Endo-Model Standard / M Implants and Instruments Instructions for Use

Instructions for Use Implants 1. Brief description

• Packaging and implants to be discarded must be handled in compliance with national and local regulations for hospital disposal.

The implant systems, cemented or cementless by Waldemar Link GmbH & Co. KG are intended for the partial or complete replacement of a diseased joint or a diseased bone region. They consist of defined components that can be combined with each other in accordance with their approved uses. The selection and application of the devices presuppose standard training for orthopaedic and surgical specialists and suitable experience with orthopaedic and surgical procedures. The package inserts provided with the devices do not contain all of the information necessary for the selection and application of the devices. For proper handling, refer to other device–related instructions, such as the instructions on the surgical technique associated with the relevant system, as well as the special handling recommendations and device labels, where applicable. Refer to the identification tag on the implant and/or the packaging label for the definitive identification information on the device, such as system compatibility, article number, materials and shelf life. You should also take advantage of the training courses and printed materials provided for your information. To learn more, please contact the Waldemar Link GmbH & Co. KG sales office or your field representative.

2. Handling

The components are supplied sterile (gamma sterilization, at least 25 kGy) as single-use devices in individual packages. By contrast, components made of highly cross-linked polyethylene are sterilized with ethylene oxide (ETO) and are supplied as single-use products in individual packages. The packaging may contain protective components for the implants. These components are not intended for implantation. Implants should always be stored in their unopened protective packaging. Examine the packaging for damage before using the implant. Damaged packaging can have an adverse effect on both the sterility of the device as well as the proper performance of the implant, such that the device may no longer be used. Check the use by date on the implants. Implants with expired use by dates are no longer permitted to be used for implantation! Observe the pertinent standards for the aseptic handling of devices during and after removal of the implant from the packaging. When removing the packaging, make a record of the batch or serial numbers on the label, since this information is decisive for batch tracing. Self-adhesive labels with this information are enclosed with every package for your convenience. Caution! • Implants must be handled with great care and should not be modified or changed, even the smallest scratches and damages can considerably impair their stability or performance. Damaged implants are not permitted be used. • Manipulations, such as vigorous bending, kinking or bending backward are not permitted to be performed on implants that have fastening elements (e.g. straps) for intraoperative adjustment. • Surfaces provided for the connection of modular prosthetic components (cone, pins, screws) must not be damaged and may need to be cleaned with sterile liquid and dried before being joined together, so that neither blood nor any other coating impairs any of the connections, which could compromise the reliability of the connection. • In the case of broken ceramic components, the ceramic particles must be removed completely, since otherwise increased abrasion can be expected.

3. Storage

Sterile-packaged implants must be stored in the undamaged original packaging in buildings with adequate protection against damage due to impacts, frost, humidity, excessive heat, and direct sunlight. Further information is available from the manufacturer upon request.

4. Materials, implant selection, permissible combinations Titanium and titanium alloys, cobalt-chromium-molybdenum alloys and ultra high molecular weight polyethylene are used as basic materials. • Cobalt-based alloy (CoCrMo) according to ISO 5832-4/ASTM F-75 and ISO 5832-12/ASTM F-1537 • Titanium-aluminium alloy (TiAl6V4) according to ISO 5832-3/ASTM F-136 and ASTM F-1108 • Titanium (Ti) according to ISO 5832-2/ASTM F-67 • Ultra high molecular weight polyethylene (UHMWPE) according to ISO 5834-2/ASTM F-648 Further information on the material compositions is available from the manufacturer upon request. Please refer to the relevant surgical technique associated with the system and the identification on the packaging for further information on implant selection, permissible combination options and implant materials. Also refer to the relevant surgical technique for information on allocating and handling the instruments to be used for the implantation. Combinations with implants from other manufacturers and/or combinations with LINK implants that deviate from the surgical technique specifications have not been tested and are not permitted.

4.1 Permissible materials for tribological pairings: • CoCrMo alloy/UHMWPE

4.2 Cones:

The male and female cones of modular stem connections, such as a hip prosthesis stem with a hip prosthesis head, must match. Special attention must be paid to correct cone coupling. The cones have been optimally matched to each another and are not permitted to be combined with devices by other manufacturers.

4.3 Anchoring the implants:

Implant components are labelled as to whether they are to be cemented or not.

5. Indications and contraindications Refer to the surgical technique of the relevant prosthesis system for indications and contraindications.

