Surgical Technique

Bipolar ProtheseBipolar Prosthesis

Bipolar Prosthesis

Note The following technique is for informational and educational purposes only. It is not intended to serve as medical advice. It is the responsibility of treating physicians to determine and utilize the appropriate products and techniques according to their own clinical judgment for each of their patients. For more information on the Bipolar Prosthesis, including its indications for use, contraindications, and product safety information, please refer to the product‘s label and the Instructions for Use packaged with the product.

Prior to performing this technique, please consult the Instructions for Use documentation provided with each device for additional health and safety information, including indications, contraindications, warnings and precautions.

Table Of Contents

Concept ............................................................................................................................... 4

Indications ........................................................................................................................... 4

Contraindications ................................................................................................................ 4

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

Sterilization .......................................................................................................................... 8 Implants ......................................................................................................................... 8 Instrumentation ............................................................................................................. 8

Implants ............................................................................................................................... 9

Instrumentation ..................................................................................................................10

Surgical Technique - Bipolar Prosthesis 3

The Bipolar Prosthesis consists of an outer shell of stainless CrNiMo steel according to ISO 5832-1, a polyethylene (UHMWPE) insert, according to ISO 5834-2, and locking ring. The Bipolar Prostheses are available in 22 sizes (39-60mm, in 1mm increments) and can be combined with a 22mm diameter femoral head (39-42) and a 28mm diameter femoral head (43-60).

The Bipolar Prosthesis is intended for use as a hemiarthroplasty, therefore the acetabulum is conserved since the main articulation occurs between the femoral head and the Bipolar Prosthesis.

Note:Metal, Ceramic and OXINIUM™ Femoral Heads can be used with the Bipolar Prosthesis in the following sizes:

• 22 S/+0, 22 M/+4, 22L/+8

• 28 XS/-3, 28 S/+0, 28M/+4, 28 L/+8, 28 XL/+12, 28 XXL/+16

• 22XL /+12 must not be used with BIPOLAR Prosthesis.

A detailed overview of the available femoral heads is on p. 11.

Concept

• Fracture or avascular necrosis of the femoral head.

• Acute or chronic infections, local or systemic

• Local infections in the area operated

• Severe muscle, nerve or vascular diseases that endanger the extremity in question

• Lacking bone substance or inadequate bone quality that endangers a stable seating of the prosthesis

• All concomitant diseases that may endanger the function of the implant, such as:

• Any allergies to implant materials

• Renal insufficiency

• Cardiac insufficiency (e.g., as a result of increased metal/ion concentrations in the blood)

• Pregnancy.

Indications

Contraindications

4 Surgical Technique - Bipolar Prosthesis

The following may not be implanted under any circumstances

• Implant components that have been damaged or scratched

• Implants that have been handled inappropriately or processed in a way that is not part of the surgical technique

• Implants that have already been used

• Implants where the packaging and/or labelling is damaged or not intact please return the affected devices to the appropriate Smith & Nephew representative or sales office.

• Material: Stainless steel (FeCrNiMoNbN) heads and stainless steel stems should only be used together. Neither should be used with other metal components.

• Sizes: all ball head sizes of Smith & Nephew Orthopaedics AG can safely be used with all hip stems of Smith & Nephew Orthopaedics AG. For combinations with components of other manufactures (e.g. Smith & Nephew Inc.), the surgeon must verify if the combination is allowed as listed in the compatibility matrix (lit. no. 04758) available on www.smith-nephew.com/education. Ball heads should only be combined with hip stems of identical taper dimensions.

Reliable fit of femoral ball heads on stem tapers

The taper connection can only be reliably and firmly seated if the surface of the ball head cone and the surface and structure of the hip stem taper are completely intact. The disposable plastic cap protecting the stem taper from damage shall not be removed until the trial ball is attached. To ensure that the ball head performs as required, it is essential to take great care when attaching it to the stem taper: Clean and dry the neck taper with a clean, sterile cloth. Place the prosthetic femoral head on the neck taper and firmly impact with the femoral head impactor and a mallet several times. Never reuse a femoral ball head that has been impacted onto a stem cone and then removed.

