LIMA CORPORATE ANDDJO GLOBAL EXPAND U.S. PARTNERSHIP

S an Diego, CA, February 15, 2011 - Lima Corporate, a European-based orthopedic implants company and DJO

Global, Inc. (“DJO”, “DJO Global” or the “Company”), a global provider of medical device solutions for musculoskeletal health, vascular health and pain management, announced today that Lima Corporate has reached an agreement with DJO Surgical, a DJO Global business unit, for an expanded partnership for the United States implant market.The two companies initiated their collaboration in 2009 with a limited distribution agreement that leveraged each company’s product portfolios and increased their separate product offerings to better serve their respective customers. DJO Surgical launched the first of Lima’s products in the U.S., a revision hip system, late in the third quarter of 2010, with strong early sales momentum. Lima is successfully distributing DJO Surgical’s and Foundation Total Knee system in selected European markets. The new strategic partnership provides for an expanded range of DJO and Lima Corporate products to be jointly marketed in the U.S., offering customers quicker access to a comprehensive product portfolio in joint replacement, extremities and fracture repair. To support the new distribution partnership, a new legal entity, DJO Lima Orthopedics, LLC will be formed. The new agreement is expected to become effective by April 2011.In commenting on the new agreement, Stefano Alfonsi, chief executive officer for Lima Corporate said, “Lima Corporate has grown at a compounded annual growth rate of over 28% for the last two years in European and Asia-Pacific markets, reaching a leading position in shoulder and hip segments, driven by innovative orthopedic solutions and an aggressive geographic expansion. We are committed to continue our growth by offering Lima’s solutions to the sophisticated and demanding U.S. surgeons, and we are eager to embrace U.S. surgeons’ ideas and convert those ideas into exciting products. The partnership with DJO will enable us to efficiently access this market, and together with the well regarded DJO organization, to provide a high level of service to customers”.“We are very pleased to expand our relationship with Lima Corporate,” said Les Cross, president and chief executive officer of DJO Global. “Like DJO, Lima is an innovative company and the combination of our product portfolios will provide a state-of-the-art and comprehensive offering to better serve our customers and meet the needs of today’s complex procedures.” In a separate release today, DJO announced that its name has been changed from DJO Incorporated to DJO Global, Inc.

About DJO GlobalDJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices that provide solutions for musculoskeletal health, vascular health and pain management. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, and are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular systems, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO’s products are marketed under the brands Aircast®, DonJoy®, ProCare®, CMF™, Empi®, Saunders®, Chattanooga, DJO Surgical, Compex®, Cefar®-Compex® and Ormed®. DJO uses its website as a channel of distribution of material Company information. Financial and other material information regarding the Company is routinely posted and accessible at www.DJOglobal.com.

Stefano Alfonsi

C.E.O. Lima Corporate

NewsBulletin n. 18 - 2011The Magazine of Lima Corporate 1

Focus on

L ima Corporate is a great team always involved in an increasing internationalization process; to date, the Group is

directly present in 14 countries in the 3 continents and Lima is a worldwide well-known word thanks to its sales network.

From 2008, Hit Medica is part of Lima Corporate that works in research, design and production field, sinergically together with Lima.

This is the reason why Hit Medica has been pulled into the renewal and the regeneration of its institutional image and the new brand Lima Corporate|TRAUMA is the first visual and real expression of it:

Lima Corporate|TRAUMA springs from the desire to communicate, at visual level too, Hit Medica belonging to Lima head office.

The new brand looks into the Group from a privileged point of view; it mixes tradition and valours, implied in Lima brand, together with Hit Medica innovation and energy, summed up in the word “TRAUMA”: it is a great recall to the field of membership, traumatology as said, where the Group focuses its philosophy of innovation and state-of-the-art technology.

Starting from March, the new brand will be on the main communication supports you are going to receive.We ask you to be with us in this change, confirming once again Group dedication in facing future challenges.

