted difference is about 8mm. 3 http://emedicine.medscape.com/article/1261320-overview#a04 9 . Who are the surgeon designers of the Turon? Mark A. Frankle, MD – Florida Orthopedic Institute, Tampa, FL Mark A. Mighell, MD – Florida Orthopedic Institute, Tampa, FL Richard J. Hawkins, MD – Steadman Hawkins Clinic of the Carolinas, Greenville, SC Keith C. Watson, MD – Orthopedic Specialty Associates, Fort Worth, TX Spero G. Karas, MD – Emory Sports Medicine Center, Atlanta, GA Part No. Description 1 804-00-097 Glenoid Protector 1 804-00-098 Deltoid Retractor 1 804-00-099 Humeral Retractor 1 804-00-200 Darrach, Small 1 804-00-201 Darrach, Large 2 804-00-202 Spiked Hohmann 1 804-00-203 Anterior Glenoid 1 804-00-204 Small Pectoral 11. The OR staff has a hard time attaching the Glenoid Drill Guide Handle (804-25-040) to the Glenoid Sizing/Drill Guide, 38mm – 54mm (804-25142_146). What would you recommend? Is there an alternative handle we can use? The Glenoid Drill Guide Handle has a spring-loaded threaded tip. To ensure proper assembly, the springloaded tip must be flush against the Glenoid Sizing/ Drill Guide prior to engaging the threads. To facilitate attachment, it is recommended to thread the drill guide into the handle rather than the handle to the drill guide. Alternatively, there are two Glenoid Pressurizer/ Pusher Handles (804-25-037) available than can be used as substitutes. Please note that only the first thread or two of these handles are sufficient to engage the drill guide. Lastly, the Foundation Shoulder Glenoid Template Handle (804-01-013) can also be used as a substitute. Theodore F. Schlegel, MD – Steadman Hawkins Clinic Denver, Denver, CO INTERNAL USE ONLY 5 Dial In Frequently Asked Questions (FAQ) 12. Is the backside curvature or spherical radius the same for all the Turon Glenoid Reamers, 38mm – 54mm (804-25-142_146)? What about for Turon, Foundation, and RSP? While the diameter sizes are different among the Turon glenoid reamers, the backside curvature or the spherical radius, which is 38mm, is the same for all glenoid reamers. This is also true for Turon, Foundation, and RSP. 13. The Proximal Humeral Protector, Small/Large (804-05-148_149)/Planer Guide, Straight/Angled Neck (804-05-052_053)/Neck Trial, Angled/Straight (804-15-005_006) is stuck on the Humeral Broach, 6mm – 16mm (804-05-106_116)/Humeral Stem, 6mm – 16mm (520-01-006_016) implant, what should I do? The Humeral Neck Extractor (804-15-003) is available to extract any of the above mentioned instruments and implants. 18. Are there dedicated revision instruments? Yes, there are dedicated revision instruments. Below is a listing of the revision and related instruments. Please refer to the “Revision” section of the Turon surgical technique. • Head Distractor (804-05-046) • Humeral Neck Extractor (804-15-003) and Ratcheting Handle (804-05-163) • Stem Extractor (804-05-047) • Humeral Broach Handle (804-05-007) 19. The plastic cap on the Glenoid Drill Guide Pusher (804-25-132) is damaged or missing, is there a replacement? Yes, the part number for the Glenoid Drill Guide Pusher Replacement Cap is (804-25-232). Please contact Customer Service for a replacement. 14. What do the depth lines on the Humeral Reamers, 6mm – 16mm (804-05-086_091) represent? 20. The screw to the Back Table Fixture (804-15102) is damaged or missing, is there a replacement screw? Starting from top to bottom or proximal to distal, the depth lines on the humeral reamers are “REVISION” for revision or long stem, “CEMENT” for cemented application, and “PRESS FIT” for press-fit application. Yes, the part number for the Back Table Fixture Screw Replacement is (804-15-202). Please contact Customer Service for a replacement. 15. Are the Turon humeral reamers the same as the RSP reamers? What about the broach handles? No, both the RSP humeral reamers and broach handles are different from Turon. 16. Is there separate instrumentation for the revision/long humeral stems? No, there is no dedicated revision/long humeral stem instrumentation. The same humeral reamers and broaches are used for revision/long stem applications. Please refer to the Revision/Long Stem section of the surgical technique. 