Hip System. Surgical Protocol

Transcription

1 U2 TM Hip System Surgical Protocol

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3 Table of Contents Product Review... 1 Surgical Protocol 0. Preoperative Planning Osteotomy of the Femoral Neck Acetabular Preparation Acetabular Cup Size Determination Acetabular Cup Insertion Screw Insertion Femoral Preparation Calcar Planning (Optional) Trial Reduction Acetabular Cup Liner Insertion Femoral Stem Insertion Femoral Head Assembly Ordering information Implant - U2 Femoral Stem System U2 Acetabular Cup System U2 Acetabular Cup Liner Femoral Head Accessory Acetabular Screw Trial - Femoral Head Trial Liner Trial Cup Trial Instrument Catalog Safety Statements... 33

4 Product Review United U2 Hip System is indicated for primary total hip arthroplasty. There are five femoral stem options, and that should be chosen by surgeons determination. All types of stems share the same set of instruments with a variety of standard surgical approaches. U2 Hip Stem options include: HA+Ti Plasma Spray Stem Matrix Porous Stem Ti Porous Coated Stem Press-fit Stem Cemented Stem HA+Ti Plasma Spray Matrix Porous Ti Porous Coated Press-fit Cemented 1

5 Normal, stovepipe, and champagne-flute are three femoral canal types that characterized by the canal flare index. The potential for mismatching in the shape of the bone and the implant should be minimized to prevent excessive micromotion and loosening. Therefore, a close geometric fit and fill between proximal and distal is essential as designing press-fit total hip implants. United U2 HA+Ti Plasma Spray Stem features 14 sizes to cope with different canal shapes. By applying the matrix concept, a distal size of U2 HA+Ti Plasma Stem shares up to three proximal sizes; contrariwise, a proximal stem size shares up to three distal sizes. U2 HA size Matrix Concept Proximal diameter Distal diameter 2

6 The U2 Acetabular Cup System is also available in four options: HA+Ti Plasma Spray Cup Ti Porous Coated Cup Ti Plasma Spray Cup Multi-hole Cup Sizes of cups are in 2 mm increment and collocation of highly cross-linked polyethylene liners (XPE Liner). Large diameter femoral heads are also available, which can further improve the performance in range of motion (ROM) and joint stability. HA+Ti Plasma Spray Cup Ti Porous Coated Cup Ti Plasma Spray Cup Multi-hole Cup 3

7 0. Preoperative Planning Preoperative planning is essential for achieving the optimal total hip arthroplasty. Choosing the appropriate sizes and position of the femoral component would be ultimately necessary. Making an accurate femoral component selection begins with the thorough radiographic views of the involved femur: an A/P view and M/L view. For the A/P view, have the pelvis centered at the pubic symphysis. In addition, both views require at least 20 cm of the proximal femur. These radiographies should be analyzed by using the templates to determine the correct leg length, femoral offset, center of rotation of the hip joint and the implant size. The U2 Hip standard 110 % and 115 % magnification templates are provided. +10mm +7.5mm +5mm +2.5mm +0mm -3mm ø 8 mm 4

8 Special Order Items 1. Osteotomy of the Femoral Neck 1. Osteotomy Guide , # , # , #2-7 Once the joint has been dislocated, align the Osteotomy Guide 1 with the central line of the femur shaft. Vary the level of the reference hole on the top of the Osteotomy Guide 1 until it is at the same with the femoral head center, or use the pit, which below the reference hole match the piriformis fossa to determine the cut. To inscribe the femoral neck resection line with electrocautery if necessary. Completing the femoral neck resection with the power saw. Mark the cutting line with electrocautery and resect the femoral neck with the power saw. 5

9 2. Acetabular Preparation Special Order Items Attach the Cup Reamer 2 to the Cup Reamer Handle 3. Start acetabular reaming with the smallest cup reamer, and gradually enlarge the reamer in 2 mm increment. Complete the reaming process after the exposition of the bleeding cancellous bone. 2. Cup Reamer Cup Reamer Handle RA 3. Acetabular Cup Size Determination The United Acetabular Cup sizes range from 44 mm to 70 mm in 2 mm increment. Proper attention must be given to evaluate bone quality and to determine the appropriate implant size. Under-reaming of the acetabulum is recommended for normal bone quality. Likewise, hard/dense bone will accommodate a line to line. 6

