Information that must be provided to patients with implants, pursuant to Article 18(1) of Regulation (EU) 2017/745
SILKTOE JOINT PROSTHESIS
1) WARNINGS REGARDING INTERFERENCE WITH MEDICAL EXAMINATIONS AND EXTERNAL INFLUENCES
The materials chosen for the manufacture of this device are not particularly susceptible to environmental influences. They also mitigate risks in environments characterised by electromagnetic fields. However, the device has not been evaluated for safety and compatibility with magnetic resonance imaging (MRI) equipment. In particular, it has not been tested for aspects relating to overheating, displacement and the production of unwanted images ("artifacts") that are displayed in the MR image. The safety of the device in an MR environment is unknown.
2) EXPECTED LIFESPAN AND FOLLOW-UP
It is not possible to define the life span of the device in advance, as this 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 operation. Others are related to the patient, such as the biological and physiological response to the implant, the patient's clinical condition, their behaviour particularly with regard to weight gain, heavy lifting and high levels of physical activity. A review of the clinical literature shows a survival rate of at least 94% at 5 years 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 lifetime of the device.
3) 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 the surgeon's instructions regarding movement and activity restrictions until complete healing;
- if you notice any obvious stiffness or excessive elasticity in the joint, excessive pain or symptoms of infection, contact the facility where the implant was performed;
- the device helps to relieve pain and restore function to the first metatarsophalangeal joint; however, patients are advised not to engage in physical activities that may put excessive strain on the joint.
The device consists of two components:
- the spacer, manufactured using a silicone elastomer (polydimethylsiloxane - CAS code: 63394-02-5) reinforced with amorphous silica,
- the grommets, manufactured using the titanium alloy 'Ti6Al4V' in accordance with EN ISO 5832-3. In particular, a type of alloy with more restrictive oxygen and iron values, known as 'extra low interstitial' (ELI), is used in accordance with ASTM F136. The chemical composition of the alloy, as defined by the above 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 | Residue |