3 Implant 21. What are the lengths of the primary and revision humeral stems? Are they offered in the same diameter sizes? The tables below summarize the humeral stem lengths for both primary and revision/long stems. Both are offered in diameters 6, 8, 10, 12, 14 and 16 mm diameter sizes. Length is measured from the proximal apex to the distal tip of the humeral stem. 17. How do I order revision/long humeral stems (520-01-106_116) should my surgeon request them? Revision/long humeral stems can be ordered through Distribution Services as loaner banks. 6 INTERNAL USE ONLY Dial In Frequently Asked Questions (FAQ) PRIMARY HUMERAL STEMS Cat. No. Size (mm) Length (mm) 520-01-006 6 115 520-01-008 8 114 520-01-010 10 113 520-01-012 12 112 520-01-014 14 111 520-01-016 16 110 REVISION/LONG HUMERAL STEMS Cat. No. Size (mm) Length (mm) 520-01-106 6 200 520-01-108 8 199 520-01-110 10 198 520-01-112 12 197 520-01-114 14 196 520-01-116 16 195 22. Why is a reverse (a.k.a. – female) Morse taper important? A reverse or female Morse taper provides for an unobstructed access and preparation of the glenoid face compared to a standard or male Morse taper, such as in the Foundation stems. 23. What is the advantage to a collared humeral stem design? A collared stem helps to prevent subsidence during in situ (in the body) implant assembly. 24. Do the humeral heads sit flush on the humeral osteotomy? Is there any gapping between the humeral head and the osteotomy similar to Foundation? The humeral heads are designed to seat on the humeral necks with some clearance between the underside of the head and the osteotomy. This is to INTERNAL USE ONLY prevent the risk of non-engagement of the Morse taper during in situ (in the body) implant assembly. This clearance is minimal, up to 3.81mm (1.4mm visible gap between the top of the humeral stem collar and the humeral head) at its greatest, between the humeral head and osteotomy, and can be imperceptible on radiographs. This clearance is not to the extent of the gapping seen on Foundation, which is about 5mm. 25. Are the Foundation and Turon humeral heads compatible and interchangeable with each system’s respective humeral stems? Other than differences in humeral head height offerings, the Turon and Foundation humeral heads are equivalent and are compatible and interchangeable. The Foundation humeral head heights are 17/22/27mm for all diameter sizes, i.e. – 38, 42, 46, 50, 54mm. Whereas, the Turon heights are 38mm x 14/16mm, 42/46mm x 14/16/20mm, and 50/54mm x 18/22/26mm. Note: There are no humeral head trials to allow for interchangeable humeral head trialing between the two shoulder systems. 26. What is the amount of offset on the Offset Humeral Heads? The offset for all humeral head sizes is 4mm. 27. Why is there not a 38mm x 14mm offset humeral head size? It was not possible to design a 4mm offset into a size 38mm x 14mm humeral head. 28. In what situations would the Angled (7.5-degree) Humeral Neck (520-00-001) be used? The angled humeral neck would help treat patients with variable neck-shaft angles that are not 135° to allow for proper biomechanics and the reproduction of the humeral center of rotation. 7 Dial In Frequently Asked Questions (FAQ) 29. What is the amount of press-fit on the humeral stems? 32. What is the tiny metal wire that is embedded in the glenoids central keel and superior peg for? The proximal plasma spray on the Turon humeral stems provides a 0.5mm overall press-fit. It is a titanium wire that serves as a radiographic marker to assess and view glenoid placement and positioning. 33. Are the humeral stems similar between Turon and Foundation? No. The Turon humeral stem is shorter and has a smaller proximal body compared to the Foundation humeral stem. It also has a reverse or female Morse taper design versus a standard or male Morse taper design. Additionally, the lateral aspect of the proximal body is reduced and there is no lateral fin. Lastly, the Turon humeral stems have the patented IMIN neck technology designed into them. (0.25mm each side) 30. In what situations would the medial hole and the anterior and posterior fin suture holes on the humeral stem be used? These holes are all suture holes and are primarily used for tuberosity repair and fixation during 3 and 4-part proximal humeral fracture repair in hemiarthroplasty. They can also be used for adjunctive soft tissue repair and implant fixation for hemiarthroplasty and total shoulder arthroplasty. 