10 4. Acetabular Cup Insertion 4. Alignment Tower, lateral Cup Impactor RD Attach the quick connect Alignment Tower 4 to the Cup Impactor 5 and thread the Alignment Rod 6 into left/right screw hole of the tower. Firmly secure the real cup onto the tip of the cup impactor. As the patient in lateral side position, make the vertical bar perpendicular to the operating table with the alignment rod parallel to the floor. The cup impactor subsequently be rotated until the alignment rod is in line with the longitudinal axis of the patient body. Then, an anatomic positioning of 45 abduction and 20 anteversion is built up Alignment Rod To avoid possible neurologic and vascular impairments, the cup implant should be positioned to allow screw placement in posterior superior and/or posterior inferior quadrants. Posterior/Superior Anterior/Superior Posterior/Inferior 7 Anterior/Inferior

11 5. Screw Insertion After the screw location has been determined, position the Drill Guide 7 into the cup and drill the selected holes using either a Flexible Drill 8, or Straight Drill 9. Remove the sleeve from the drill prior applying. 7. Drill Guide RB 8. Flexible Drill RA RA 9. Straight Drill Depth Gauge RA Once drilling is completed, use the Depth Gauge 10 to determine the appropriate length of screw. Grasp the screw head with the Screw Forceps 11 and utilize a Ratcheting Screwdriver 12, 13, 14 to inset it into the selected hole. 11. Screw Forceps Screw Driver, Straight Universal Screw Driver Ratcheting Handle

12 Special Order Items 6. Femoral Preparation 15. Femoral Cutting Chisel Position the Femoral Cutting Chisel 15 laterally toward the greater trochanter to remove a piece of the medial portion. The opening will provide an adequate entry point complementing the patient s anatomy for the reamer and broach. 16. T-Handle Stem Reamer Broach Handle RA 18. U2 Broach RC RC RC RC RC RC RC RC If the surgeon chose the U2 HA+Ti plasma spray stem which with Matrix design, it is recommended to employ the Ream-Broach-Ream technique. Once a piece of cancellous bone is removed, use the T-Handle Stem Reamer 16 manually to enlarge the medullar canal. As inserting the stem reamer, be sure that the grip handle is perpendicular to the canal. After proper distal diameter is obtained by using the T-Handle Stem Reamer 16, attach the smallest U2 Broach 18 to the Broach Handle 17 and gradually enlarge the broach until it reaches to the optimal proximal press-fit size. Slightly enlarge the canal by using the U2 Stem Reamer 19 if there is any inference while broaching. U2 Broach Size Distal Diameter #0 Ø8 #1 Ø9 #2 Ø10 #3 Ø10 #4 Ø11 #5 Ø12 #6 Ø13 #7 Ø15 9

13 6. Femoral Preparation Special Order Items Once the proximal size is determined, employ U2 Stem Reamer 19 and ream the canal to the most advantageous diameter that corresponds with the decided proximal size. Reaming range should not be in excess of the cortical bone contact. 19. U2 Stem Reamer HA + Ti Plasma Spray Stem Proximal Size Available Distal Diameter #0 Ø8 #1 Ø9 #2 Ø10, Ø11 #3 Ø10, Ø11, Ø12 #4 Ø11, Ø12 #5 Ø12, Ø13 #6 Ø13, Ø14 #7 Ø15 If Ti Porous Coated Stem, Press fit Stem, or Cemented Stem is chosen, Ream-Broach-Ream technique would not be necessary. After the femoral canal has been opened, connect the U2 Stem Reamer 19 to the power device and create appropriate distal implant diameter. Sequential femoral reaming begins with the smallest reamer and gradually enlarges. U2 Stem Reamer provided in 1 mm increments. Reaming should continue until cortical bone is achieved and desired diameter is met. Once the canal is reamed, begin with the broach of the smallest size until the size leaves an approximately 2-4 mm of distance from the stop point of the broach to the medial wall of the femur shaft. 10

14 7. Calcar Planning (Optional) 20. Calcar Reamer For cemented implants, after the final broach is seated, place the Calcar Reamer 20 to the broach trunnion and plane the femoral neck until it reaches the appropriate surface with the collar of the Cemented stem. 11

