SL-PLUS Stem series with Ti-HA Instructions for Use

Instructions for Use

English

Patient sensitivity to implant materials Patient sensitivities or allergies to the materials of the implants, particularly to metal ions are possible. The type of materials for each implant is provided on the box label. The operating surgeon should include possible risk factors concerning sensitivities to implant materials as part of the preoperative planning. The SL-PLUS™ Standard and Lateral Femoral Stem with and without Ti/HA has not been evaluated for safety and compatibility in the MR environment. The SL-PLUS Standard and Lateral Femoral Stem with Ti/HA has not been tested for heating or migration in the MR environment.

• Validated according to DIN EN ISO 17665 (valid IQ/OQ (Commissioning) and product-specific qualification (PQ)) • Maximum sterilization temperature 138°C (280°F plus tolerance in accordance with DIN EN ISO 17665) • Sterilization time (exposure time at the sterilization temperature) at least 4 min at 132°C (270°F) / 134°C (273°F) When the instruments have been used in a surgery with a risk of contamination by TSE agents, the instruments should be properly disposed. User should only use the steam sterilizations cycles validated by the manufacturer as recommended in the Package Insert.

Reuse or modifications

Storage

Implants are intended for single use only and must only be used in their original condition. Modifications of any kind shall not be done, unless the surgical technique expressly describes it. Any re-use of single use labeled products can cause serious harm to the patient which can lead to serious injury or death.

Implants must always be stored sealed in their original packaging protected from direct sunlight. The implants shall not be used in any surgical procedure after the expiration date printed on each device label. Careful planning is recommended to assure that all products provided for a surgery are within their expiration date. Implants, implant parts and instruments that can no longer be used may be returned to the manufacturer for proper disposal.

Cleaning, disinfection and sterilization/ resterilization The recommendations given below are provided for information only. • In general, implants have been sterilized by a minimum of 25 KGy of gamma irradiation or by the use of ethylene oxide. Implants provided as sterile must not be resterilized by the purchaser. • Implants and instruments supplied as non-sterile must be cleaned, disinfected and sterilized before use, and can be resterilized as required. • Implants and instruments must not come into contact with agents containing the following components: aromatic or halogenated hydrocarbon, oxalic acid, oily substances, powerful acid and alkalis, peroxide/extreme oxidizing substances, organic solvents, ammoniac alkaline solutions and mercurial compounds. • For sterilization, instruments and non-sterile implants are to be placed in a suitable container. Note to US customers: Only FDA cleared sterilizers and wraps are to be used in the sterilization processes. Do not sterilize instruments in the protective bags in which they are supplied. Only the dynamic air removal steam sterilization methods listed below may be used for sterilization: • The weight of the fully loaded trays must not exceed 10kg (this must be observed if additional instruments are sterilized loosely in the tray) • Steam sterilizer according to DIN EN 13060/DIN EN 285 or ANSI AAMI ST79 (for USA:FDA clearance)

SL-PLUS™

General Surgical Steps Implantation must be carried out as defined in the surgical technique. This documentation is available from Smith & Nephew. To ensure the success of the operation, it is essential that the surgeon is familiar with the surgical technique recommended for this system and applies this technique with great care.

Preoperative planning Preoperative planning allows the surgeon to assess the choice of suitable components and possible combinations. Surgery should be planned in great detail based on analytical findings (i.e. X-ray, MRI). Additional implants should be available, in case other sizes are required or if the planned implant cannot be used. Failure to carry out a proper planning could lead into choosing the wrong implant type and/or size or incorrect implant positioning. For information about preoperative planning and the use of X-ray templates, please read the corresponding surgical technique and/or contact a Smith & Nephew representative.

Preoperative preparation Instruments Only Smith & Nephew instruments should be used to prepare the bone bed and to fit and insert the implant. Instruments may only be used in their original condition. The instruments are supplied as non-sterile and must be cleaned, disinfected and sterilized before use, applying the sterilization standards and operational procedures in force of the relevant institution. Please refer to the operating instructions

Instructions for Use

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Instructions for Use

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for the autoclave to determine the correct settings for the sterilization temperature and time.

information from the surgical technique. Postoperative treatment should be documented according to hospital internal guidelines.

Before use, the functionality of surgical instruments should be checked. The use of damaged instruments may lead to early failure of the implants.