31. What is the purpose of the recess (see below Figure with red arrow) at the medial aspect under the collar of the humeral stem? The recess is designed for the tip of the Stem Extractor (804-05047) to seat into during humeral stem removal. 8 34. What is the purpose of humeral head and glenoid mismatch? There is a natural anatomical mismatch in the radius of curvature between the humeral head and glenoid face that contributes to proper shoulder joint biomechanics. In simpler terms, the humeral head curvature is (generally) smaller than the glenoid face curvature. 4 This mismatch, specifically for shoulder implants, ranges from 0 to 10mm, with some studies showing an optimal mismatch range between 6 and 10mm.5 Restoring proper glenohumeral mismatch in shoulder arthroplasty contributes to a successful surgical outcome. ”The normal glenohumeral relationships. An anatomical study of one hundred and forty shoulders.” Iannotti et al, J Bone Joint Surg Am. 1992 Apr; 74(4):491-500. 4 5 ”The influence of glenohumeral prosthetic mismatch on glenoid radiolucent lines: results of a multicenter study.” Walch et al, J Bone Joint Surg Am. 2002 Dec;84-A(12):2186-91. 35. Can my surgeon upsize or downsize the humeral head and glenoid size pairing? We cannot advise surgeons how to upsize or downsize humeral head and glenoid size pairings as it is an OFF-LABEL use. However, we can inform surgeons what the humeral head and glenoid mismatch values are among different size pairings by referring them to the “Humeral Head and Glenoid Radius of Curvature Mismatch Chart”. Only the INTERNAL USE ONLY Dial In Frequently Asked Questions (FAQ) surgeon can decide or opt to mismatch humeral head and glenoid size pairings. 4 Conversion: Turon-RSP 36. The pegs are too long on the glenoid, can we cut them down? 41. Will my surgeon be able to convert the Turon to an RSP? Yes. Yes, the Turon-RSP conversion adaptors are available. The Turon to RSP Conversion Module Trials, Offset (804-02-074) and Neutral (804-02-073), will be backfilled with the Turon instrument sets and will be housed in miscellaneous box in the Turon Humeral Head Case. The Turon to RSP Conversion Module Implants, Offset (508-02-001) and Neutral (508-02000), are available through Distributor Services. 37. What is the neck shaft-angle on the humeral stem? The humeral neck-shaft angle is 135°. Depending on reference point, it can also be referred to as 45°. 38. How is the humeral neck-shaft angle determined? 45⁰ Using an anteroposterior (A/P) radiograph, the humeral neck-shaft angle is determined 135⁰ by the intersection of a line drawn on the central axis of the humeral shaft (A) with a line C drawn perpendicular to the anatomical neck (B) of the humerus.6 6 http://www.springerimages.com/ImagesMedicineAndPublic Health/1-10.1007_s10195-008-0019-1-1 39. What is the difference in length between the superior peg and the inferior pegs of the pegged glenoid? Why the difference? For the size 38mm glenoid only, the difference between the longer superior peg and shorter inferior pegs is 3.6mm. All other sizes, i.e. – 42 to 54mm, the difference is 1.7mm. 42. Can we promote the Turon humeral stem combined with the Turon-RSP conversion adaptor to our surgeons as a “press-fit” reverse shoulder? No, the promotion and use of the Turon humeral stem with the Turon-RSP conversion adaptor as a “press-fit” reverse shoulder is strictly OFF-LABEL. 43. Can we use Turon humeral heads with the hemi adaptors for the RSP when converting to a hemiarthroplasty? Yes. Dedicated Modular RSP to Turon Conversion Module Trials have been backfilled to existing Turon instrument sets and are housed in the miscellaneous box in the Turon Humeral Head Case. The trials come in two sizes, 6mm (804-02-076) and 12mm (804-02-077). 