Femoral ball head revisions

For the revision of a femoral ball head, apply the following:

• The corresponding insert has to be revised as well.

• Replacement only by a metal ball head or a special ceramic revision femoral ball head featuring a metallic taper adaptor (BIOLOX®OPTION). Do not assemble a standard ceramic head on a used taper; the ceramic head may fracture from irregularities on the femoral component taper.

• In the case of a revision involving a fractured ceramic component, femoral ball head and insert have to be revised. Remove all loose identifiable fragments and thoroughly irrigate and lavage the operative site. A special ceramic revision femoral ball head coupled with a metallic taper adaptor should be used if the femoral taper is intact. Metal or Oxinium femoral ball heads with a polyethylene insert shall not be used for revising fractured ceramic components. In case the taper is damaged or no appropriate ceramic revision femoral ball head is available, the femoral stem must be revised to provide a suitable femoral taper to attach a new ceramic ball head.

Warnings and Precautions

Restrictions on head/taper combinations

Surgical Technique - Bipolar Prosthesis 5

Position the patient and expose the femoral head to produce a clear view of the fracture.

Divide the femoral neck using the oscillating saw.

Remove the head and the rest of the femoral neck.

Measure the resected femoral head.

Surgical Technique

6 Surgical Technique - Bipolar Prosthesis

Determine the definitive femoral head diameter with a Bipolar trial head size M/+4 and screw onto the trial head handle. If the measurement is between two sizes, select the smaller implant.

The Bipolar Prosthesis is supplied in preassembled form, and the locking ring has to be removed first using the special reduction forceps. If the Bipolar Prosthesis has to be separated from the femoral stem in a revision, the special reduction forceps are also used for removing the locking ring.

For the trial reduction, place the Bipolar trial head size M/+4 on to the stem, manipulate and select the final femoral head size. If the joint fit is too tight, use a size S/+0 femoral head. If excessive play results with neck length M/+4, use a size L/+8. In extreme cases of excessive tightness or play, respectively a femoral head with neck size XS/-3 and a femoral head with neck size XL/+12 or XXL/+16 may be used.

Place the locking ring over the stem neck (holes for reduction forceps on the distal side).

Before positioning the final femoral head with the correct size, carefully wash the stem cone with water and then dry. Position the femoral head and secure in place with slight rotation. Permanently fix the femoral head with a firm blow of a plastic hammer. If a metal hammer is used, a plastic coupling or the head impactor must be used to protect the femoral had from direct contact with the hammer.

Important notePressing the femoral head onto the trunnion solely by hand provides inadequate fixation.

Mount the Bipolar Prosthesis on the femoral head and secure with the locking ring. Ensure that the locking engages correctly.

Reduce and manipulate the prosthesis again to check the proper functioning and close the wound.

Surgical Technique - Bipolar Prosthesis 7

ImplantsAll implants described in this surgical technique are delivered in sterile condition by the manufacturer. Resterilization is not allowed.

InstrumentsSystem components are delivered in non-sterile condition. Prior to use, they should be cleaned according to internal hospital regulations and sterilized in an autoclave according to the legal regulations and guidelines valid in the particular country. Detailed information can be found in the info sheet (lit. no. 03389 [1363]).

The correct settings are given in the instructions for use issued by the autoclave manufacturer. Instrument manufacturers and distributors accept no responsibility for the sterilization of products by the customer.

Sterilization

8 Surgical Technique - Bipolar Prosthesis

MaterialStainless steel (CrNiMo) according to ISO 5832-1/UHMWPE according to ISO 5834-2

Implants

SAP no. Art. no. Size ø

7510-0912 75100912 39 22mm

7500-0913 75100913 40 22mm

7500-0914 75100914 41 22mm

7500-0915 75100915 42 22mm

7500-4360 16782 43 28mm

7500-4363 16783 44 28mm

7500-4364 16784 45 28mm

7500-4365 16785 46 28mm

7500-4366 16786 47 28mm

7500-4367 16787 48 28mm

7500-4368 16788 49 28mm

7500-4369 16789 50 28mm

7500-4370 16790 51 28mm

7500-4371 16791 52 28mm

7500-4375 16792 53 28mm

7500-4376 16793 54 28mm

7500-4377 16794 55 28mm

7500-4378 16795 56 28mm

7500-4379 16796 57 28mm

7500-4380 16797 58 28mm

7500-4381 16798 59 28mm

7500-4382 16799 60 28mm

Surgical Technique - Bipolar Prosthesis 9

Set No 75210375

Instrumentation

SAP no. Art. no. Description Length

7500-4122 160441 Trial head 39mm M/+4mm

7500-4121 160438 Trial head 40mm M/+4mm

7500-4123 160442 Trial head 41mm M/+4mm

7500-4110 160421 Trial head 42mm M/+4mm

7500-4124 160443 Trial head 43mm M/+4mm

7500-4111 160422 Trial head 44mm M/+4mm

7500-4125 160444 Trial head 45mm M/+4mm

7500-4112 160423 Trial head 46mm M/+4mm

7500-4126 1600445 Trial head 47mm M/+4mm

7500-4113 160424 Trial head 48mm M/+4mm

7500-4127 160446 Trial head 49mm M/+4mm

7500-4114 160425 Trial head 50mm M/+4mm

7500-4128 160447 Trial head 51mm M/+4mm

7500-4115 160426 Trial head 52mm M/+4mm

7500-4129 160448 Trial head 53mm M/+4mm

7500-4116 160427 Trial head 54mm M/+4mm

7500-4130 160449 Trial head 55mm M/+4mm

7500-4117 160428 Trial head 56mm M/+4mm

7500-4131 160450 Trial head 57mm M/+4mm

7500-4118 160429 Trial head 58mm M/+4mm

7500-4132 160451 Trial head 59mm M/+4mm

7500-4119 160430 Trial head 60mm M/+4mm

7500-4158 160901 Handle for trial heads

7500-4159 160902 Reduction forceps

7500-7656 990014 Easy tray

7500-7679 999997 Silicon mat

Trial head

Handle for trial heads

Reduction forceps

10 Surgical Technique - Bipolar Prosthesis

12/14 CoCr Femoral Heads

12/14 Stainless Steel Femoral Heads

12/14 BIOLOXTM Delta Ceramic Femoral Heads

12/14 BIOLOXTM OPTION Ceramic Femoral Heads

12/14 OXINIUM™ Femoral Heads SAP no. Size

71302200 22 S/+0

71302204 22 M/+4

71302208 22 L/+8

71302803 28 XS/-3

71302800 28 S/+0

71302804 28 M/+4

71302808 28 L/+8

71302812 28 XL/+12

71302816 28 XXL/+16

SAP no. Size

71292200 22 S/+0

71292204 22 M/+4

71292208 22 L/+8

71292803 28 XS/-3

71292800 28 S/+0

71292804 28 M/+4

71292808 28 L/+8

71292812 28 XL/+12

71292816 28 XXL/+16

SAP no. Size

75007451 28 S/+0

75007452 28 M/+4

75007453 28 L/+8

SAP no. Size

75103182 28 S/+0

75103183 28 M/+4

75103184 28 L/+8

75103185 28 XL/+12

SAP no. Size

71342200 22 S/+0

71342204 22 M/+4

71342208 22 L/+8

71342803 28 XS/-3

71342800 28 S/+0

71342804 28 M/+4

71342808 28 L/+8

71342812 28 XL/+12

71342816 28 XXL/+16

Surgical Technique - Bipolar Prosthesis 11

ManufacturerSmith & Nephew Orthopaedics AGOberneuhofstrasse 10d6340 BaarSwitzerland

Not for use in the U.S.

www.smith-nephew.com

™Trademark of Smith & Nephew.All Trademarks acknowledged.©2020 Smith & Nephew13170-en (1166) V2 01/20 Supporting healthcare professionals

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