15 8. Trial Reduction Special Order Items Assemble the final broach with the corresponded Neck Trial 21, and place the XPE Cup Liner Trial 22 to the final cup implant. Then perform a trial reduction by adjusting the Femoral Head Trial 23 which available in numerous neck lengths to satisfy the leg length, offset, range of motion and stability. U2 Hip System has provided surgeons with the Size Plate 24, which may serve as a reference to determine the exact head size, so that the head size can correspond to the size of the chosen cup. 21. Neck Trial RB RB RB RB RB Cup Size (mm) 44, 46, 48 50, 52 54, 56, 58, 60, 62, 64, 66, 68, 70 Head Size (mm) XPE Cup Liner Trial, 10 C/N varies by size 23. Femoral Head Trial C/N varies by size Metal delta Ceramic 24. Size Plate, XPE Hip

16 9. Acetabular Cup Liner Insertion 25. Universal Handle , 230 mm Clean and dry the cup with the sterile cloth before inserting the selected liner. For proper seating and locking of the liner, the insert must be in an appropriate orientation and be sure the location of the 10 lip matches that of the trial insert. Once implant insert is aligned, assemble the Universal Handle 25 with the Liner Impactor 26 that corresponds to the implant size. Then impact the implant gently to the proper seating. 26. Liner Impactor

17 10. Femoral Stem Insertion After trial reduction, remove the broach and introduce the stem implant by using the stem holder. UOC offers an handy U2 Stem Quick Connect Holder 27 for stem insertion. Use the holder to firmly attach the stem to the inserting hole on the stem shoulder. Gently tap the holder to achieve initial stem implantation into medullary canal. Care should be taken to orient the stem with proper alignment and version during implant impaction. Note: Stop tapping the holder if the stem holder impinges with greater trochanter. Apply the Stem Impactor 28 to the implant and begin to tap the handle with a mallet until the implant is properly positioned. Ensure the impacting is in the central axis of the femur. 27. U2 Stem Quick Connect Holder Stem Impactor, Long RA 14

18 11. Femoral Head Assembly 25. Universal Handle , 140 mm Following the stem insertion, clean and dry the taper of the femoral stem. Place the selected femoral head onto the taper and lightly tap using the Universal Handle 25 which attached with the appropriate Femoral Head Impactor Femoral Head Impactor RA 15

19 to Orthopedics

20 U2 Femoral Stem System Special Order Items HA+Ti Plasma Spray Catalog No. Size #0 ø #1 ø #2 ø #3 ø #2 ø #3 ø #4 ø #3 ø #4 ø #5 ø #5 ø #6 ø #6 ø #7 ø 15 Matrix Porous Catalog No. Size #1 ø #2 ø #3 ø #2 ø #3 ø #4 ø #3 ø #4 ø #5 ø #5 ø #6 ø #6 ø #7 ø 15 Ti Porous Coated Catalog No. Size #1 ø #2 ø #3 ø #4 ø #5 ø #6 ø #7 ø 15 Cemented Catalog No. Size #2 ø #3 ø #4 ø #5 ø #6 ø 14 Press-fit Catalog No. Size #1 ø #2 ø #3 ø #4 ø #5 ø #6 ø 14

21 U2 Acetabular Cup System Special Order Items Full PE Cemented ø 44 mm ø 46 mm ø 48 mm ø 50 mm ø 52 mm ø 54 mm ø 56 mm ø 58 mm ø 60 mm ø 62 mm Multi-hole ø 44 mm ø 46 mm ø 48 mm ø 50 mm ø 52 mm ø 54 mm ø 56 mm ø 58 mm ø 60 mm ø 62 mm ø 64 mm ø 66 mm ø 68 mm ø 70 mm HA+Ti Plasma Spray ø 44 mm ø 46 mm ø 48 mm ø 50 mm ø 52 mm ø 54 mm ø 56 mm ø 58 mm ø 60 mm ø 62 mm ø 64 mm ø 66 mm ø 68 mm ø 70 mm 18

22 U2 Acetabular Cup System Special Order Items Ti Porous Coated ø 44 mm ø 46 mm ø 48 mm ø 50 mm ø 52 mm ø 54 mm ø 56 mm ø 58 mm ø 60 mm ø 62 mm ø 64 mm ø 66 mm ø 68 mm ø 70 mm Ti Plasma Spray Cup ø 44 mm ø 46 mm ø 48 mm ø 50 mm ø 52 mm ø 54 mm ø 56 mm ø 58 mm ø 60 mm ø 62 mm ø 64 mm ø 66 mm ø 68 mm ø 70 mm 19

