Corin Group PLC

BONIT Coated Implants
Cautions
Contra Indications
Dual and Bi-coated Implants
General Statement
Handling
Hydroxyapatite Coated Implants
Implants
Medical Devices User Information – General Medical Statement
Mixing of Components
Modular Heads
Polyethylene Components
Porous Coated Implants
Post-operative Care and Follow-up
Pre-operative Planning
Privacy Policy
Re-sterilisation
Sterility
Titanium Nitride (TiN) Coated Implants

General Statement

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The Corin Group makes no representation as to the availability, accuracy, or completeness of the content of this site. The Corin Group shall not be liable for any damages or injury resulting from users’ access to, or inability to access this site or from reliance on any information at this site. Whereas the Corin Group makes every effort to protect this site from malicious third party access, The Corin Group will not be held responsible for any virus, Trojan, or third party user damage sustained as a direct result of accessing this site.

The site contains information about products that may or may not be available in any particular country or region of the world and where applicable, may be approved or cleared by a government regulatory body for sale or use with different indications and restrictions in different countries.

Persons accessing this website should not construe anything on the site as a promotion or solicitation for any product or for the use of any product that is not authorised by the laws and regulations of the country in which they might be located.

No information contained in this website constitutes or shall be deemed to constitute an invitation or inducement to invest or otherwise deal in the shares of Corin or an invitation or inducement by or on behalf of Corin.

This site may contain from time to time information related to various health, medical and fitness conditions and their treatment. Such information is not meant to be a substitute for the advice tendered by a doctor or other medical professional. Persons accessing this website should not use the information contained herein for diagnosing a health or fitness problem or disease. Persons accessing this website should always consult a professionally qualified medical adviser, to determine what courses of treatment, if any, may be appropriate for them.

The Corin Group may collect data from users, which may be provided to us voluntarily through this web site, such as names, postal addresses, e-mail addresses, telephone numbers, and other personal information. The information we collect is used to improve the content of our website and our standards of service to our Customers. Such information may be used to contact persons using this site, via e-mail or by regular mail, to provide them with information that The Corin Group believes may be of interest to them. The Corin Group will not sell or transfer the personal information transmitted to us by others outside the Company. All information that is not personal to any person accessing this website or to someone else, such as questions, comments, ideas and suggestions, shall be deemed to be non-confidential, and The Corin Group shall be free to disclose and use the same, without any obligation whatsoever towards the source of such information, for any purpose and through any means. If at any time persons accessing this website do not wish us to contact them, or if they have any questions concerning our privacy policy, please feel free to inform the Webmaster of this fact by sending an email to webmaster@coringroup.com. By choosing to send a message to The Corin Group, persons accessing this site acknowledge that all non-personal information contained in all messages, including feedback data, such as questions, comments, suggestions, or the like (collectively referred to as Feedback) will be considered to be non-confidential. The Corin Group shall have no obligations of any kind with respect to such Feedback, and shall be free to reproduce, use, disclose, exhibit, display, transform, commercialise, create derivative works and distribute the Feedback to others without limitation. Further, The Corin Group shall be free to use any ideas, inventions, concepts, know-how or techniques contained in such Feedback for any purpose whatsoever, including, but not limited to, developing, manufacturing and marketing products incorporating such Feedback. The Corin Group shall not be held responsible for technical problems that may occur during the process of electronic transfer over international networks that result in others viewing your information.

Under no circumstances should persons accessing this website use our web site or any of the fax and mailing addresses on the website to send The Corin Group confidential or proprietary information. The Corin Group does not want to receive such confidential or proprietary information. Data which is not personal, including questions, comments, ideas and suggestions shall be deemed to be non-confidential, and The Corin Group shall be free to disclose and use the same, without any obligations whatsoever towards the source of such information for any purpose and through any means.

Medical Devices User Information - General Statement

Please read carefully before utilising any product manufactured by The Corin Group.

The Surgeon must be fully conversant with the applicable operative technique and/or instructions for use where available. If additional information concerning the operative technique is required the information should be requested from the applicable Corin Group Sales Department or Distributor. The Surgeon or the surgical team must inspect the implants, surgical instruments and single use disposable devices prior to surgery to ensure they are undamaged and appropriate for use in the surgical procedure.

Implants

Corin Group orthopaedic implants are manufactured from the highest quality implant materials to very precise dimensions and tolerances.

They should only be implanted using the correct instruments and must not be scratched or hammered directly. It is important to follow aseptic procedures when removing the implant from its packaging. This is the responsibility of the user.
Implants should not be altered or adapted unless specifically designed to be adapted.

Damage to, or modification of, an implant may produce stresses or cause defects, which could result in, implant failure.

Under no circumstances must an implant be re-used. Each implant is designed for single use. Although an implant may appear undamaged, previous stresses to which it may have been subjected may cause failure if re-implanted.