5 Surgical Technique/Procedure 44. The humeral shaft fractured during humeral broaching/reaming, what should we do? 40. What is the backside curvature for the Turon and Foundation glenoids? Regardless of experience, situations like these are often tough and very unpredictable. However, there are certain surgical cases that provide information to help preempt and prepare for these tough situations, such as, a revision of a press-fit or cemented humeral stem, humeral shaft deformities and malunions, short and/or narrow humeral canals – are just a few examples. The backside curvature for all Turon glenoids is 38mm. To prepare for or in the midst of these situations, be sure that the OR staff has access to any of the The difference in lengths is attributed to the anatomy of the glenoid, where the glenoid vault is generally larger superiorly. INTERNAL USE ONLY 9 Dial In Frequently Asked Questions (FAQ) following listed to help with fracture repair and completing the surgical procedure. • Revision/long humeral stem • C-arm or fluoroscope • Cable set • Bone cement removal device (if revising/ removing a cemented stem) • Small Fragment Set • Allograft/grafting agent Note: This is just an example list and should not be viewed as standard list for all fracture situations. 45. When using an offset humeral head, how does a surgeon mark or reference the determined humeral head offset position on the humeral osteotomy? Each surgeon will have their own method to mark or reference the position of the humeral head offset. A common practice is to use an electrocautery or surgical pen to mark the offset position on the humeral osteotomy surface via a determined landmark, such as the bicipital groove. 46. After the surgeon planed the humeral osteotomy with the planer disk and guide, there is some residual bone. What should we do? Remove any residual bone with a small burr or other preferred methodology to assure there are no bony impediments. 47. What should we do when we are in between sizes among humeral stems? Humeral heads? Glenoids? In the event that your surgeon is in between sizes among humeral stems, heads or glenoids, it is prudent to go smaller versus larger to prevent the risks of stress fracture, joint overstuff, implant overhang, or impingement. 48. My surgeon is experiencing difficulty dislocating the humeral head, what should I advise? In order to dislocate the humeral head, the dissection should be directed to the medial humeral neck. To accomplish this requires that the arm is 10 externally rotated and the capsule is released from anterior to posterior along the medial humeral neck. Dislocate the head anteriorly by carefully externally rotating and extending the arm. Gentle leverage from a Darrach or Hohmann retractor facilitates humeral head dislocation and helps retract the medial soft tissues of the subscapularis, pectoralis major, and conjoined tendon. To reduce the incidence of intra-operative humeral shaft fracture, gentle external rotation and humeral extension should be used to deliver the humeral head. A Darrach or Hohmann retractor at the posterior surface of the humeral head can be used as a skid to lever the head out of the joint. 6 Fractures 49. What are the critical factors in addressing 3 and 4-part proximal humeral fractures with a hemiarthroplasty? The critical factors to a successful outcome in 3 and 4-part proximal humeral fractures using hemiarthroplasty are: • Proper stem height • Proper stem retroversion • Proper tuberosities (lesser and greater tuberosity) repair • Joint stability Preoperative assessment of the proximal humeral comminution is critical to allow the surgeon to place the humeral component at the proper height. Comminution of the medial humeral neck should be assessed and pieces measured to help identify the position in which the humeral stem component must be placed.7 4-part fractures typically fracture at the humeral neck preserving the medial calcar, which is a good reference for height and version restoration when aligning with the medial aspect of the humeral stem component. The stem size is usually determined on preoperative radiographs and evaluated inatraoperatively with humeral trial broaches which best fit the canal. The largest stem which will allow adequate seating and stability and cementing is INTERNAL USE ONLY Dial In Frequently Asked Questions (FAQ) chosen. 8 An alternative method is to template the unaffected/uninjured humerus with a ruler to assist with determining proper length and restoration of proximal humeral anatomy. Version and height can be determined through trial reduction. Version is determined by flexing the elbow to 90° and the transverse epicondylar axis of the elbow to 0°. The arm is externally rotated to a point where the humeral head would point directly to the glenoid. This is usually between 30° and 45° of retroversion.9 A broach handle with alignment rod attachment can also assist with determining proper humeral stem component version. A sponge or lap pad can be placed around the broach trial or prosthesis and it can be impacted into the canal, allowing for enough stability to determine the appropriate height of the stem component prior to cementing.10 humeral stem is longer compared to the Turon. 52. Should I bring the RSP system as a back-up to Turon for 3 and 4-part proximal humeral fracture cases? Yes, for instances where cuff tear arthropathy or an irreparable rotator cuff is suspected and under the direction of the surgeon. Non absorbable sutures are placed at the bone tendon interface for retraction, reduction and repair. Alternatively, tuberosities can be pinned. Reduce the tuberosities to their near anatomic positions before cementing in the humeral stem component. Proper humeral head and stem component placement should allow A/P translation of approximately 50%, and when the arm is pulled down the humeral head should not fall below the midpoint of the glenoid.11 7-11 “Hemiarthroplasty for Complex Four-Part Fracture of the Proximal Humerus: Technical Considerations and Surgical Technique.” Dines et al, The University of Pennsylvania Orthopaedic Journal 15: 29-36, 2002. 50. Is there any dedicated fracture instrumentation for Turon? There currently is not any dedicated fracture instrumentation for Turon. However, there is dedicated fracture instrumentation through the Foundation Fracture System. 51. Can I use the Foundation Fracture trials with Turon for fracture cases? No. The Foundation Fracture trials are not compatible with the Turon humeral stems. The proximal body of the Foundation is larger and the distal INTERNAL USE ONLY 11 Dial In Chemical Composition of Turon Implants Chemical Composition of Turon Implants Shoulder Components Common Name Composition ASTM Spec Humeral Heads Cobalt Chrome CoCrMo F799/F1537 Humeral Necks Titanium Alloy Ti-6Al-V4 F136 Humeral Stems Titanium Alloy Ti-6Al-V4 F136 Glenoids Polyethylene UHMWPE F648 Porous Coating on Proximal Stem Radiographic Marker in Glenoids Unalloyed Commercially Pure Titanium CPTi F67 ASTM F136 — Titanium Alloy Chemical Requirements Element Composition, % (mass/mass) Nitrogen, max. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.05 Carbon, max. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.08 Hydrogen, max . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.012 A Iron, max. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.25 Oxygen, max. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.13 Aluminum. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5 —6.50 Vanadium. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5—4.5 TitaniumB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . balance 12 A Material 0.032 in. (0.813 mm) and under may have hydrogen content up to 0.0150%. B The percentage of titanium is determined by the difference and need not be determined or certified. INTERNAL USE ONLY Dial In Chemical Composition of Turon Implants ASTM F799/F1537 — Cobalt Chrome Chemical Composition Composition % (mass/mass) Alloy 1 UNS R31537 (Low Carbon) Element Alloy 2 UNS R31538 (High Carbon) Alloy3 UNS R31539 (Dispersion Strengthened) min max min max min max Carbon ...... 0.14 0.15 0.35 ...... 0.14 Aluminum ...... ...... ...... ...... 0.30 1.00 Lanthanum ...... ...... ...... ...... 0.03 0.20 Chromium 26.0 30.0 26.0 30.0 26.0 30.0 Molybdenum 5.0 7.0 5.0 7.0 5.0 7.0 Nickel ...... 1.0 ...... 1.0 ...... 1.0 Iron ...... 0.75 ...... 0.75 ...... 0.75 Silicon ...... 1.0 ...... 1.0 ...... 1.0 Manganese ...... 1.0 ...... 1.0 ...... 1.0 Nitrogen ...... 0.25 ...... 0.25 ...... 0.25 Cobalt A A Balance Balance Balance Approximately equal to the difference of 100% and the sum percentage of the other specified elements. The percentage of cobalt difference is not required to be reported. ASTM F648 — Polyethylene Requirements for UHMWPE Powders Property Test Method Resin Type Viscosity Number, mL/g, Elongation Stress, (Minimum)† Requirement Type 1 ASTM D4020 (0.02%) Type 2 Type 3 2000-3200 >3200 >3200 ASTM D4020 0.20 0.42 0.42 Ash, mg/kg, (Maximum) ISO3451-1 125 125 300 Extraneous Matter, No. Particles, (Maximum) 4.2.1 3 3 25 Titanium, mg/kg, (Maximum) 7.1.3.1 40 40 150 Aluminum, mg/kg, (Maximum) 7.1.3.1 20 20 100 Calcium, mg/kg, (Maximum) 7.1.3.1 5 5 50 Chlorine, mg/kg, (Maximum) 7.1.3.2 30 30 90 † Editorially corrected. INTERNAL USE ONLY 13 Dial In Chemical Composition of Turon Implants ASTM - Unalloyed Titanium TABLE 1 Chemical Requirements Composition, % (mass/mass) Grade 1 UNS R50250 Grade 2 UNS R50400 Grade 3 UNS R50550 Grade 4 UNS R50700 Nitrogen, max 0.03 0.03 0.05 0.05 Carbon, max 0.08 0.08 0.08 0.08 Hydrogen, maxB 0.015 0.015 0.015 0.015 Iron, max 0.20 0.30 0.30 0.50 Oxygen, max 0.18 0.25 0.35 0.40 balance balance balance balance Element Titanium A Forgings are designated Grade F-1, F-2, F-3, or F-4 respectively. Forging compositions are as specified in Table 1. B Maximum hydrogen content for billet is 0.0100 wt%. Key Dimensions PRIMARY HUMERAL STEMS 14 REVISION/LONG HUMERAL STEMS Cat. Number Size (mm) “A” Prosthesis Length (mm) “B” Stem Length (mm) Cat. Number Size (mm) “A” Prosthesis Length (mm) “B” Stem Length (mm) 520-01-006 6 115 77 520-01-106 6 200 162 520-01-008 8 114 71 520-01-108 8 199 156 520-01-010 10 113 65 520-01-110 10 198 150 520-01-012 12 112 59 520-01-112 12 197 144 520-01-014 14 111 52 520-01-114 14 196 137 520-01-016 16 110 45 520-01-116 16 195 130 INTERNAL USE ONLY Dial In Key Dimensions NEUTRAL HUMERAL HEADS Cat. Number Siz (mm) “A” Height (mm) “B” Spherical Diameter (mm) “C” Ø Inner Diameter (mm) “D” Spherical Offset (mm) “E” Skirt (mm) 520-38-014 38 x 14 14.0 19.0 31.4 7.6 2.6 520-38-018 38 x 18 18.0 19.0 33.6 3.7 2.6 520-42-016 42 x 16 16.0 21.0 35.7 7.6 2.6 520-42-020 42 x 20 20.0 21.0 37.6 3.7 2.6 520-46-016 46 x 16 16.0 23.0 38.4 9.7 2.6 520-46-020 46 x 20 20.0 23.0 41.0 5.7 2.6 520-46-024 46 x 24 24.0 23.0 42.0 1.7 2.6 520-50-018 50 x 18 18.0 25.0 42.7 9.7 2.6 520-50-022 50 x 22 22.0 25.0 45.1 5.6 2.6 520-50-026 50 x 26 26.0 25.0 45.9 1.7 2.6 520-54-018 54 x 18 18.0 27.0 45.4 11.7 2.6 520-54-022 54 x 22 22.0 27.0 48.3 7.6 2.6 520-54-026 54 x 26 26.0 27.0 49.7 3.7 2.6 INTERNAL USE ONLY 15 Dial In Key Dimensions OFFSET HUMERAL HEADS 16 Cat. Number Size (mm) “A” Height (mm) “B” Spherical Diameter (mm) “C” Ø Inner Diameter (mm) “D” Spherical Offset (mm) “E” Skirt (mm) “F” Offset (mm) 520-38-114 38 x 14 14.0 19.0 31.4 7.6 2.6 4.0 520-42-116 38 x 18 18.0 19.0 33.6 3.7 2.6 4.0 520-42-120 42 x 16 16.0 21.0 35.7 7.6 2.6 4.0 520-46-116 42 x 20 20.0 21.0 37.6 3.7 2.6 4.0 520-46-120 46 x 16 16.0 23.0 38.4 9.7 2.6 4.0 520-46-124 46 x 20 20.0 23.0 41.0 5.7 2.6 4.0 520-50-118 46 x 24 24.0 23.0 42.0 1.7 2.6 4.0 520-50-122 50 x 18 18.0 25.0 42.7 9.7 2.6 4.0 520-50-126 50 x 22 22.0 25.0 45.1 5.6 2.6 4.0 520-54-118 50 x 26 26.0 25.0 45.9 1.7 2.6 4.0 520-54-122 54 x 18 18.0 27.0 45.4 11.7 2.6 4.0 520-54-126 54 x 22 22.0 27.0 48.3 7.6 2.6 4.0 INTERNAL USE ONLY Dial In Key Dimensions KEELED GLENOIDS Cat. Number Size (mm) “A” Length (mm) “B” Width (mm) “C” Thickness (mm) “D” Keel Width (mm) “E” Keel Length (mm) 520-01-138 38 29.7 23.9 4.2 3.8 12.8 520-01-142 42 32.3 25.4 4.2 3.8 12.8 520-01-146 46 34.8 26.9 4.2 3.8 12.8 520-01-150 50 37.3 28.4 4.2 3.8 12.8 520-01-154 54 39.9 30.0 4.2 3.8 12.8 PEGGED GLENOIDS Cat. Number Size (mm) “A”Length (mm) “B”Width (mm) “C” Thickness (mm) “D” Center Peg Length (mm) “E” Δ Between Center Peg and Superior Peg (mm) “F” Δ Between Center Peg and Inferior Pegs (mm) 520-01-238 38 29.7 23.9 4.2 15.0 3.2 7.4 520-01-242 42 32.3 25.4 4.2 15.0 3.2 5.3 520-01-246 46 34.8 26.9 4.2 15.0 3.2 5.3 520-01-250 50 37.3 28.4 4.2 15.0 3.2 5.3 520-01-254 54 39.9 30.0 4.2 15.0 3.2 5.3 INTERNAL USE ONLY 17 TM DJO Surgical I A DJO Global Company T 800.456.8696 D 512.832.9500 F 512.834.6300 9800 Metric Blvd. I Austin, TX 78758 I U.S.A. djosurgical.com ©2011 Encore Medical, L.P. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. See package insert for a complete listing of indications, contraindications, warnings, and precautions. 0031106-002 Rev A 01/12
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xmp.iid:37BD9705912268118083C462A15BC194, xmp.iid:1D394B6DD02168118083B3C238F966A3, xmp.iid:55CC1828D12168118083B3C238F966A3, xmp.iid:01F63E98592268118083B3C238F966A3, xmp.iid:CBAB34CF642268118083B3C238F966A3, xmp.iid:925D3071002368118083DC5BB4948142 History When : 2011:03:29 20:24:30-07:00, 2011:03:29 20:31:49-07:00, 2011:03:29 20:31:49-07:00, 2011:03:29 20:32:38-07:00, 2011:03:29 20:36:57-07:00, 2011:03:29 20:43:24-07:00, 2011:03:29 20:49:03-07:00, 2011:03:29 20:53:05-07:00, 2011:03:29 20:57:45-07:00, 2011:03:29 21:21:11-07:00, 2011:03:29 21:23:38-07:00, 2011:03:29 21:24:18-07:00, 2011:03:29 21:25-07:00, 2011:03:29 21:26:34-07:00, 2011:03:29 21:34:55-07:00, 2011:03:29 21:40:48-07:00, 2011:03:29 21:58:48-07:00, 2011:03:29 22:03:43-07:00, 2011:03:29 22:06:53-07:00, 2011:03:29 22:11:49-07:00, 2011:03:29 22:19:59-07:00, 2011:03:29 22:27:11-07:00, 2011:03:29 22:30:25-07:00, 2011:03:29 22:49:56-07:00, 2011:03:29 22:53:40-07:00, 2011:03:29 23:00:50-07:00, 2011:03:29 23:01:35-07:00, 2011:03:29 23:02:17-07:00, 2011:03:29 23:03:02-07:00, 2011:03:29 23:04:09-07:00, 2011:03:29 23:06:42-07:00, 2011:03:29 23:12:46-07:00, 2011:03:29 23:13:02-07:00, 2011:03:29 23:15:17-07:00, 2011:03:29 23:16:31-07:00, 2011:03:29 23:16:53-07:00, 2011:03:29 23:21:20-07:00, 2011:03:29 23:26:40-07:00, 2011:03:29 23:28:05-07:00, 2011:03:29 23:34:03-07:00, 2011:03:29 23:35:39-07:00, 2011:03:29 23:36:43-07:00, 2011:03:29 23:36:43-07:00, 2011:03:29 23:38:49-07:00, 2011:03:29 23:44:47-07:00, 2011:03:29 23:47:09-07:00, 2011:03:29 23:49:43-07:00, 2011:03:29 23:51:10-07:00, 2011:03:29 23:54:05-07:00, 2011:03:29 23:56:08-07:00, 2011:03:29 23:57:57-07:00, 2011:03:30 00:07:46-07:00, 2011:03:30 00:09:52-07:00, 2011:03:30 00:10:38-07:00, 2011:04:01 15:51:29-07:00, 2011:04:01 15:56:13-07:00, 2011:04:01 16:08:27-07:00, 2011:04:01 16:26:54-07:00, 2011:04:01 16:33:18-07:00, 2011:04:01 16:37:45-07:00, 2011:04:01 16:43:36-07:00, 2011:04:01 16:45:39-07:00, 2011:04:01 16:45:39-07:00, 2011:04:01 16:49:45-07:00, 2011:04:01 16:50:15-07:00, 2011:04:01 16:59:55-07:00, 2011:04:01 17:01:40-07:00, 2011:04:06 13:19:49-05:00, 2011:04:06 13:19:49-05:00, 2011:04:06 14:00:32-05:00, 2011:04:06 14:15:43-05:00, 2011:04:06 14:17:35-05:00, 2011:04:06 14:19:11-05:00, 2011:04:06 15:06:47-05:00, 2011:04:06 15:20:25-05:00, 2011:04:07 10:28:41-05:00, 2011:04:07 10:32:43-05:00, 2011:04:07 10:33:27-05:00, 2011:04:07 11:34:50-05:00, 2011:04:07 11:37:19-05:00, 2011:04:07 11:40:58-05:00, 2011:04:07 11:40:58-05:00, 2011:04:07 11:46:22-05:00, 2011:04:07 11:46:52-05:00, 2011:04:20 15:13:38-05:00, 2011:04:20 15:18:55-05:00, 2011:04:21 14:14:18-05:00, 2011:04:25 11:21:35-05:00, 2011:04:25 11:22:10-05:00, 2011:04:27 14:58:55-05:00, 2011:05:03 11:54:53-05:00, 2011:05:03 14:15:30-05:00, 2011:05:03 14:16:19-05:00, 2011:05:04 10:10:57-05:00, 2011:05:04 10:23:27-05:00, 2011:05:10 11:46:15-05:00, 2011:05:10 11:48:49-05:00, 2011:05:10 12:30:45-05:00, 2011:05:10 13:43:02-05:00, 2011:05:10 14:49:02-05:00, 2011:05:12 14:07:10-05:00, 2011:05:12 14:07:11-05:00, 2011:05:25 15:58:20-05:00, 2011:06:27 10:14:03-05:00, 2011:06:29 14:32:43-05:00, 2011:06:29 14:32:43-05:00, 2011:06:30 11:53:31-05:00, 2011:06:30 13:24:21-05:00, 2011:07:07 19:01:16-05:00, 2011:07:07 19:01:16-05:00, 2011:07:09 13:28:55-05:00, 2011:07:09 13:38:42-05:00, 2011:07:09 13:43:38-05:00, 2011:07:09 14:25:34-05:00, 2011:07:09 14:43:09-05:00, 2011:07:09 14:51:36-05:00, 2011:07:09 14:52:11-05:00, 2011:07:09 14:58:28-05:00, 2011:07:09 15:02:45-05:00, 2011:07:09 15:07:10-05:00, 2011:07:09 15:15:10-05:00, 2011:07:09 15:20:19-05:00, 2011:07:10 12:22:51-05:00, 2011:07:10 12:24:20-05:00, 2011:07:10 12:26:32-05:00, 2011:07:10 12:29:10-05:00, 2011:07:12 19:44:25-05:00, 2011:07:12 20:37:02-05:00, 2011:07:12 20:39:59-05:00, 2011:07:12 23:43:29-05:00, 2011:07:12 23:43:47-05:00, 2011:07:12 23:45:27-05:00, 2011:07:13 12:11:07-05:00, 2011:08:24 19:02:13-05:00, 2011:08:24 19:12:24-05:00, 2011:08:24 19:26:06-05:00, 2011:08:24 19:31:26-05:00, 2011:08:24 19:34:22-05:00, 2011:08:24 19:38:46-05:00, 2011:08:25 19:48:01-05:00, 2011:08:25 19:49:41-05:00, 2011:08:25 19:50:42-05:00, 2011:08:25 20:15:24-05:00, 2011:08:25 20:16:30-05:00, 2011:08:25 20:29:56-05:00, 2011:08:25 20:53:01-05:00, 2011:08:25 21:03:19-05:00, 2011:08:25 22:51:49-05:00, 2011:08:25 22:52:14-05:00, 2011:08:25 23:32:47-05:00, 2011:08:25 23:37:03-05:00, 2011:08:25 23:46:22-05:00, 2011:08:25 23:53:55-05:00, 2011:08:25 23:54:18-05:00, 2011:08:25 23:58:07-05:00, 2011:08:26 00:01:44-05:00, 2011:08:26 00:05:04-05:00, 2011:08:26 00:06:52-05:00, 2011:08:26 00:08:39-05:00, 2011:08:26 00:11:02-05:00, 2011:08:26 00:17:42-05:00, 2011:08:26 00:21:07-05:00, 2011:08:26 00:23:18-05:00, 2011:08:26 00:29:02-05:00, 2011:08:26 00:29:50-05:00, 2011:08:26 00:32:30-05:00, 2011:08:26 00:32:59-05:00, 2011:08:29 11:38:40-05:00, 2011:08:29 11:49:56-05:00, 2011:08:29 12:02:41-05:00, 2011:08:29 12:03:29-05:00, 2011:08:29 12:08:44-05:00, 2011:08:29 12:12:24-05:00, 2011:08:29 12:16:16-05:00, 2011:08:29 12:17:14-05:00, 2011:09:13 10:02:33-05:00, 2011:09:13 10:06:34-05:00, 2011:09:13 10:06:57-05:00, 2011:09:13 10:10:11-05:00, 2011:09:13 10:11:52-05:00, 2011:09:13 13:15:49-05:00, 2011:09:13 13:19:06-05:00, 2011:09:13 13:20:25-05:00, 2011:09:22 11:18:36-05:00, 2011:09:22 11:20:06-05:00, 2011:12:19 21:35:01-06:00, 2011:12:19 21:36:39-06:00, 2011:12:19 21:37:11-06:00, 2011:12:19 21:37:11-06:00, 2011:12:20 18:05:16-06:00, 2011:12:21 12:14-06:00, 2011:12:21 12:14:26-06:00, 2011:12:27 10:16:44-05:00, 2011:12:27 10:16:44-05:00, 2011:12:27 10:19:10-05:00, 2011:12:27 10:21:28-05:00, 2011:12:27 11:12:46-05:00, 2011:12:27 11:28:06-05:00, 2011:12:27 11:40:44-05:00, 2011:12:27 21:27:45-05:00, 2011:12:28 14:40:06-05:00, 2011:12:28 14:55:48-05:00, 2011:12:28 14:59:51-05:00, 2011:12:28 15:10:29-05:00, 2011:12:28 16:02:26-05:00, 2011:12:28 16:04:12-05:00, 2011:12:28 16:38:51-05:00, 2012:01:06 14:40:45-06:00, 2012:01:06 14:53:21-06:00, 2012:01:06 15:03:05-06:00, 2012:01:06 16:06:11-06:00, 2012:01:16 10:40:05-06:00, 2012:01:16 10:41:56-06:00, 2012:01:16 10:41:56-06:00, 2012:01:18 10:52:33-05:00, 2012:01:19 07:38:06-05:00, 2012:01:19 07:38:06-05:00, 2012:01:19 12:18:52-05:00, 2012:01:19 12:44:38-05:00, 2012:01:19 13:58:45-05:00, 2012:01:19 15:44:40-05:00, 2012:01:19 16:18:57-06:00, 2012:01:19 16:21:26-06:00, 2012:01:19 16:23:31-06:00, 2012:05:29 12:41:49-04:00, 2012:05:29 12:42:01-04:00, 2012:05:29 12:42:01-04:00, 2012:05:29 10:59:25-07:00, 2012:05:29 10:59:26-07:00, 2012:05:29 11:31:57-07:00, 2012:05:29 15:05:03-07:00, 2012:05:29 15:14:45-07:00, 2012:05:29 15:17:08-07:00, 2012:05:29 15:18:46-07:00, 2012:05:29 17:27:18-07:00, 2012:05:30 10:59:23-07:00, 2012:05:30 11:28:16-07:00, 2012:05:30 14:38:25-07:00, 2012:05:30 14:42:43-07:00, 2012:05:30 14:48:01-07:00, 2012:05:30 15:05:30-07:00, 2012:05:30 15:49:19-07:00, 2012:05:30 16:45:54-07:00, 2012:05:30 16:52:38-07:00, 2012:05:30 16:57:38-07:00, 2012:05:30 17:00:30-07:00, 2012:05:30 17:27:33-07:00, 2012:05:31 15:47:40-07:00, 2012:05:31 16:34:50-07:00, 2012:05:31 17:00:36-07:00, 2012:05:31 17:32:37-07:00, 2012:06:01 10:58:13-07:00, 2012:06:01 11:44:48-07:00, 2012:06:01 14:31:53-07:00, 2012:06:01 14:34:21-07:00, 2012:06:01 14:51:28-07:00, 2012:06:01 14:59:42-07:00, 2012:06:01 15:07:50-07:00, 2012:06:01 15:14:35-07:00, 2012:06:01 15:18:31-07:00, 2012:06:21 16:46:32-07:00, 2012:06:21 16:51:45-07:00, 2012:06:22 09:08:28-07:00, 2012:06:22 10:28:45-07:00, 2012:06:29 09:53:58-07:00 History Software Agent : Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, Adobe InDesign 7.0, 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