23 U2 Acetabular Cup Liner Special Order Items XPE Cup Liner, 10º Head Size ø 44 mm ø 46 mm ø 48 mm 28 mm ø 50 mm ø 52 mm 32 mm ø 54 mm ø 56 mm ø 58 mm ø 60 mm ø 62 mm ø 64 mm ø 66 mm ø 68 mm ø 70 mm 36 mm XPE Cup Liner, 0º Head Size ø 44 mm ø 46 mm ø 48 mm 28 mm ø 50 mm ø 52 mm 32 mm ø 54 mm ø 56 mm ø 58 mm ø 60 mm ø 62 mm ø 64 mm ø 66 mm ø 68 mm ø 70 mm 36 mm 20

24 Femoral Head CoCrMo Head Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø delta Ceramic Head Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø Ø

25 Accessory Special Order Items Cup Plug PE Plug Set C PMMA Plug Set Cement Stopper ø 8 mm ø 10 mm ø 12 mm ø 14 mm ø 16 mm Acetabular Screw Ti Cancellous Bone Screw mm mm mm mm mm mm mm mm 22

26 Femoral Head Trial Femoral Head Trial RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø delta Ceramic Head Trial RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø RB Ø

27 Liner Trial Special Order Items XPE Cup Liner Trial, 10 Head Size ø 44 mm ø 46 mm ø 48 mm ø 50 mm ø 52 mm ø 54 mm ø 56 mm ø 58 mm ø 60 mm ø 62 mm ø 64 mm ø 66 mm ø 68 mm ø 70 mm 28 mm 32 mm 36 mm XPE Cup Liner Trial, 0 Head Size ø 44 mm ø 46 mm ø 48 mm ø 50 mm ø 52 mm ø 54 mm ø 56 mm ø 58 mm ø 60 mm ø 62 mm ø 64 mm ø 66 mm ø 68 mm ø 70 mm 28 mm 32 mm 36 mm 24

28 Cup Trial Cup Trial ø 44 mm ø 46 mm ø 48 mm ø 50 mm ø 52 mm ø 54 mm ø 56 mm ø 58 mm ø 60 mm ø 62 mm ø 64 mm ø 66 mm ø 68 mm ø 70 mm 25

29 Instrument Catalog Femoral Cutting Chisel Femoral Head Extractor T-Handle Stem Reamer Full PE Cement Restrictor Inserter RA Stem Extractor RA Stem Impactor U2 Stem Quick Connect Holder 26

30 Instrument Catalog Special Order Items Osteotomy Guide #0 Osteotomy Guide #1 Osteotomy Guide #2~ U2 Stem Reamer U2 Stem Reamer U2 Stem Reamer U2 Stem Reamer U2 Stem Reamer U2 Stem Reamer U2 Stem Reamer U2 Stem Reamer 8 mm 9 mm 10 mm 11 mm 12 mm 13 mm 14 mm 15 mm Calcar Reamer 40 mm RB RB RB RB RB Neck Trial #0 Neck Trial #1, #2 Neck Trial #3, #4 Neck Trial #5 Neck Trial #6, # RC RC RC RC RC RC RC RC U2 Broach #0 U2 Broach #1 U2 Broach #2 U2 Broach #3 U2 Broach #4 U2 Broach #5 U2 Broach #6 U2 Broach # RA Broach Handle 27

31 Instrument Catalog U2 Hip Basic Case U2 Hip Stem Case Acetabular Case RA Femoral Head Remover Hammer Slide Rod RB Drill Guide Straight Drill Cup Liner Extractor 28

32 Instrument Catalog Special Order Items RA Depth Gauge Full PE Acetabular Cup Locator, 26 mm, 20º Hooded RA Cup Reamer Handle Cup Reamer ø 42 mm Cup Reamer ø 44 mm Cup Reamer ø 46mm Cup Reamer ø 48 mm Cup Reamer ø 50 mm Cup Reamer ø 52 mm Cup Reamer ø 54 mm Cup Reamer ø 56 mm Cup Reamer ø 58 mm Cup Reamer ø 60 mm Cup Reamer ø 62 mm Cup Reamer ø 64 mm Cup Reamer ø 66 mm Cup Reamer ø 68 mm Cup Reamer ø 70 mm RA RA RA RA Flexible Drill Short 15 mm Flexible Drill Long 25 mm Flexible Drill Long 35 mm Flexible Drill Long 50 mm 29

