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Silktoe

MTP1 silicone prosthesis.

/ Patient info

Silktoe

MTP1 silicone prosthesis.

Information to be provided to the patient bearing the implant, in accordance with Article 18(1) of Regulation (EU) 2017/745

WARNINGS REGARDING INTERFERENCE WITH MEDICAL EXAMINATIONS AND EXTERNAL INFLUENCES

The materials chosen for this device are not particularly susceptible to environmental influences. They also represent a risk mitigation measure associated with environments characterized by electromagnetic fields. However, the device has not been evaluated for safety and compatibility with magnetic resonance imaging (MRI) equipment. Specifically, it has not been tested for aspects related to overheating, displacement, and the production of unwanted images (“artifacts”) that appear in MRI images. The safety of the device in an MRI environment is unknown.

EXPECTED USEFUL LIFE AND FOLLOW-UP

It’s impossible to define the device’s lifespan a priori, as it depends on the interaction of various factors. The manufacturer is responsible for some of these, while others, such as the implantation technique, are the responsibility of the surgeon performing the procedure. Still others are patient-specific, such as the biological and physiological response to the implant, their clinical condition, and their behavior regarding weight gain, heavy lifting, and high levels of physical activity. Clinical literature shows a five-year survival rate of at least 94% for similar devices.

The post-operative protocol is defined at the sole discretion of the surgeon, who plans it based on their knowledge and the individual patient’s condition. BRM Extremities recommends follow-up visits at 1 month, 6 months, and 12 months after surgery, followed by annual check-ups for the life of the device.

INFORMATION FOR SAFE USE

In addition to the possible side effects of the implant communicated by the surgeon, the patient must also take into account the following:

  • Do not subject the operated anatomical area to excessive mechanical stress;
  • Strictly follow your surgeon's instructions regarding movement and activity restrictions required until you are fully healed;
  • If you experience obvious stiffness or excessive elasticity in the joint, excessive pain, or symptoms of infection, contact the facility where the implant was performed;
  • The device provides pain relief and restores function to the metatarsophalangeal joint of the first toe; however, patients are advised not to perform physical activities that may place excessive stress on the joint.

DEVICE COMPOSITION

The device consists of two components:

  • The spacer, made using a silicone elastomer (polydimethylsiloxane - CAS code: 63394-02-5) reinforced with amorphous silica,
  • The grommets are made using the titanium alloy "Ti6Al4V" compliant with EN ISO 5832-3. Specifically, a type of alloy with more restrictive oxygen and iron values is used, known as "extra low interstitial" (ELI) compliant with ASTM F136.

The chemical composition of the alloy, as defined by the above-mentioned standards, is as follows:

ELEMENT

% (M/M)

ELEMENT

% (M/M)

Al

5.5 – 6.5

C

≤ 0.08

V

3.5 – 4.5

N

≤ 0.05

Fe

≤ 0.25

H

≤ 0.012

O

≤ 0.13

Ti

Balance

ELEMENT

Al

V

Fe

O

% (M/M)

5.5 – 6.5

3.5 – 4.5

≤ 0.25

≤ 0.13

ELEMENT

C

N

H

Ti

% (M/M)

≤ 0.08

≤ 0.05

≤ 0.012

Balance