The patient has to be instructed regarding allowed activity levels and possible motion. The patient should be encouraged to promptly report any unusual changes with regard to the operated site to their physician.

Implants When removing the implant from its packaging, check that the description on the package (REF number and size) is correct and ensure that surgical personnel follow the rules of asepsis. For traceability purposes, the LOT number of the inserted implant must be documented in the appropriate patient files. Additional labels are included in the product box to facilitate this purpose. Avoid implant contact with materials that might damage its surface. It is important to check the implant before it is inserted to ensure it is not damaged. Protective packaging shall only be removed immediately prior to use. 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.

Smith & Nephew total hip prosthesis is intended to replace a hip joint. This device is intended for primary or revision patients.

Device Description The SL-PLUS™ Stem and the SL-PLUS Stem Lateral are non-cemented press-fit stems made of wrought titanium alloy Ti-6Al-7Nb. The SL-PLUS/INTEGRATION-PLUS™ Stem with Ti/HA and the SL-PLUS/INTEGRATION-PLUS Stem Lateral with Ti/HA are manufactured based on the uncoated design of SL-PLUS Stem and the SL-PLUS Stem Lateral. Additionally, they have a titanium plasma sprayed coating with an additional thin layer of hydroxyapatite on the proximal part of the stem.

Indications The SL-PLUS Stem and the SL-PLUS/INTEGRATION-PLUS Stem with Ti/HA is indicated for: Indications Standard Stem

Intraoperative For implants intended for cemented fixation, the surgeon must follow the cement manufacturer instructions concerning the preparation, cementing technique and other information, and recommendations for use. Fixation is an essential factor for a firm and long-term implant seating. The following problems may cause the implant to loosen or can lead to complications: • Excessive weakness of the bone structure caused by preparation of the bone bed • Unsuitable choice of implant size • Inadequate cleaning of the bone bed before implantation • Application of excessive pressure when placing or fixing the implant can provoke fractures or bone damage Prior to closure, the surgical site has to be thoroughly cleaned from foreign particles, bone cement, bone chips or other debris.

Postoperative follow-up Every patient with a Smith & Nephew joint replacement requires consistent postoperative care by the surgeon or a suitably qualified expert. Postoperative care and treatment should incorporate recognized procedures and should take into account

SL-PLUS™

Product-specific Information

The SL-PLUS Stem and the SL-PLUS/INTEGRATION-PLUS Stem with Ti/HA is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head. Indications Lateral Stem The SL-PLUS Stem Lateral and the SL-PLUS/INTEGRATION-PLUS Stem Lateral with Ti/HA is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute). Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

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Contraindications

• Haematoma, wound haematoma and delayed wound healing

• Acute or chronic infections, local or systemic

• Bone fractures resulting from unilateral strain or weakened bone substance

• Severe muscle, nerve, or vascular diseases that endanger the respective limb

• Abnormal bending, loosening and repositioning of the implant

• Lack of bone substance or defective bone quality that endangers the stable seating of the prosthesis

• Abrasion of implant surfaces and development of osteolysis as a reaction to foreign bodies

• Any concomitant disease that may endanger the implant function

• Fracture of the implant, bone or cement

• Revision with extensive bone defects

Special information for use

Risk factors

Important Information on combination of Smith & Nephew products

These factors can influence the success of the operation:

• Generally weakened patient resistance (HIV, tumours, infections)

Implants and instruments manufactured or distributed by Smith & Nephew Orthopaedics AG and the former manufacturers Plus Orthopedics AG, Intraplant AG and PLUS Endoprothetik AG may be combined with each other. The surgeon must always ensure that the individual components are compatible and should take into account the following general restrictions on material combinations:

• Systemic diseases and metabolism disorders

Restrictions on head/insert combinations

• Osteoporosis • Osteomalacia • Severe deformations, congenital hip luxation

–– BIOLOX® forte / delta ceramic inserts must only be combined with BIOLOX® forte / delta ceramic ball heads