33 Instrument Catalog Special Order Items RA Femoral Head Impactor 26 mm Size Plate, XPE Hip RD Cup Impactor Universal Handle 140 mm Universal Handle 230 mm Straight screw driver Universal Screw Driver Liner Impactor 28 mm Liner Impactor 32 mm Liner Impactor 36 mm Alignment tower, lateral 30

34 Instrument Catalog Alignment Rod Screw Forceps T-Handle Caliper Ratcheting Handle 31

35 to Orthopedics

36 Safety Statements - U2 Hip Stem DESCRIPTION UNITED U2 Hip System include the femoral stems, all-polyethylene cemented or cementless acetabular components, metal backed acetabular component, bipolar prostheses, and femoral head components. It is available in an array of styles and matrixed sizes to accommodate various hip surgical requirements. The femoral stems are available in four surface structure styles such as grit blasted, Ti plasma spray, Ti plasma spray with Hydroxylapatite surface treatment and sintered Ti bead porous coated. The grit blasted stems are intended to be fixed only with the use of PMMA bone cement. The femoral stem prosthesis may be used in conjunction with an Head as a bipolar hip replacement or another acetabular component for total hip arthroplasty. MATERIALS ASTM F-620 Titanium 6Al-4V ELI alloy ASTM F-136 Ti Ally ASTM F-67 CP Titanium ASTM F-1185 Hydroxylapatite ASTM F-1580 CPTi bead ASTM F-75 Co-Cr-Mo alloy ASTM F-75 Co-Cr-Mo alloy ASTM F-1537 Co-Cr-Mo alloy ISO 5834 UHMWP Femoral stem, Revision hip stem Acetabular Cup Plasma spray coating Plasma spray coating Porous coating Femoral stem (for cement) Porous coating Screw Cup Insert INDICATIONS For use as a Bipolar Hip Replacement 1. Femoral head/neck factures or non-unions. 2. Aseptic necrosis of the femoral head. 3. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. For use as a Total Hip Replacement 1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. 2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. 3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. CONTRAINDICATIONS 1. Any active or suspected latent infection in or about the hip joint 2. Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. 3. Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis. 4. Skeletal immaturity. 5. Obesity. An overweight or obese patient can produce loads on the prosthesis which can lead to failure of the fixation of the device or to failure of the device itself. 6. For use as a Bipolar Hip Replacement, pathological conditions of the acetabulum which would prevent achieving adequate range of motion, appropriate head stability, and/or a well-seated and supported smooth acetabular articulation of the head. POSSIBLE ADVERSE EFFECT 1. While the expected life of total hip replacement components is difficult to estimate, it is finite. These components are made of foreign materials placed within the body for the potential restoration of mobility or reduction of pain. However, due to the many biological, mechanical and physicochemical factors, which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone. 2. Dislocation of the hip prosthesis can occur due to inappropriate patient activity, trauma or other biomechanical considerations. 3. Loosening of total hip components can occur. Early mechanical loosening may result from inadequate initial fixation, latent infection, premature loading of the prosthesis or trauma. Late loosening may result from trauma, infection, biological complications, including osteolysis, or mechanical problems, with the subsequent possibility of bone erosion and/or pain. 4. Fatigue fracture of femoral stems and/or fracture of ceramic heads occurred in a small percentage of cases. Stem/head fracture is more likely to occur in the heavy, physically active individual or when contralateral joint disability results in a disproportionate distribution of weight on the reconstructed joint. 5. Peripheral neuropathies, nerve damage, circulatory compromise and heterotopic bone formation may occur. 6. Serious complications may be associated with any total joint replacement surgery. These complications include, but are not limited to: genitourinary disorders; gastrointestinal disorders; vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; myocardial infarction or death. 7. Acetabular pain may occur after acetabular replacement due to loosening of the implant, or after bipolar hip arthroplasty due to localized pressure associated with incongruities of fit or tissue inflammation. 8. Intraoperative fissure, fracture, or perforation of the femur, acetabulum or trochanter can occur due to impaction of the component into the prepared femoral canal or acetabulum. Postoperative femoral or acetabular fracture can occur due to trauma, the presence of defects, or poor bone stock. Metal sensitivity reactions have been reported following joint replacement 33

