Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.Reports to the FDA about adverse events related to metal-on-metal hip systems include, but are not limited to: pain, malposition, adverse local tissue reaction, metallosis, hypersensitivity (allergy), loosening, and dislocation.
All device manufacturers must comply with Medical Device Reporting (MDR) Regulations of 21 CFR, Part 803.
When possible, please report all information obtained from retrieval analyses. This may include, but not limited to: histology of the surrounding tissue, adverse wear patterns and the range of wear particle diameter size, length and aspect ratio.
If a physician suspects an adverse event with a metal-on-metal device, FDA encourages you to file a voluntary report through our MedWatch, the FDA Safety Information and Adverse Event Reporting program. To help us learn as much as possible about the adverse events associated with metal-on-metal hip implants, please include the following information in your reports, if available:
- Date of implantation
- Date of implant removal (if applicable)
- Clinical cause for revision (if available)
- System components affected by the adverse event
Patients that have been evaluated by a physician and are experiencing an adverse event as a result of their metal-on-metal hip system may also file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) via e-mail at email@example.com or by phone: 800-638-2041 (toll-free) or 301-796-7100.