Corrosion can occur when stainless steel implants are placed in the proximity of Cobalt Chrome or Titanium implants. The only such combination, which is permitted, is the application of a Corin Modular Head manufactured from Cobalt Chromium Molybdenum alloy (ISO 5832-4) to a Corin Femoral Stem manufactured from high nitrogen stainless steel (ISO 5832-9)

Patients must be warned by the operating Surgeon of the limitations and operative complications that can arise as a result of the surgical procedure.

Patients should be advised, by the operating Surgeon, of appropriate activity levels post-operatively.

The Surgeon must ensure that the appropriate surgical instruments are used in order to avoid potential damage to the implant.

Sterility

The Corin Groups implants are supplied sterile or non-sterile as specified on the product labelling.

The integrity of each component of the packaging should be checked carefully to ensure that product sterility has not been compromised.

Non-metallic and Hydroxyapatite coated implantable devices supplied non-sterile must be sterilised by gamma irradiation.

Sterilisation of devices supplied none-sterile, particularly with regard to the use of appropriate sterilisation cycle parameters, is the responsibility of the hospital.
If the devices are sterilised by the hospital the products must be removed from their protective packaging.

The devices must be sterilised in protective materials appropriate for the method of sterilisation concerned.

Re-sterilisation

Corin Medical implants must not be re-sterilised and/or re-used by the Customer.

Any implants which, for whatever reason, are required to be re-sterilised must be returned to Corin for assessment of the feasibility of re-sterilisation in accordance with the approved validated method.

Corifix and Corin Spinal System implants, unless they are to be included within a tray of implantable products, also must not be re-sterilised and/or reused.

Appropriate Corifix and Corin Spinal Systems implants which are supplied either sterile or non-sterile (as specified on the product labelling) may be included within a tray of implantable devices in order to permit the Surgeon to select the most appropriate devices to meet his/her clinical requirements during the course of the surgical procedure. These devices must be appropriately cleaned, utilising a validated cleaning process, prior to sterilisation by autoclave, utilising a validated sterilisation cycle, prior to use.

The manufacturer and distributor take no responsibility for sterilisation or re-sterilisation of implants undertaken by the hospital.

Under no circumstances must a zirconia ceramic modular head be sterilised by steam autoclaving.

Mixing of components

Corin recommends that Corin Group devices are not used in conjunction with other manufacturers’ implants unless specific standards allow mixing of products. The Surgeon should contact a Corin Group company representative for further advice if necessary.

Pre-operative Planning

Corin provides written operative techniques to ensure that the Surgeon and the surgical team are fully versed with the operative procedure.

Where appropriate, templates and trial components are provided for use with Corin Medical implants and should be used for verification of the definitive size of the component.

The Surgeon must always use a trial prosthesis for trial purposes. The trials should not be assembled with implants. The trials used should be appropriate for the implants. The devices should be used in accordance with the applicable operative technique.

If, during pre-operative planning, an appropriately sized component cannot be found; this type of prosthesis should not be used.

An appropriate size range of implants should be available prior to performing the surgical procedure.

Specific sizes of some implants are intended for use in a restricted population, e.g. weight limitations. The Surgeon should consult the applicable operative techniques for details of such restrictions.

Handling

The bearing surfaces of Corin Group implants are manufactured to exacting surface finish standards. Care must be taken during the surgical procedure to avoid any surface damage to the implant by surgical instrumentation or other devices. Only the appropriate impaction of placement instruments should be employed as outlined in the operative technique.

All implant surfaces must be completely cleaned prior to implantation in order to enhance fixation.

Hydroxyapatite Coated Implants

Hydroxyapatite coated implants have a layer of Hydroxyapatite ceramic applied by a special process.

Hydroxyapatite coated implants must not be immersed in water.

The implant should be handled with special care to avoid any damage to the coating. It must not be touched by any substance other than the packaging, clean gloves or patient’s tissue.

Cement should not be used with this type of implant.

It is essential that the implant is a good tight fit. Hydroxyapatite is not a substitute for cement in the event of poor implant fixation.

The use of the coating in total joint replacement has only short-term follow up. The functional long-term clinical effects of this device are, therefore, not known and cannot be guaranteed. Implant and coating design may vary according to current scientific data.

As with all implants, care should be taken in patient selection and criteria for usage.
Acidic local antibiotics may damage the Hydroxyapatite if added directly to the operative site in the vicinity of the coating.

Removal of a Hydroxyapatite coated implant may require the use of special instruments to disrupt the implant-bone interface.

BONIT Coated Implants

BONIT coated implants have a layer of calcium phosphate (CaP) coating applied by a special process.

BONIT coated implants must not be immersed in water. The implants should be handled with special care to avoid any damage to the coating. It must not be touched by any substance other than packaging, clean gloves or patient’s tissue.

Cement should not be used with this type of implant.

It is essential that the implant is a good tight fit. BONIT is not a substitute for cement in the event of poor implant fixation.

The use of the coating in total joint replacement has only short-term follow-up. The functional long-term clinical effects of this device are, therefore, not known and cannot be guaranteed. Implant coating design may vary according to current scientific data.