37 9. Adverse effects may necessitate reoperation, revision, arthrodesis of the involved joint, Girdlestone and/or amputation of the limb. (UHMWPE) and/or ceramic. Particulate is generated by interaction between components, as well as between components and bone, primarily through wear mechanisms of adhesion, abrasion and fatigue. Secondarily, particulate can also be generated by third- body wear. Osteolysis can lead to future complications, including loosening, necessitating the removal and replacement of prosthetic components. 10. With all implant devices, asymptomatic, localized progressive bone resorption (osteolysis) may occur around the prosthetic components as a consequence of foreign-body reaction to the particulate matter of cement, metal, ultra-high molecular weight polyethylene (UHMWPE) and/or ceramic. Particulate is generated by interaction between components, as well as between components and bone, primarily through wear mechanisms of adhesion, abrasion and fatigue. Secondarily, particulate can also be generated by third- body wear. Osteolysis can lead to future complications, including loosening, necessitating the removal and replacement of prosthetic components. WARNINGS 1. Discard all damaged or mishandled implants. 2. Never reuse an implant, even though it may appear undamaged. 3. Polished bearing areas and machined taper surfaces must not come in contact with hard or abrasive surfaces. 4. Bearing areas must always -be clean and free of debris prior to assembly. 5. At time of assembly, machined taper surfaces must be clean and dry to ensure proper seating and assembly security. 6. Improper seating of the head or Endo neck extension may result in a discrepancy in neck length, component disassociation and/or dislocation. 7. Handling of the hydroxylapatite treated regions must be avoided as it may compromise the effectiveness of the device. 8. Contouring or bending of an implant may reduce its fatigue strength and cause failure under load. 9. Infra-operative preparation and implantation of a femoral stem component can result in cracks of the proximal femur. The application of prophylactic cerclage wiring to the proximal femur may aid in the prevention of femoral cracks, crack propagation or their displacement. 10. Care should be taken not to cut through surgical gloves when handling any sharp-edged orthopedic device. 11. UOC strongly advises against the use of another manufacturer's tapered head, PMMA spacer or acetabular component with any UOC femoral stem component. Any such use will negate the responsibility of UOC for the performance of the resulting mixed component implant. 12. Return all packages with flaws in the sterile barrier to the supplier. Do not resterilize. 13. The shelf-life of UHMWPE made components is five years. PRECAUTIONS 1. Before clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and limitations of the device. Patients should be instructed in the limitations of the prosthesis, including, but not limited to, the impact of excessive loading through patient weight or activity, and be taught to govern their activities accordingly. If the patient is involved in an occupation or activity, which includes substantial walking, running, lifting, or muscle strain, the resultant forces can cause failure of the fixation, the device, or both. The prosthesis will not restore function to the level expected with normal healthy bone, and the patient should not have unrealistic functional expectations. 2. Appropriate selection, placement and fixation of the femoral stem and/or acetabular components are critical factors which affect implant service life. As in the case of all prosthetic implants, the durability of these components is affected by numerous biologic, biomechanic and other extrinsic factors, which limit their service life. Accordingly, strict adherence to the indications, contraindications, precautions and warnings for this product is essential to potentially maximize service life. 3. Care must be taken to protect the components from being marred, nicked or notched as a result of contact with metal or abrasive objects. UTILIZATION AND IMPLANTATION 1. The recommended trial components should be used for size determination, canal preparation evaluation, trial reduction and range of motion evaluation, thus preserving the integrity of the actual implants and their sterile packaging. 2. Radiographic templates are available to assist in the preoperative prediction of component size and style. 3. The UOC Surgical Protocols provide additional procedural information. PACKAGING AND LABELING All implants should be accepted only if received by the hospital or surgeon with the factory packaging and labeling intact. STERILIZATION 1. All components have been sterilized by gamma radiation, except highly crossed-linked polyethylene which sterilized by ethylene oxide (Eto). 2. The packaging of all sterile products should be inspected for flaws in the sterile barrier before opening. In the presence of such a flaw, the product must be assumed nonsterile. Special trial prostheses are available to avoid having to open any aspect of the sterile package prior to component use. 3. Care should be taken to prevent contamination of the component. In the event of contamination, this product must be discarded. 4. If the package is opened, but the product is not used, the component must not be resterilized and must be discarded or returned to the supplier. IMPORTANT FOR OPENED COMPONENTS The plastic components, if opened, are not permitted be re-sterilization by any method. The metal components, if opened, please return to United Orthopedic Corporation. A suitable handing in cleaning (if necessary), packaging and gamma radiation will be done. 34

38 Safety Statements - Full PE Cement Restrictor DESCRIPTION The UNITED restrictors are made of UHMWPE (ISO 5834). The shuttlecock-like shape makes them ideal for medullary cavity obturation. PACKAGING The restrictors are packaged in a STERILE double blister tray. They are packaged in such way to insure ready-to-use positioning of the product. INDICATIONS The cement restrictors are intended for obturation of the medullary cavity prior to the introduction of acrylic cement. They have been designed to inhibit the infiltration of cement into the diaphysis and to help generate pressure. They are physiologically inert and stable with respect to the heat generated during cement polymerization STERILIZATION The restrictors are delivered sterile, having been exposed to at least 25kGy of gamma radiation. The expiration date of the sterility is 5 years. CONTRAINDICATIONS These restrictors should not be used in patients who are hypersensitive to any of the product s constituents or with a history of allergy. 1. This device must only be used in a sterile operating room. Rigorous aseptic techniques must be practiced to prevent any risk of surface contamination. 2. This device is meant for single-use and must not be re-sterilized. 3. The product should not be modified in any way (it should never be cut or shaped). 4. Do not use if the packaging is damaged. 5. Do not use after the expiration date printed on the label. 6. Do not alow product come into contact with any pollutant, even if it is still in its packaging. SIDE EFFECTS No side effects have been reported. DIRECTIONS - Preliminary Checking Procedures - 1. Check for the expiration date and confirm that the packaging has neither been opened nor damaged in any way. 2. Use sterile gloves throughout the handling and installation of the device. 3. Check that the red dot-shaped sticker is visible on the external packaging (confirms that the product has been properly sterilized). INSTALLATION 1. Choose the reamer corresponding to the programming and introduce it into the medullary canal to check that the proper size is being used and adjust it to the required height. Use the restrictor of the same size as the reamer. 2. Take the restrictor out of its packaging. 3. Insert the holder into the restrictor and then fix it on the plug holder. 4. Introduce the whole assembly into the medullary cavity and position it approximately one centimeter below the prosthesis which is to be cemented in place. 5. Remove the plug holder. 6. Introduce acrylic cement.. 7. If any other technique is used, the consequences are entirely the operator s liability 8. A distance of one centimeter should be left between the end of the prosthesis and the restrictor. WARNING 1. In compliance with the regulations, this product should only be handled and implanted by fully qualified and trained healthcare professionals who are thoroughly familiar with these instructions. 2. The manufacturer must be notified immediately of any product which does not conform to the specifications. Observed deviation(s) should be recorded and reported in detail and, if possible, the product itself should be returned. 3. It is the prescribing surgeon s sole responsibility to provide patient any relevant information (on the efficacy of the device and any risks associated with the implanting operation) both before and after the procedure as well as confirming the compatibility of materials produced by other parties which are used in conjunction with this device. 35

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40 Each Step We Care Contact Us Taiwan United Orthopedic Corporation 12F, No.80, Sec.1, Chenggong Rd., Yonghe Dist., New Taipei City 23452, Taiwan Tel: Fax: China United Medical Instrument Co., Ltd. Room 402, Building 7, No.697, Ling Shi Road, ShangHai , China Tel: Fax: Japan United Biomech Japan Inc. Ginyo Bldg 4th floor, Kitasaiwai, Nishi-Ku Yokohama City, Kanagawa, , Japan Tel: Fax: USA UOC USA Inc. 20, Fairbanks, Suite 173, Irvine 92618, CA Tel: Fax: EU Representative mdi Europa GmbH Langenhagener Strasse 71, Langenhagen 30855, Germany Tel: Fax: Europe UOC (Suisse) SA Avenue Général Guisan 60A, Pully 1009, Switzerland Tel: Fax: UOC (France) 21, Rue de la Ravinelle, Nancy 54000, France Tel: Fax: Copyright 2017 United Orthopedic Corp. All rights reserved. UOC-UM-UN Rev.0 SEP. 2017