Press Release

Diletta Iaia

Managing Director Lima Corporate|TRAUMA

Hit Medica renews image and style of its communication strategy

Lima Corporate announces:

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to

Products2

3DKnee prosthesis

T he number of knee prostheses implanted every year is increasing regularly, evidence of the growing confidence in

this type of implant and the increasing number of implants in young patients. This is why the choice of a prosthesis is no longer simply made on the basis of analgesic treatment, but also on the best possible functional solution. Patients are no longer satisfied to be simply pain free, but want to walk, go down stairs easily, enjoy leisure activities (gardening, cycling, swimming, etc.) or more, under the best conditions. Complete or almost complete flexion is required. This is why the old non-anatomical cam implants have shown their limits and surgeons now opt for implants which optimise mobility, joint kinematics and patella movement.

Within this context, the 3DKnee prosthesis distributed by Lima Corporate provides function based on tibiofemoral stability around a lateral pivot while preserving the tried and tested

principles of a sliding

prosthesis. Based on the principle that the anterior cruciate ligament must be sacrificed for any knee prosthesis, it has been designed to limit the anterior instability engendered. Its

asymmetrical condyle design provides extensive sliding owing to the wider, longer internal condyle, which is closer to the natural roll-back movement. A posterolateral lip, combined with a shorter external condyle limits external sliding and reinforces stability: this is the lateral pivot principle. This choice requires anatomical asymmetrical tibial plates. The lateral congruence increased by the posterior lip is intended to reduce occasional biomechanical stress, while providing a point of stability in flexion movements. Does this generate a greater risk of wear? work published with 4 years follow-up and studies on simulators (5 million cycles) are reassuring on this subject. Using tried and tested high molecular weight polyethylene combined with wider tibiofemoral contact zones and extended preservation of “natural” mobility are factors which limit wear. Finally, the patello-femoral design improves patella movement at the cost of deeper hollowing of the femur in the subtrochlear region, enabling high quality patellar resurfacing; patella stability is guaranteed.

Because of its anatomical design, this prosthesis requires accurate positioning and optimal ligament balancing; the broad release of the internal tibial plate allows the sliding movement to take place and ensures

symmetrical balance in flexion-extension, without

locking the lateral compartment. This ligament balancing takes place in flexion first then in extension; theoretically there is not much bone cutting to be done and it is the gradual release of ligament tension which leads to good balancing of the implant.

Clinically, the lack of a cam generates a moderate posterior drawer during flexion but this has no effect on walking or going downstairs. Mobility is at least equal to that of a “classic” total knee prosthesis, but is still dependent on preoperative amplitudes. Patella stability is good and is governed by the absence of pain in the patello-femoral system. In conclusion, the 3DKnee prosthesis distributed by Lima Corporate is an interesting development in sliding prostheses because it targets a physiological movement, without preserving the cruciate ligaments but with accurate peripheral balancing. The results published by the designers of this implant and the first clinical results, support this concept.

André Ferreira

Clinique du Parc Lyon - France

Clinical experience with the primary DELTA System in total hip replacement

T otal hip replacement is a widely-used procedure for treating coxofemoral pathologies, especially degenerative

hip diseases; generally with good results, due to the constant development of surgical techniques and implant technology.

We carried out a retrospective and descriptive study of the DELTA cup (Lima Corporate) as used in primary hip replacements to evaluate clinical results and possible complications associated with the technique. We reviewed 181 acetabula implanted between February 2005 and August 2009; with follow-ups ranging from ten months to four years, paying special attention to major perioperative and postoperative complications, such as dislocation or infection, as well as minor ones, such as discrepancies. An X ray review of the implants was also carried out to evaluate integration, osteolysis, position and calcification of the joints.

Results included perioperative complications in 0,5% cases (1 cracked acetabulum for technical mistake); infection in 1.6% cases; dislocation in 1,1% (in ceramic–ceramic couplings, only one required further surgery); discrepancies of 0,5cm to 1.5cm in 2,2% cases.

Total bone integration was present in all cases with no displacement of the acetabulum.

The mean size of the implanted cups was 54mm with a mean inclination of 47.5º. The series was made up of 126 ceramic liners and 55 protruded polyethylene liners.

We consider that with the hydroxyapatite-coated DELTA implants, we get very good bone integration as long as the proper surgical technique is used and the implant position is correct. None of the acetabula in our series showed displacement during follow-up.

José Luis Parra

Hospital Universitario Dr. Peset Valencia - Spain

POST-OPPRE-OP

POST-OPPRE-OP

Products 3

PRE-OP POST-OP

R evising a well fixed uncemented acetabular component is challenging. The host bone is often compromised, and the problem is made worse when there has been an adverse

reaction to metal debris. This can be associated with extensive osteolysis and soft tissue damage. We are seeing increasing numbers of these difficult cases caused by failure of metal on metal hip resurfacing and replacement.