• History of infections • History of falls

Restrictions on head/taper combinations

• Drug, nicotine, alcohol or medication abuse

Material

• Overweight patient, obesity (body mass index >30) • Excessive shock and strain • Active sports and heavy labour • Thrombosis or pulmonary embolism during the operation caused by preparing the implant bed or inserting the implant • Postoperative morphological changes in the patient with weakening of the load bearing structures (e.g. tumours, hypertrophy, etc.) and/or changes in the materials used (e.g. attrition or fracture of the cement bed and/or tissue reactions to the implant) can lead to the following implant failures: –– Loosening, bending, crack formation or fracture of the components, the bone or the cement (if applicable) –– Wear and loosening of the implant can make it necessary to re-operate on the artificial joint

Possible side effects

• Dislocation, subluxation, insufficient range of movement, undesirable shortening or lengthening of the limb • Pain • Venous thrombosis and pulmonary embolism

–– Do not combine hip stems made of stainless steel (FeCrNiMoNbN) with femoral heads or modular neck sleeves made of cobalt-chromium alloys (CoCr,CoCrMo). Sizes Ball heads should only be combined with Smith & Nephew hip stems of identical taper dimensions and from Smith & Nephew Orthopaedics AG (or formerly Plus Orthopedics, Intraplant or PLUS Endoprothetik). Do not use Smith & Nephew Inc. 36mm -3 heads or any of the +16 heads with SL-PLUS Hip stems. Reliable fit of femoral ball heads on stem tapers

The complications listed below are among the most common adverse events resulting from hip arthroplasty:

• Infection

–– Do not combine femoral heads made of stainless steel (FeCrNiMoNbN) with any hip stem made of titanium (Ti6Al4V, Ti6Al7Nb) or cobalt-chromium (CoCr, CoCrMo) alloys.

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. To ensure that the ball head performs as required, it is essential to take great care when attaching it to the stem taper. The disposable plastic cap protecting the stem taper from damage shall not be removed until the trial ball is attached.

• Cardiovascular, pulmonary (e.g. fat embolism) and neuronal dysfunction SL-PLUS™

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Important information The ball head cannot simply be pressed in place by hand. Gently impact the ball head using a plastic impactor. For the revision of a femoral ball head, apply the following:

BIOLOX® forte / delta are registered trademarks of CeramTec GmbH, Germany. International Patent Protection: Hip Acetabular Component

• The corresponding insert also has to be removed.

US 6,537,321

EP 0 944 368

US 6,325,829

EP 0 998 245

• Never reuse a femoral ball head that has been impacted onto a stem cone and then removed.

US 5,443,520

EP 0 601 224

US 6,059,833

EP 0 732 903

• The use of ceramic ball heads is limited to new hip stems.

Hip Femoral Component

• In case of breakage of one component (femoral ball head or insert) used in a CE/CE tribological pairing, the other component has to be revised as well. All ceramic particles must be removed.

US 6,652,589

EP 0 985 387

US 6,540,788

EP 1 044 665

US 6,436,147

EP 1 062 923

US 6,808,539

EP 1 044 665

US 6,383,228

EP 0 943 297

US 6,344,060

EP 1 985 387

US 6,613,094

EP 1 044 664

US 6,540,788

EP 1 044 665

US 5,456,717

EP 0 601 223

US 5,593,446

EP 0 715 835

• Replacement only by a metal ball head or a ceramic revision femoral ball head coupled with a metallic taper adaptor.

• It is recommended that neither metal nor OXINIUM™ ball heads be used in the case of revision due to ceramic fracture as remaining fragments increase the risk of accelerated wear and reduced implant life of the replacement ball heads and polyethylene inserts. This may necessitate the removal and replacement of the femoral component to provide a suitable femoral taper to attach the new ceramic ball head. A ceramic on ceramic or ceramic on polyethylene articulating surface is recommended for any revision due to ceramic fracture. In the US, the revision option would be ceramic on polyethylene. If broken ceramic material is encountered, remove all loose identifiable fragments and thoroughly irrigate and lavage the operative site.

EP 0 137 040 EP 1 157 678

For U.S. package insert information visit: www.smith-nephew.com/ortholabeling or call 1 800 238 7538.

Important: Also refer to the surgical techniques and/or contact the appropriate Smith & Nephew sales representative for further information on the use of our products.

™ Trademarks of Smith & Nephew. Certain marks registered U.S. Patent & Trademark Office. ©2017 Smith & Nephew, Inc. All rights reserved.

SL-PLUS™

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