Project Description

GENTAFIX®3 & 3MV

PMMA acrylic cement with antibiotic

GENTAFIX 3 & 3 MV® is a PMMA acrylic bone cement loaded with gentamicin for fastening prostheses to the bone during orthopaedic surgery.

GENTAFIX 3® is a low viscosity, self-hardening cement recommended for application using a syringe.

GENTAFIX3 MV® is a ready-to-use, medium viscosity cement, specifically developed for the latest medical cementation techniques.

GENTAFIX 3 & 3 MV® contains an aminoglycoside antibiotic, gentamicin.  Its wide spectrum of activity makes it effective against the majority of bacteria responsible for infections associated with orthopaedic surgery.

It comes in the form of an ampoule of sterile liquid monomer and a sachet of sterile polymer powder.

The product complies with the ISO 5833 Standard.

ADVANTAGES

  • Significant salt release
  • Easy mixing
  • Reduced infection
  • Suitable viscosity
  • Long application time
  • Optimal waiting time
GENTAFIX3 & 3 MV® is a bone cement with gentamicin indicated for arthroplasty operations of the hip, knee and other joints, for stabilising plastic and metallic prosthetic implants on bone in reconstruction surgery and for reoperations on infected arthroplasties.  These cements are indicated for stabilising prosthetics by second intention, for changing infected prosthetics in two stages after initially treating the infection.
Hardening

The maximum temperature of 68°C reached during the polymerisation of GENTAFIX3 & 3 MV® lies well below that required by the ISO 5833 Standard, thus reducing the danger of bone necrosis.

Physical properties 

The physical properties of GENTAFIX3 & 3 MV® cement largely exceed the requirements of the ISO 5833 Standard, ensuring perfect long-term physical integrity.

In-vitro release rates

GENTAFIX3 & 3 MV® contains 1g of gentamicin base, a quantity optimised to ensure prolonged release over time and thus prevent post-operative infections.  Starting from the hours immediately after the operation, the period in which the risk of infection is greatest, there is a sizeable and rapid release of gentamicin.

Description Reference
Non-sterile bowl and spatula x 10 T060404
Long cannula syringe T060405
Oblong cannula syringe T060402
VACUUKIT® T060416

References

Description Reference
GENTAFIX 3® 40g T040340G
GENTAFIX3® MV 40g T040341G

Certifications

CE 2797
Class: III

Bibliography

Wahlig, H. and E. Dingeldein (1980). « Antibiotics and bone cements. Experimental and clinical long-term observations. » Acta Orthop Scand 51(1): 49-56.
Lindberg, L., R. Onnerfalt, et al. (1991). « The release of gentamicin after total hip replacement using low or high viscosity bone cement. A prospective, randomized study. » Int Orthop 15(4): 305-9.
Jiranek, W. A., A. D. Hanssen, et al. (2006). « Antibiotic-loaded bone cement for infection prophylaxis in total joint replacement. » J Bone Joint Surg Am 88(11): 2487-500.
Block, J. E. and H. A. Stubbs (2005). « Reducing the risk of deep wound infection in primary joint arthroplasty with antibiotic bone cement. » Orthopedics 28(11): 1334-45.