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Zimmer Logo

 Press Release July, 2009

Alloclassic® Zweymüller® Hip Stem Marks 30 Years of Clinical History

With 30 years of impressive long-term success, the Alloclassic Zweymüller hip stem represents a milestone in the endoprosthetic treatment of the hip joint. Its durability, load resistance, secondary stability and straightforward surgical technique combine to meet the rigorous demands of top orthopaedic surgeons. Numerous published studies confirm the excellent clinical experience of the Alloclassic Zweymüller hip stem [1;2,3;4,5;6] and distinguish it from replications [6]. The Alloclassic Zweymüller stem continues to set the standard for uncemented total hip replacement solutions.

Despite visual similarities, there are many fundamental differences in hip prostheses. Zimmer’s Alloclassic Zweymüller hip stem is the only original product with this specific design and is distinguished by its high-performance material and sophisticated manufacturing. Its rectangular cross-section, tapered straight stem and distinctive trochanter region provide the basis for both secure primary fixation and rotational stability. The anterior and posterior distance between the stem and the diaphyseal cortex helps ensure endosteal blood supply and reduces the risk of avascular necrosis [2]. The biocompatible titanium alloy Protasul®-100 enables excellent osseointegration and, thus, excellent secondary stability for an established time-frame of at least ten years [1]. Together, these properties make the Alloclassic Zweymüller hip stem suitable for broad use in the majority of femur shapes and age groups.

Excellent long-term results

The Alloclassic Zweymüller stem was first introduced in 1979 and now has more than 30 years of clinical history in more than 520,000 patients [7]. Indeed, this uncemented hip prosthesis, with its streamlined surgical technique, is one of the most frequently implanted stem worldwide.

More than 100 published studies have provided in-depth examination of the stem’s long-term performance and have revealed low rates of revision. At 15 years postoperative, 98% of the Alloclassic Zweymüller stems were still functional [3], and survivorship at 18 years was 95% [4]. One study, which covered a period of 13 years, indicated a 0% revision rate [5]. Even minor design deviations can expose a replication to a measurable, significant increase in risk of future prosthetic loosening [6] — a fact which led the study’s authors to state their preference for the original Alloclassic Zweymüller implant.

Conclusion

The Alloclassic Zweymüller hip stem helps enable surgeons to achieve excellent long-term results. Decades of clinical use and solid research data corroborate the success of this original cementless implant. Orthopaedic clinicians and researchers attribute its remarkable performance to the high quality of its design, material and precision manufacturing.

References:
[1] Garcia-Cimbrelo E. et al. J Bone Surg Am 2003; 85-A: 296-303
[2] Delaunay C et al. J Arthroplasty 2001;16: 47-54
[3] Grübl A et al. J Bone Joint Surg Am 2006; 88: 2210-2215
[4] Reigstad O et al. Acta Orthopaedica 2008; 79: 194-202
[5] Pieringer H et al. J Arthoplasty 2006; 21: 967-974
[6] Lester DK, Wick M. J Bone Surgery (Br.) 2004; 86-B: 1108-1114
[7] Data on file at Zimmer


 Press Release May, 2009

  CLS® Spotorno and Alloclassic® Zweymüller® Hip Stem


Backed by Decades of Documented Success [1;2].

hip stem The 1980s saw a revolution in total hip replacement procedures, shifting from conventional cemented implants to uncemented endoprostheses. While a large number of uncemented designs were introduced during this time period, very few can claim 25 years or more of continuous use and such an amount of clinical data. The Alloclassic Zweymüller and CLS Spotorno hip systems, with their optimized design details, inspired many emulators. However, documented evidence demonstrates that even minor deviations from the original implants with respect to design or material properties can affect the longevity of the implants [1].

