AUDIENCE: Orthopaedic surgery, Radiology, Risk Manager
ISSUE: FDA notified healthcare professionals that it is providing updated safety information and recommendations to patients and health care providers, based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting.
BACKGROUND: In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can be released from other parts of the implant where two implant components connect. Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body. Presently, the FDA does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects. In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.
RECOMMENDATIONS: Please see the Safety Communication for detailed recommendations for surgeons before the surgery and during patient follow-up, for imaging the implant, monitoring and assessing metal ion levels and considerations for device revision. Recommendations are also provided for patients considering hip implants and those with metal-on-metal hip implants.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Reports 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. To help FDA 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the complete MedWatch Safety Alert, including a link to the Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm336069.htm
