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spacer antibiotic
SYNICEM™ SHOULDER SPACER

Preformed, antibiotic loaded shoulder spacer to maintain space and aid treatment of infection

Specifically designed to support your management of infection in shoulder revision

Combining convenience, structural uniformity and stability, whilst delivering a high local concentration of gentamicin.
SYNICEM™ SHOULDER SPACERS reliably stabilise the shoulder, while maintaining the articular space, limb length and muscle structure.6

  • Precision engineered for consistency and structural uniformity
  • Designed for dynamic movement and stability
  • Preloaded with gentamicin to aid treatment of infection
  • Case-by-case flexibility and time-saving

Precision engineered for consistency and structural uniformity

Strictly controlled manufacturing conditions minimise the risk of mechanical failure by eliminating unwanted variation in the shape and
structural integrity of the base material.

  • Perfectly spherical and polished finish of the humeral head prevents bone stock wear6
  • Intra-operatively prepared spacers are time consuming to make and prone to fracture.1

Designed for dynamic movement and stability

Designed to maintain articular space, limb length and muscle structure after removal of the original implant.6

  • Uniform stainless-steel core to increase mechanical resistance
  • Suture anchor points allow rotator cuff to be secured to the spacer

Preloaded with gentamicin to aid treatment of infection

The spacer yields a high local concentration of gentamicin while maintaining low systemic levels to aid the treatment of infection.6

Case-by-case flexibility and time-saving

A comprehensive range of sizes and styles provide case-by-case flexibility, with a reusable spacer tray available to ensure you select the correct size every time.6

  • No moulding required

 

References and regulatory statements

1. Craig, A., King, S.W., van Duren, B.H., Veysi, V.T., Jain, S., & Palan, J. (2022). Articular spacers in two-stage revision arthroplasty for prosthetic joint infection of the hip and the knee. EFORT Open Reviews, 7, 137 – 152.
2. Ocguder, A., Firat, A., Tecimel, O., Solak, S., & Bozkurt, M. (2010). Two-stage total infected knee arthroplasty treatment with articulating cement spacer. Archives of orthopaedic and trauma surgery, 130(6), 719–725.
3. Dunne, N., Hill, J., McAfee, P., Todd, K., Kirkpatrick, R., Tunney, M., & Patrick, S. (2007). In vitro study of the efficacy of acrylic bone cement loaded with supplementary amounts of gentamicin: effect on mechanical properties, antibiotic release, and biofilm formation. Acta orthopaedica, 78(6), 774–785.
4. Bertazzoni Minelli, E., Benini, A., Magnan, B., & Bartolozzi, P. (2004). Release of gentamicin and vancomycin from temporary human hip spacers in two-stage revision of infected arthroplasty. The Journal of antimicrobial chemotherapy, 53(2), 329–334.
5. Moerenhout, K., Steinmetz, S., Vautrin, M., Picarra, S., Udin, G., & Borens, O. (2021). Economic advantage of ‘self-made’ antibiotic-loaded spacer compared to prefabricated antibiotic-loaded spacer and spacer molds in two-staged revision arthroplasty. Acta orthopaedica Belgica, 87(3), 557–562.
6. Synimed, Synicem Instruction for Use.

For indications, contraindications, warnings and precautions see Instructions for Use. Concurrent use of locally administered antibiotics may affect setting time, absorption characteristics and/or bone formation. It is the surgeon/healthcare professional’s responsibility to give due consideration to the details in the medicinal product marketing authorization in deciding whether it is appropriate for the patient under his/her care. The relevant Summary of Product Characteristics (SmPC) must be consulted. The type and dose of medicinal substance should also be assessed according to the individual patient’s clinical circumstance.
This brochure may include the use of STIMULAN or techniques that go beyond the current clearance / approval granted by the relevant regulatory authority. Please contact your local representative for further information.

©2023, Biocomposites, STIMULAN are trademarks/registered trademarks of Biocomposites Ltd. Synimed and Synicem are trademarks/registered trademarks of Synergie Ingénierie Médicale S.A.R.L. All rights reserved. No unauthorised copying, reproduction, distributing or republication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.

Patents granted: GB2367552, EP 1204599 B1, US 6780391, EP 2594231 B1, US 8883063, CN ZL201210466117.X, GB2496710, EP 3058899 B1, US 10390954, US 10,588,748,CN ZL201610089710.5
Patents pending: GB1502655.2, GB1704688.9, EP 18275044.8, US 15/933936, CN 108619579A

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