cemSys® PMMA Bone Cement Product information cemSys®
The first total hip replacement using a PMMA cement took place in the 1950’s. Since then cemented implants have become a gold standard in total hip and knee arthroplasty. Today surgeons can choose between a variety of cements with different viscocities, available with and without added antibiotics.
cemSys® fulfils all requirements of a proven high quality bone cement
• More than 10 years of clinical history • Mechanical properties superior to the International ISO 5833 standards • Two different viscosities for various applications • Short waiting time and an efficient application time • Stable packaging, liquid in an ampule and powder in a bottle
2 Mathys Ltd Bettlach • Robert Mathys Strasse 5 • P. O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com Chemical composition of cemSys®
Liquid (ml)
cemSys® cemSys® Liquid cemSys® 1 cemSys® 3 genta 1 genta 3 Methyl methacrylate 12.9 12.9 14.7 14.7 Butyl methacrylate 2.1 2.1 2.4 2.4 N, N-dimethylptoluidine 0.4 0.4 0.4 0.4 Hydroquinone (ppm) 20 20 20 20 Total Content 15.4 15.4 17.5 17.5
Powder (gram)
cemSys® cemSys® Powder cemSys® 1 cemSys® 3 genta 1 genta 3 Polymethyl methacrylate 35.0 35.3 34.9 35.2 Benzoyl peroxide 1.0 1.0 1.1 1.1 Barium sulfate 4.0 4.0 4.0 4.0 Gentamicin – 0.5 – 0.5 Total Content 40 40.8 40 40.8
Mathys Ltd Bettlach • Robert Mathys Strasse 5 • P. O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com 3 [µg] 150
100
50
10
1
0 1 2 3 4 5 6 7 8 9 10
[MPa] 100
80
60
40
20
0
[MPa] 100
80
60
40
cemSys20 ®
0
The peak reaction temperature Low hardening temperature of cemSys genta The polymerization of PMMA bone cements is an exo- thermic chemical reaction.[mm] As the cement starts to [°C] ISO 5833 harden, the temperature10 will increase as a result of the 90 ( 2002 ) 90° C polymerization process. This could potentially lead to tissue necrosis, which is why the ISO 5833 (2002) stand- ard places a limit of 90°8 C on the hardening tempera- 70 ture of bone cements. The peak reaction temperature of cemSys is well within this limit. 6 67°C 79°C 50 4
30 2 1
0 0 cemSys® cemSys® genta 1 genta 3
cemSys® 1 Different viscosities to match surgeon’s preference
high viscosity Viscosity is an essential handling property for surgeons.
Viscosity To match the needs and preferences of different sur- geons, we supply both a high and low viscosity bone cements. cemSys 3 is our low viscosity bone cement, which is initially more liquid, while cemSys 1 is our high viscosity cement, which is initially slightly thicker. Time The products are available with and without antibiot- ics. All cements comply with the International ISO 5833 standard for PMMA bone cements which define the cemSys® 3 physical, mechanical, packaging and labelling require- ments.
low viscosity Viscosity
Time
4 Mathys Ltd Bettlach • Robert Mathys Strasse 5 • P. O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com [µg] 150[µg] 150 100 100
50 50 10 10 1 1 ® 0 cemSys 0 1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 10
Mechanical properties
Compressive[MPa] strength 100[MPa] 100
80 80 93.7 90.8 98.5 99.1
60 60 ISO 5833 ( 2002 ) 70 MPa 40 40
20 20
0 0 cemSys® 1 cemSys® cemSys® 3 cemSys® genta 1 genta 3
Bending strength [MPa] 100[MPa] 100 80 80
60 65.4 63.9 67.5 65.7 60 ISO 5833 40 ( 2002 ) 40 50 MPa
20 20
0 0 cemSys® 1 cemSys® cemSys® 3 cemSys® genta 1 genta 3
[mm] [°C] 10[mm] [°C] 90 10 90 8 8 Mathys Ltd Bettlach • Robert Mathys70 Strasse 5 • P. O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com 5 70 6 6 50 50 4 4 30 30 2 2 1 1 0 0 0 0 cemSys®
Antibiotic bone cements Release of gentamicin
Our cemSys genta products include some added antibi- In Europe, the most frequently used bone cements – otics for local antibiosis. To ensure effective antibiosis including our own cemSys genta – have Gentamicin without compromising the mechanical strength of the added to them. Gentamicin is an antibiotic which cov- product, we limit the amount of antibiotics to about ers approximately 75 % of all bacteria-based pathogens. 3 – 4 % of the total powder volume. Its addition to bone cements prevents the adherence of bacteria to the cement surface and surrounding tissue, reducing the risk of bacterial growth and infection.
cemSys genta starts with a high initial release of anti- biotics, which steadily decreases over time.
Antibiotic spectrum of Gentamicin (Förster et al. 1988)
in ic m 33.5% Pseudomonas a t n Enterobacteriaceae e 33.5% 23.5% G Staphylococcus Staphylococcus coag. negative
Streptococcus
11.5% 9% Anaerobic Other
4.5% 4% 14%
6 Mathys Ltd Bettlach • Robert Mathys Strasse 5 • P. O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com cemSys®
Antibiotic bone cements
The release of Gentamicin over time
[µg] 150
100 cemSys® genta 1
cemSys® genta 3 50
10
1
0 Time in days 1 2 3 4 5 6 7 8 9 10
[MPa] Ordering100 information
80
Item no. Description 60 52.34.0080 cemSys 1 (1 x 40 g) 52.34.0081 cemSys 3 (1 x 40 g) 40 52.34.0082 cemSys genta 1 (1 x 40 g) 52.34.0083 cemSys genta 3 (1 x 40 g) 20
For more information about our product portfolio, 0 please contact your local dealer
[MPa] 100
80
60
40
20
Mathys Ltd Bettlach • Robert Mathys Strasse 5 • P. O. Box • 2544 Bettlach • Switzerland • www.mathysmedical.com 7 0
[mm] [°C] 10 90
8
70 6
50 4
30 2 1
0 0 Australia Mathys Orthopaedics Pty Ltd Japan Mathys KK Lane Cove West, NSW 2066 Tokyo 108-0075 Tel: +61 2 9417 9200 Tel: +81 3 3474 6900 [email protected] [email protected]
Austria Mathys Orthopädie GmbH New Zealand Mathys Ltd. 2351 Wiener Neudorf Auckland Tel: +43 2236 860 999 Tel: +64 9 478 39 00 [email protected] [email protected]
Belgium Mathys Orthopaedics Belux N.V.-S.A. Netherlands Mathys Orthopaedics B.V. 3001 Leuven 3905 PH Veenendaal Tel: +32 16 38 81 20 Tel: +31 318 531 950 [email protected] [email protected]
France Mathys Orthopédie S.A.S P. R. China Mathys (Shanghai) Medical Device Trading Co., Ltd 63360 Gerzat Shanghai, 200041 Tel: +33 4 73 23 95 95 Tel: +86 21 6170 2655 [email protected] [email protected]
Germany Mathys Orthopädie GmbH Switzerland Mathys (Schweiz) GmbH «Centre of Excellence Sales» Bochum 2544 Bettlach 44809 Bochum Tel: +41 32 644 1 458 Tel: +49 234 588 59 0 [email protected] [email protected] Hotline: +49 1801 628497 (MATHYS) United Kingdom Mathys Orthopaedics Ltd Alton, Hampshire GU34 2QL «Centre of Excellence Ceramics» Mörsdorf Tel: +44 8450 580 938 07646 Mörsdorf/Thür. [email protected] Tel: +49 364 284 94 0 [email protected]
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