6. Preoperative planning

Preoperative planning provides important information to identify the appropriate implant system and select the components of a system. Make sure that all components required for the operation are laid out and ready in the operating room. Test prostheses to verify proper fit (where applicable) and additional implants should be kept at the ready, in case other sizes are needed or the intended implant cannot be used. All LINK instruments necessary for the implantation must be on-hand and intact. If endoprosthetic joint replacement is indicated, then it must be taken into consideration, along with the overall picture of the patient: • that all non-surgical and surgical treatment alternatives for the joint disease have been considered

Page 2 of 5

• that artificial joint replacement performance is categorically inferior to natural joint performance, and an indication-related improvement in the preoperative condition is the only aim here • that an artificial joint may loosen due to stress, wear and tear, and infection, or luxation or dislocation may occur • that revision surgery, which under certain circumstances may exclude the possibility of restoring joint function, may be necessary due to loosening of the implant • that if the selection of cementless implants is indicated, the biological age of the patient, among other things, must be considered • that the patient consents to undergo the operation and accepts the risks involved • that if load-transferring bone cement and/or bone structures are damaged, then the loosening of the components, bone and implant fractures, as well as other serious complications cannot be ruled out • that if the patient is suspected of having allergies and tests positive on the applicable tests, then the patient’s foreign body sensitivities (material tolerances) must be examined Generally the mechanical failure or fracture of joint replacement prosthesis is a rare exception. However, this cannot be excluded with absolute certainty despite the sound structure of the implant. This may be due to stress on the implant and prosthesis as the result of a fall or accident, among other things. If the bone area where the implant is anchored is altered in such a way that the prosthesis is no longer able to withstand normal stress and an area of the prosthesis becomes subject to a stress imbalance, then a mechanical failure of the implant system may result. Such stress imbalances may also occur if the anchoring elements for the joint replacement implant are obliged to form a bridge over larger bone deficiencies without optimal reinforcement of the bone. It is recommended that the implant with the largest possible anchoring elements be used. Proper preparation for surgical procedures also includes the functional testing of implants and instruments prior to use.

8. Reprocessing

The implants are supplied as sterile single-use devices. Implants that have already been implanted are not permitted to be reprocessed. Instruments must be disinfected and sterilised prior to use. Please observe our separate sterilisation instructions for instruments. These are enclosed with every instrument upon delivery.

9. Resterilization

Our implants are designed for single-use only. Resterilization by the user is not permitted. Implants, as well as their materials are not suitable to be resterilized. Unpredictable degradations may occur in these implants during resterilization.

10. Circumstances that can interfere with the success of an operation

7. Possible risks and side effects

Surgery-related risks and side effects: • Blood loss, allogeneic/autologous blood transfusions • Swelling/haematomas • Thrombosis/embolism/heart attack • Impaired wound healing • Infections • Muscle and nerve damage • Damage to blood vessels • Postoperative pain • Complications associated with the anaesthesia applied • Postoperative calcification Implant-related risks and side effects: • Intraoperative fractures • Periprosthetic infection • Allergic reactions to implant components and abraded particles • Drop in blood pressure following application of bone cement • Implant fractures/ceramic material fractures • Implant loosening or subsidence • Implant malpositioning/misalignment • Reduced range of motion • Luxation of joint components • Discrepancies in the lengths of the extremities • Premature wear and tear - reoperation • Postoperative pain, e.g. thigh pain • Protrusion/Arrosion Page 3 of 5

• Severe osteoporosis • Severe deformities • Local bone tumours • Systemic diseases • Metabolic disorders • Case history of infections and falls • Drug dependency or abuse, including excessive alcohol and nicotine consumption • Obesity • Mental disorders or neuromuscular diseases • Heavy physical activities associated with strong vibrations • Hypersensitivities

11. Postoperative phase

In addition to movement and muscle training, special attention must be paid to carefully instructing the patient during the postoperative phase. Physician-supervised postoperative monitoring of healing progress is recommended. Where applicable, patients should also be advised on how to avoid overstraining themselves.

12. MRI Information

Waldemar Link GmbH & Co. KG implant systems have not been evaluated for safety and compatibility in the MR environment. The devices have not been tested for heating or migration in the MR environment. The risks associated with a passive implant in an MR environment have been evaluated and are known to include heating, migration, and image artifacts at or near the implant site.

13. Important •

•

• •

If the implantation of a LINK implant system is considered to be the best solution for the patient and one of the circumstances described in section 10 is applicable to the patient, it is necessary to advise the patient with regard to the anticipated effects that these circumstances could have on the success of the operation. It is further recommended that the patient be informed about measures that he or she can take to reduce the effects of such complications. All information provided to the patient should be documented in writing by the operating surgeon. The patients should be instructed in detail about the limitations of the implants, especially about the effects of excessive stress caused by body weight and physical activity, among other things. They should be encouraged to adjust their activities accordingly. Proper selection, placement and fixation of the devices are decisive factors, which will determine the life of the implant. Enquiries of any kind should be directed to Waldemar Link GmbH & Co. KG (see contact information on the cover sheet). The same applies for requests for further information on the devices.

Instructions for Use Instruments Instructions for Use on the Handling and Processing Link Endo-Model Rotating Hinge Knee Instrumentation (MIRETO) Our devices and instruments are designed and manufactured to meet the highest quality standards. We do not accept liability for products that have been modified, subjected to unintended use, or used improperly. Single-use products may not be reused. The package inserts provided with the devices do not contain all of the information necessary for the selection and application of the devices. For proper handling, refer to other device–related instructions, such as the instructions on the surgical technique associated with the relevant system, as well as the special handling recommendations, where applicable.

