MicroPort Orthopedics provides an Implant Card with each device. The intention of the Implant Card is to enable the patient receiving the implant to:

a. Identify the implanted device
b. Identify themselves as requiring special care in relevant situations (i.e., security checks, emergency situations, etc.)

In meeting this intent, MicroPort Orthopedics requests the healthcare provider complete the following instructions in order to provide the patient with a fully compliant Implant Card.

1. Ensure that the information on the back of the International Implant Card matches the information on the product label.
a. If the information does not match, please contact MicroPort Orthopedics by one of the following methods:
i. Telephone:
Europe: +44 1244.572120
United States: 866.872.0211

ii. Email: complaints@ortho.microport.com
The following information will be required to be submitted:
• Reporter’s Name
• Reporter’s Address
• Reporter’s Phone Number
• Product Number
• Lot Number
• Detailed description of the incident
2. Using a ball point pen or a felt tip permanent marker (i.e. Sharpie felt-tip pen), complete the blank spaces on the Front of the International Implant Card. See example below to distinguish the Front and Back of the card.
Patient’s name
Date of surgery
Name and address of doctor or healthcare center

 

Front
Back

 

3. The Implant Card should be provided to the patient.
Symbols Glossary
Symbol Title [Additional Explanation] Reference Number/ StandardExplanatory Text from Standard
Medical device Indicates the item is a medical device
Translation Indicates that the original medical device information has undergone a translation which supplements or replaces the original information
Batch code Indicates the manufacturer’s batch code so that the batch or lot can be identified.
Catalogue number Indicates the manufacturer’s catalogue number so that the medical device can be identified.
Manufacturer Indicates the medical device manufacturer.
MR Conditional Indicates an item that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. If applicable, conditions can be found within the package insert or at www.ortho.microport.com/ifus.
Unique Device Identifier Indicates a barcode as containing Unique Device Identifier information
Patient identification Indicates the identification data of the patient.
Patient information website Indicates a website where a patient may obtain additional information on the medical product.
Health care center or doctor Indicates the address of the health care center or doctor where medical information about the patient may be found.
Date Indicates the date that information was entered or a medical procedure took place.
#Unless otherwise noted, all symbols are sourced from ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements