Consumers: Report Adverse Events with Metal Hips to FDA

A patient with a metal-on-metal or any hip replacement that causes symptoms or problems requires that the individual become his/her own best advocate.

Make an appointment with your surgeon if you’re having problems with your implant.

First, make an appointment with an orthopedic surgeon for evaluation which includes not just a physical exam but an examination of fluid around the joint/ soft tissue and blood tests looking for the presence of metal ions in the blood and tissue surrounding the implant.

It’s important for patients to learn how to report their own adverse event into the Food and Drug Administration’s MAUDE database. Warning – it is not easy.

MAUDE stands for Manufacturer and User Facility Device Experience (MAUDE) data. It is the best way for the FDA to ascertain the number of patient injuries since there is no U.S. data registry for implants, which is a huge safety loophole. There are other voluntary reporting systems such as MedWatch and the MedSun surveillance network.

Most people do not know the make and model of their device. This can be obtained through medical records and documents sent to Medicare or insurance for reimbursement, surgical notes and nurse’s notes.

At this time it is easier to track an automobile recall through the vehicle’s VIN # than an implantable medical device.

Because of the difficulty in using MAUDE and the fact that there are no sanctions if a device maker fails to report an injury, MAUDE is suspected of reflecting just 1 to 10% of real world events, according to the General Accounting Office.

You can file an Adverse Event Report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online:

• By phone- 1-800-FDA-1088
• By FAX – obtain a fillable form online and print it out and fax it to 1-800-FDA-0178
• By mail – or mail it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787

The MedWatch Online Voluntary Reporting Form (3500) is here.

You may want to look up Recent Medical Device Recalls here.

The patient can find the MAUDE database here.

Look up the Product Problem, Product Class, Brand Name, Manufacturer and event type from your surgical notes. Be sure to pull up the small calendar icon to put in the range of dates you are looking at and enter the number of Records per Page Report at 50.

For example, if you are looking up a Stryker Rejuvenate Hip component, the company name is spelled, Stryker Orthopaedics, Brand Name may be Unknown rejuvenate modular neck. Consumers can find more information at the FDA’s Office of Surveillance and Biomatrics by email at: phann@fda.hhs.gov or by phone at 301-796-6640.