The goals of surgery are to reconstruct bone defects, gain immediate primary stability and to encourage early bone in-growth. We have used the Lima Trabecular TitaniumTM system to revise failed metal on metal hip arthroplasty, and in complex primary hip replacement. The surface roughness of the shell gives excellent primary stability, with additional screw fixation as necessary, and the augments are useful when reconstructing larger defects.

The system allows the choice of several bearing options, an important factor when revising younger, more active patients. The short term results have been very encouraging, with excellent clinical and radiological outcomes.

Trabecular TitaniumTM for Complex Acetabular Reconstruction

Delayed hypersensitivity to metal in patients with total knee replacement

T otal knee arthroplasty may fail due to multifactorial causes which, however, all relate to either biological or mechanical

conditions. Biological causes include allergic reactions to metal, as documented in both individual patient and cohort studies. Around 10-15% of the general population is allergic or hypersensitive to metal. However, the phenomenon is not always predictable in case of joint replacements and the link between cause and effect in implant loosening cannot always be demonstrated with any degree of certainty.All metals in contact with biological systems corrode and consequently release ions. In predisposed individuals, these ions may activate the immune system by forming metal-protein complexes which, in turn, may trigger a series of reactions at the cellular level that eventually generate delayed hypersensitivity. Nickel, cobalt and chromium are the most

common allergens found in metal knee replacement devices. Titanium and vanadium as well as certain constituents of bone cement have been reported to elicit hypersensitivity responses.Numerous clinical trials have looked into possible correlations between allergy and implant failure, however, none have so far proven a definite link between the two events. One of the main challenges lies in the lack of universally accepted methods of investigation. Certain in vitro tests, based on the reactivity of the cells of the immune system to metal-proteins, have been proposed as diagnostic methods for evidencing metal allergy. These are expensive procedures that can only be performed by highly qualified centres that can analyse only certain materials. As an alternative, epidermal testing (patch tests) are cheaper and can be used to assess a larger number of elements simultaneously. Patch tests are the most commonly used method for diagnosing metal allergy.Recently, a trial was conducted by the Rizzoli Orthopedic Institute in Bologna (Italy), to assess the frequency of skin sensitivity in patients with knee implants, and to measure any impact this might have on the survival of the implant; the patch tests used the elements present in cobalt‐chromium‐molybdenum (CoCrMo) and titanium-aluminium-vanadium (TiAlV) alloys, and in bone cement. The study, coordinated by Dr. Donatella Granchi and Dr. Elisabetta Cenni, included three patient populations: one group of candidates awaiting a total knee replacement, studied prior to the procedure, another group of patients with stable knee implants and a third group of patients with clear evidence of loosening of the prosthesis.The frequency of metal sensitivity in the patients awaiting surgery was similar to that of the general population and the most common sensitizers were nickel, followed by cobalt,

chromium and manganese. The tests were significantly more positive in the patients with knee implants, both stable

and mobilized. More specifically, there was a higher frequency of positive reactions to vanadium in the stable implants with at least one component (the tibial plateau) in titanium-aluminium-vanadium alloy. A higher percentage of positive reactions to manganese was found in patients with loosening of the prosthesis in cobalt‐chromium‐molybdenum (CrCoMo). It

should be noted that the percentage of manganese in this alloy is very low, around just 1%.It was also interesting to observe that the same group of patients with loosening of the CrCoMo implant was found to have a more frequent positive patch test to vanadium than the general population. This finding could be due to cross-reactivity to vanadium and other elements such as manganese.These results could confirm the assumption that it is the individual’s genetic predisposition that is responsible for sensitisation responses, rather than a concentration of the sensitising agent. In this study, patch testing was unable to discriminate between stable and loose implants. However, implant loosening was observed to be 4 times more frequent in patients who reported symptoms associated with allergic reaction to metal before the knee replacement surgery.In conclusion, patients with a positive history of metal allergy should be assessed for possible sensitivity to the elements present in the metal alloys of knee implants. Patch testing is a valid rapid screening exam for all the elements contained in current total knee replacement. Nonetheless, this does not rule out the possible need for more extensive in vitro diagnostic testing in doubtful cases or to confirm reactivity to a small number of elements.With respect to metal-allergic patients, an excellent solution might be found in the use of aceramic femoral component combined with an “all-poly” polythene tibial component. This is the only type of coupling that will rule out the risk of implant elements triggering metal allergies. The use of new ceramic materials such as Biolox® delta (CeramTec AG, Stuttgart) appears to solve the structural limits posed by the fragile nature of ceramics, which currently requires fixation with bone cement.

Domenico Tigani

Policlinico Le Scotte Azienda Universitaria Ospedaliera Senese Siena - Italy

Jeremy Latham

Nuffield Hospital Hampshire in Southampton Southampton - United Kingdom

A few months ago, our San Marino facility installed a machine that has taken us to the cutting edge

of the biopolymer injection moulding industry.

Our highly complex, international GMP and FDA compliant moulding process is one of a kind in Italy and ranks among the top ten in Europe.

It is a well known fact that polymers in general, and bioresorbable plastics in particular, are a fast-growing resource in the production of both implantable medical devices and healthcare instruments.

The injection moulding process is ideal for manufacturing devices featuring a wide range of mechanical characteristics and resorption properties, and for enhancing high-end engineering polymers such as PEEK. Through close cooperation with polymer makers we are now able to test new additives to polymer matrices, including different types of carbon fibres, to further diversify the properties of injection moulded devices.

The injection moulding line, consisting of a press and the appropriate accessories, is situated in a clean room to eliminate the risk of contamination.

The process begins with resin pellets which are first pre-dried then fed into a plasticator, where they are gradually melted; the melt is then forced towards the mould.

When the desired Melt Flow Rate is achieved, the material is injected into the cavity of the mould, whose shape is that of the finished piece .Once the cavity is filled, the polymer is clamped under a holding pressure for the required cycle time, then cooled until the device solidifies.

We plan to launch a new product range in which we will leverage the outstanding characteristics of polymers to meet all osteosynthesis and joint reconstruction needs, thus offering surgeons more choices and better control of the procedure.

Events

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T. +39 0432 945511F. +39 0432 945512

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Limacorporate spa

Upcoming EventsMarch 4-5 Corso Formativo Teorico-Pratico “I problemi Posturali e le soluzioni Terapeutiche: dall’ortesi alla chirugia computer assistita” Milano - Italy

March 16-20 VIII Edizione ORTHONEWS Crans Montana - Switzerland

March 18 XVI Congresso Nazionale degli Specializzandi in Ortopedia e Traumatologia “Esperienze in ortopedia e traumatologia” Parma - Italy

March 21-25 The 31° Journées d’Orthopédie de Fort de France Fort de France - Martinique

March 21-25 31th Caribbean Orthopaedic Meeting Anse Marcel, Saint Martin - French Caribbean Island

March 22-24 26° Corso Teorico Pratico di Chirurgia Artroscopica Bologna - Italy

March 31- April 2 Congresso della Società Italiana di Artroscopia (SIA) e della Società Italiana Ginocchio-Artroscopia-Sport-Cartilagine-Tecnologie ortopediche (SIGASCOT) 1° Congresso di Chirurgia Articolare dei Paesi del Mediterraneo: Realtà e Prospettive Palermo - Italia

April 6-8 XXX Congreso de la Sociedad Española de la Rodilla (SEROD) San Sebastián - Spain

April 6-9 European Paediatric Orthopaedic Society (EPOS) 30th Annual Meeting Basel - Switzerland

April 20-22 IMUKA 2011 Masterclass in Arthroscopy and Related Surgery Maastricht - Netherlands

April 27-30 12th European Congress of Trauma & Emergency Surgery (ESTES) Milano - Italy

Announcing a technological breakthrough: injection moulding

Briefly

Shoulder Cadaver Lab- Madrid - January 2011

Stefano Caddeo

R&D Lima Corporate | TRAUMA

Roberto Cianci

Marketing&Business Development Lima Corporate | TRAUMA

Celjski Dnevi; Zlom Kolka V Sloveniji 2000 - 2010Slovenia - March 2011SMR User Meeting - Australia - February 2011

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Japan Society for Replacement

Arthroplasty (JSRA) Annual Meeting - Tokyo-

February 2011