1. Initial use

The instruments are provided clean, but non-sterile. Non-sterile devices must be cleaned, disinfected and sterilized in accordance with Section 2 and 3 prior to initial use. All users in central sterile supply departments and operating rooms should familiarize themselves with the function and compatibility of an instrument before it is used.

1.1. Reprocessing

Deformed instruments shall not be used again. Hollow instruments shall be cleaned by rinsing/flushing with a syringe and or micro brush by use of sterile water. The instruments shall be stored in a dry condition. The reprocessing shall be done as soon as possible after the surgery.

2. Manual cleaning

• First rinse under cold water (room temperature) for at minimum five (5) minutes for a pre cleaning to avoid any protein fixation to the medical device • Second rinse under warm running water (38° to 49°C) for a minimum of two (2) minutes to remove visible soil and debris. • Completely immerse the devices in a neutral-pH enzymatic solution (e.g., Enzol) prepared according to manufacturer’s instructions and allow immersed devices for not less than five (5) minutes. • Clean the devices carefully using a brush with soft plastic bristles (taking special care with cavities and other poorly accessible areas) until all visible soiling (if any) has been removed. Lumens should be cleaned using a long, slender brush with soft bristles (e.g. a pipe cleaner). Note: The enzymatic solution should be changed if it has become visibly contaminated (e.g., with blood) or has become turbid. Do not use any metal brushes or steel wool for cleaning. • Take the devices out of the enzymatic solution and for at least three (3) minutes rinse in warm (38° to 49°C) tap water. Rinse out lumens, openings and other poorly accessible areas thoroughly. • Completely immerse the devices in an ultrasonic cleaning bath filled with neutral-pH enzymatic solution prepared according to manufacturer’s instruction and clean ultrasonically for no less than ten (10) minutes at 45-50 kHz without using the heater • Rinse the instrument thoroughly with warm (38° to 49°C) water in conformance with AAMI TIR34:2008 for at least three (3) minutes • Rinse the devices with water in conformance with AAMI TIR34:2008 for two (2) minutes and repeat rinse two additional times for not less than two (2) minutes for each rinse • Dry the instrument with a clean, absorbent and lint-free cloth • Repeat the cleaning procedure if the devices appear to be soiled after initial cleaning and until there is no visible sign of soil on the devices.

Page 4 of 5

Note: Reprocessor’s need to qualify to its own satisfaction any disposable materials, such as pipe cleaners, brushes, and lint-free cloth.

3. Sterilization

Our instruments are designed for sterilization in Pre-Vacuum using the following cycle parameters:

8. Servicing

Medical devices and instruments that are sent in for servicing must be processed beforehand in such a way that they cannot constitute a hazard to third parties. We will be pleased to provide you with further information about special instrument sets, their applications, disassembly, cleaning, and care.

Pre-Vacuum Cycle Cycle Temperature:

132°C / 270°F

Cycle Time:

4 min

Dry Time:

20 min

Care must be taken to ensure that before the instruments are sterilized they have been disassembled and opened. With regard to handling and loading please follow the instructions provided by the manufacturer of your sterilizer. Sterilization can be performed using FDA cleared sterilization wraps or in a dedicated tray in a sterilization container.

4. Performance test

Instruments must be tested for their fitness for operation and their functional efficiency every time before they are used. In addition, they must be devoid of visible residues and/or soiling. In particular, areas and functions such as measuring functions, compatibilities, shapes, cutting edges, tips, connections, closures, locks, detents, and moving components should be checked. Components and instruments made of plastics must be checked for wear due to ageing, e.g. cracks, embrittlement or chipping, and if such damage is evident they may no longer be used but must be replaced with new instruments. The service life of instruments depends on materials, design, use, and processing. Therefore do not use damaged instruments or ones with evident changes in surfaces. Do not perform repairs yourself. Servicing and repairs may only be performed by the manufacturer’s suitably qualified personnel.

5. Maintenance

After every use, subject the instruments to an inspection/performance test. After cleaning and thermal disinfection, hinge joints, screw threads and other moving parts must be coated with physiologically safe oil in order to reduce friction and wear.

6. Handling and storage

Surgical instruments must always be treated with care; this particularly applies during transport, cleaning, maintenance, sterilization, and storage. The sterile status of the instruments depends, inter alia, on the sterile items packaging and the prevailing storage conditions and must be established together with the operator’s hygiene officer on a caseby-case basis. Direct sunlight must be avoided. Improper handling and care, as well as unintended use, can lead to premature wear or damage.

7. Complaints about our products

Complaints of whatever kind must be filed with Waldemar Link at: [email protected]. When filing a complaint, always quote the name or REF number of the relevant component along with the LOT number, your name and your contact address. Describe the reason for the complaint in brief.

Page 5 of 5