 The Alloclassic Zweymüller hip stem was first implanted 30 years ago and the CLS Spotorno hip stem, 25 years ago. Since then, these stems have become two of the most frequently used — and most successful — uncemented total hip replacement systems. Their continued clinical success is attributed to Zimmer’s expertise in tribology, development and sophistication in manufacturing joint replacement solutions. Over the years, through close collaboration with accomplished joint replacement surgeons, the CLS Spotorno and Alloclassic Zweymüller hip stems were optimized to provide enhanced stability, wear characteristics, and range of motion. In the last 25 years, a level of quality has been achieved that would be very difficult to exceed, as expressed in the markedly low revision rates of the prostheses [2;3].

Long-term resultsgraph of revisions

Independent data published in the world-renowned Swedish Hip Arthroplasty Registry demonstrated that the CLS Spotorno hip stem had a survival rate of 99% after 13 years [2]. Thus, only 1% of the clinically documented endoprostheses required revision before an in-situ time of 13 years. Similarly good survival rates of up to 100% at 13 years postoperative are documented for the Alloclassic Zweymüller hip stem [3]. Even in younger patients (mean age of 52 years), where the implant is subjected to increased physical activity, a survival rate of 95% at 18 years postoperative was reported [4]. It is clear that in more than 25 years, the CLS Spotorno and Alloclassic Zweymüller hip stems have set a standard for quality that is distinguished by low revision rates and long-term survivorship.

Unmatched quality

hip stem 2 

 The successes of the original CLS Spotorno and Alloclassic Zweymüller hip stems have led others to copy these two prostheses. Yet, the long-term results of uncemented hip implants depend on specific designs and material properties. Even minimal deviations from the original can lead to different clinical results [1]. A replica of a product design does not include all clinically relevant details, because the expertise in material and process technologies simply cannot be copied. The excellent documented clinical results apply only to the original CLS Spotorno and Alloclassic Zweymüller implants, and not to replications of their designs.



Conclusion

Thanks to their sophisticated designs, precise manufacturing and further optimization, the Alloclassic Zweymüller and CLS Spotorno hip stems have achieved clinical success for 30 years and 25 years, respectfully. Surgeons worldwide have reported high levels of satisfaction and outstanding survivorship rates with these uncemented systems. Because the clinically relevant details of material and design cannot be copied, the long-term results of these two original implants do not apply to replications.

About Zimmer Holdings, Inc.

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer designs, develops, manufactures and markets orthopaedic reconstructive, spinal and trauma devices, dental implants, and related surgical products. Zimmer has operations in more than 25 countries around the world and sells products in more than 100 countries. Zimmer’s 2008 sales were approximately $4.1 billion. The Company is supported by the efforts of approximately 8,500 employees worldwide.

Contact:

Xavier Langlois
Global Brand Management Hip
Zimmer GmbH
Sulzer-Allee 8 / P.O. Box
CH-8404 Winterthur
Phone +41 (0)52 262 72 74
Main +41 (0) 52 262 60 70
xavier.langlois@zimmer.com
www.zimmer.com

References

[1] Lester DK, Wick M. J Bone Surgery (Br) 2004; 86-B: 1108-1114
[2] www.jru.orthop.gu.se
[3] Pieringer H et al. J Arthoplasty 2006; 21: 967-974
[4] Reigstad O et al. Acta Orthopaedica 2008; 79: 194-202


Lima Corporate Logo

Press Release May 4, 2009

Lima Corporate and DJO Incorporated’s Surgical Division sign product distribution and OEM agreement contract

Villanova di San Daniele, Italy, May 4, 2009 - Lima Corporate, Italian based orthopaedics implants company, has signed an agreement with DJO Surgical, formerly Encore Medical, surgical division of DJO Incorporated, a global provider of products and services that promote pain management and musculoskeletal and vascular health. The strategic partnership will allow Lima Corporate to distribute select DJO Surgical products in several countries in Europe, while Lima Corporate will provide products for sale in the US through DJO Surgical.

