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Implant passport: what it is and why every patient receiving an implant should have one

What an implant passport contains, how it differs from a discharge summary, and why it matters for device-recall safety and downstream care.

4 min read·807 words·FK 9.9·Updated

By The Treatment Registry Editorial Team · Editorial team — medical-tourism due-diligence registry · COI: The registry does not accept payment for listings, referral commissions, or sponsored content.

An implant passport — sometimes called an implant card, device card, or patient-held device record — is a small printed document a patient receives after any procedure that places a permanent medical device in their body. Implants include breast augmentation implants, hip and knee replacements, dental implants, heart valves, pacemakers, cochlear implants, mesh, intraocular lenses, and any other long-dwelling device. This guide explains what should be on the implant passport, why it matters, and what to do if it isn't provided.

What the implant passport contains

A defensible implant passport contains, at minimum:

- **Patient identifier.** Patient name, date of birth, hospital or clinic identifier - **Device manufacturer.** The legal entity that manufactured the device - **Device brand name.** As marketed - **Device model or product code.** Specific to the variant placed - **Lot number / serial number.** Specific to the actual device placed in this patient - **Date of placement.** The day of surgery - **Implant site.** Where on or in the body - **Surgeon name and registration number.** Responsible clinician - **Facility name and licence.** Where the surgery happened - **Notes specific to the device.** Such as expected lifetime, MRI compatibility, or device-specific care - **Contact for device recall.** Manufacturer's regulatory affairs contact

In some jurisdictions the implant passport must also include a unique device identifier (UDI) under medical-device regulations. Europe's MDR and the US FDA both require UDIs on certain device classes.

Why the implant passport matters

**Device recalls.** Medical devices are recalled when post-market surveillance identifies a safety problem. Recall communication is targeted at clinicians who placed the device and at patients who hold the device. A patient who does not have the implant passport cannot be notified individually if the device is recalled.

**Future imaging and procedures.** Some implants are MRI-incompatible, electrically active, or interact with other devices. A future scan or procedure may need to be modified to accommodate the device. Without the implant passport, the future clinician is working blind.

**Insurance and warranty claims.** Some device manufacturers warranty their devices for defined periods. The patient cannot claim under the warranty without the lot number.

**Joint and device registries.** Many countries operate national registries for high-volume implants (joints, breast implants, mesh). Registry inclusion is the strongest defence against undetected device failure. Patients with the implant passport can confirm they are on the relevant registry; patients without it usually are not.

**Litigation.** Where a device class is the subject of a class action (e.g. PIP breast implants, Stryker hip replacements, Essure contraception), claimants need lot-level evidence. Patients without the implant passport often cannot join the action.

How to obtain the implant passport

The passport should be provided at discharge alongside the operation report. If it is not:

- Ask the surgeon or discharging clinician directly, in writing - Refuse to sign discharge until provided, or photograph it before leaving - If the clinic refuses or claims the information is not retained, contact the clinic's quality manager or hospital director - If still not provided, file a complaint with the national medical council or hospital regulator; refusal to provide implant identity is a disciplinary matter in most jurisdictions

What to do with the implant passport once received

- **Photograph it.** Store a copy on your phone and in your email. - **Give a copy to your home-country doctor** at the first follow-up appointment. Have it added to your home medical records. - **Register with the manufacturer.** Some manufacturers operate patient registries; registration enables direct recall notification. - **Register with the national implant registry** if your home country operates one (e.g. UK Breast and Cosmetic Implant Registry, Australian Orthopaedic Association National Joint Replacement Registry). - **Carry the passport when you travel.** Border medical incidents are easier to manage with the device information to hand.

Red flags around implants

- The clinic refuses to name the implant brand or model before surgery - The implant is described only as "premium" or "high-quality" without a manufacturer - The implant passport is not provided at discharge and the clinic resists providing it later - The brand named is not registered with the patient's home-country regulator - The lot number is missing or marked "not available"

Questions to ask before the procedure

1. What is the brand, model, and manufacturer of the implant that will be placed? 2. When will the lot number be available — at surgery or at discharge? 3. Will I receive a written implant passport at discharge? 4. Is the implant registered with the national device registry? 5. What recall-notification mechanism applies if the device is recalled in the future?

This guide is educational. It does not constitute medical or legal advice. If you have already received an implant without an implant passport and the device has been the subject of a recall, seek qualified clinical advice promptly.

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