As with all new implants care should be taken in patient selection and criteria for usage.

Acidic local antibiotics may damage the BONIT coating if applied direct to the operative site in the vicinity of the coating.

Removal of a BONIT coated implant may require the use of special instruments to disrupt the implant-bone interface.

Porous Coated Implants

Porous coated implants have a layer of porous coating applied by a special process.
The implant should be handled with special care to avoid any damage to the coating. The coating should not be touched by any substance, other than the packaging, clean gloves or the patients’ tissue.

Cement can be used with porous coated implants.

It is essential that, if cement is not to be used, a good tight fit is obtained by the implant. Porous coatings are not a substitute for cement in the event of poor initial fixation.

As with all implants, care should be taken with patient selection and criteria for usage.

Dual and Bi-Coated Implants

Dual and bi-coated implants have a layer of Hydroxyapatite ceramic applied over a layer of porous coating; both coatings are applied by special processes.

Dual and bi-coated implants must not be immersed in water with or without ultrasound agitation.

The implant should be handled with special care to avoid any damage to the coating. It should not be touched by any substance other than the packaging, clean gloves or the patient’s tissue.

Cement should not be used with this type of implant.

It is essential that the implant is a good tight fit. Hydroxyapatite is not a substitute for cement in the event of poor implant fixation.

As with all implants, care should be taken in patient selection and criteria for usage.
Removal, of a dual coated implant may require the use of special instruments to disrupt the implant-bone interface.

Titanium Nitride (TiN) Coated Implants

Titanium nitride (TiN) is a thin ceramic coating that is applied to Titanium or Cobalt Chrome substrates by a physical vapour deposition process (PVD). It’s effect is to substantially increase the hardness and wettability, thus potentially reducing wear at the bearing surfaces.

The bearing surfaces are manufactured to exact surface finish standards and appropriate care must be taken during the surgical procedure to avoid any surface damage to the implant by surgical instrumentation or other devices. Only the appropriate impaction of placement instruments should be employed as outlined in the operative technique.

All implant surfaces must be completely clean prior to implantation, particularly where a cemented technique is used. This is to prevent bone cement adhering to the bearing surface, which may cause third body abrasion, potentially reducing the life of the prosthesis.

For nickel sensitive patients Corin only advocate using Titanium (Ti-6Al-4V) alloy implants coated with Titanium nitride.

Modular Heads

Corin Modular Femoral Hip Stems feature a trunnion which is specifically designed to fit modular heads manufactured by Corin Medical.

The trunnion and modular head are engineered to provide a precise taper fit between the two components. On no account should a Corin Modular Femoral Stem be used with a modular head not manufactured by Corin Medical. Similarly, a Corin Modular Head should not be used with a femoral stem not manufactured by Corin Medical.
Corin Modular Heads should be placed onto a clean trunnion. Placement should be by hand, with firm pressure and a slight twist. Under no circumstances must an impactor be used on ceramic modular heads.

In the event that a ceramic or metallic modular head is dropped, scratched or otherwise damaged, it must not be implanted.

Under no circumstances should other manufacturers’ ceramic heads be used with Corin Femoral Stems.

Corin has two tapered trunnions available for Modular Femoral Hip Stems. The standard Corin taper on femoral hip stems must only be used with the equivalent taper on Corin’s modular heads. Similarly, Corin femoral hip stems incorporating a 12/14 taper trunnion must only be used with Corin modular heads, which have the same 12/14 taper.

Polyethylene components

All of the ultra-high molecular weight polyethylene used by Corin in the fabrication of implant components is manufactured to specifications, which meet or exceed current ISO standards, in order to maximise the strength and wear resistance of the material. Many publications have emphasised that there is no suitable way to re-sterilise polyethylene while maintaining its physical properties. It is therefore imperative that no attempts should ever be made to re-sterilise polyethylene components by any method whatsoever.

Cautions

Prior to closure of the operative site the area concerned should be thoroughly cleansed in order to ensure that no bone particles, or bone cement etc are present, as such materials could cause post-operative complications, for example, with bearing surface wear, component dislocation, restricted motion etc.

Federal law restricts this device for sale by or on the order of a physician in the USA
Unless otherwise indicated on the product labelling, Corin Medical implantable devices are intended for use with bone cement in the USA.

When bone cement is used in the surgical procedure it is imperative that the manufacturer’s instructions are followed with regard to cement preparation and application in order to avoid potential post-operative aseptic loosening and other complications.

Post-operative Care and Follow up

The Surgeon must provide the patient with appropriate instructions, preferably in writing, regarding exercises and limitations on activities prior to discharge from hospital, in order to protect the implant from unreasonable stresses.

Patients receiving Corin Group implants should be advised, by the Surgeon, that the longevity of the implant may depend on their weight and level of activity.

High stress and contact activities should be avoided.

The patient should present for post-operative review by the Surgeon at defined intervals. The patient should be encouraged to report any post-operative complications to the Surgeon.