Standards for a good warranty for hip and knee implants (2-25-14)
A fair warranty should be given to patients as part of the implant procedure and should meet the following basic requirements:
- Covers the implant for a specified period of time
- Covers full replacement costs of a flawed device, including the device, surgeon and hospital costs as well as the related patient out of pocket costs.
- Does not require the failed device be replaced with the same product or a product from the original device maker if the product has been recalled by the FDA or the company, is the subject of FDA warnings, is under investigation by the FDA or if the product is no longer being sold by the company.
- Establishes a clear system for patients to use, including a toll-free number and a registration number to track the claims process, with physicians charging the device company, not the patient.
- Does not require the patient pay out-of-pocket expenses; for example, the patient should not have to pay the device maker or surgeon first and get reimbursed later.
- Provides the patient with full information concerning a warranty claim denial and provides a process to allow the patient to appeal the decision.
- Does not limit or eliminate a patient’s right to sue if they use the warranty.
- Does not disqualify patients across the board because they have specific diseases or illnesses that are not related to the failure of a device.
- Does not disqualify patients for normal activities, including falls.
- Does not disqualify patients due to information that is not routinely available to them, such as information that is on the device packaging or placed into their medical records and not routinely provided directly to the patients in the course of getting the implant.