As a starting point, Lima Corporate will distribute DJO Surgical’s Lima Corporate Logo and Foundation™ Total Knee Systems in selected European Markets. The result of more than a decade of research, the 3DKnee is the first knee implant specifically engineered to accommodate the important changes in contact, movement, and pressure that occur in the knee joint after total knee replacement. Not only is the 3DKnee designed to provide a wider range of motion and greater stability than other knee prostheses, its revolutionary design is also intended to minimize the stresses that have traditionally led to the premature deterioration of most available implants. As a result, the 3DKnee should have a longer life expectancy than other devices, making it ideal for younger patients.[1]

Also, as part of this first phase, DJO Surgical will bring to the United States Lima Corporate’s Revision Hip Stem and Acetabular Cups System, including Trabecular Titanium.

Trabecular Titanium Logois an innovative multi-planar hexagonal cell structure imitating the cell structure of the trabecular bone. Its morphology and dimensions have been optimized to improve vascularization and therefore maximize osteointegration. The low rigidity of the Trabecular Titanium structure fosters the transmission of physiological loads from implant to bone. It is far more resistant compared to trabecular bone, therefore it can be used as the ideal filler/support structure for bone in growth.

Clinical studies have demonstrated excellent osteointegration and a BIC (Bone Implant Contact) of 95% in 26 weeks. Trabecular Titanium can be applied in the most diverse prosthetic implants, from initial and revision Acetabular cups to cemented cup and metal back glenoids. [2]

The relationship between these two outstanding and innovative companies will allow each of them to leverage one another’s product portfolio and increase their product offerings to better serve their customers. Les Cross president and chief executive officer, commented, “It would be difficult to find a better match between two total joint companies. Our product lines and geographic strengths are quite complimentary. We are excited to be able to provide each other products that will allow both companies to grow in their respective market spaces.” It is expected that both companies will begin rolling out these initial products in late 2009.

Stefano Alfonsi, CEO for Lima Corporate , commented, “At Lima we believe that collaboration is great source of innovation and customer service; we believe that connecting good people and sharing ideas across the globe gives us the ability to anticipate the customer demand. This collaboration allow us to serve a worldwide customer base.

We are mastering technology and materials for orthopaedics and we are confident than US market will also welcome our capability. At the same time we are really enthusiastic to be able to provide to our European customers a clinically proven and innovative knee system provide by DJO Surgical”.

About DJO Incorporated

DJO 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. Our products 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 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™, DJO Surgical, Empi®, Chattanooga Group™, Cefar®-Compex® and Ormed®. For additional information on the Company, please visit www.djortho.com.

About Lima Corporate

Lima Corporate is the Italian International Leader of Orthopaedics and Traumatology.

For over 60 years Lima has been present in the medical field with implantable prosthesis substitutive of bone articulations for knee, hip, shoulder and minor joints arthroplasty. Lima Corporate project is to produce a complete system of interchangeable modules to better adapt the implant to each patients needs, thus reducing surgery time and improve functional rehabilitation.

Lima Corporate core business combines its experience in the orthopaedic field with its know-how in the area of implantable materials of biomechanics; it applies distinct concepts such as modularity and the use of innovative materials like Trabecular Titanium and bioceramics. Strongly oriented to international, Lima Corporate has a company structure which consists in three modern facilities in Italy - in the regions of Friuli Venezia Giulia, Emilia Romagna and in Sicily - in addition to its 11 Subsidiaries.

Since 2008 the Company Hit Medica is part of Lima Corporate. Hit Medica offers a wide range of trauma, hand and foot surgery products and is continuously committed to the research of innovative procedures, giving the customer the possibility to choose the best surgical solution for every patient. Hit Medica operates in Italy and worldwide through a network of company representatives and exclusive distributors. For additional information on the Company, please visit www.lima.it.

Media Contact:

Lima Corporate
Anna Callea
Communication Assistant
+39 0432 945511
anc@lima.it

References

[1] Data on file at DJO Surgical
[2] Data on file at Lima Corporate


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Hip, Knee, Trauma, Upper limb, Foot & Ankle, Paediatrics, Oncology, Spine, Arthroplasty, General