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Some implant defects might not be enough for an FDA recall

Let us say that you had a recent hip or knee replacement. Everything went well for a year or so, but now some issues with the device have developed and you believe a component might be defective.

The FDA has three categories for device recalls, but not everything about an implantable device is covered and a manufacturer may face a lawsuit as a result.

The FDA classifications

The Food and Drug Administration breaks recalls down this way:

  •         Class I: This is the most serious classification. There is considerable probability that the use of the product or device could cause serious health issues or death.
  •         Class II: These recalls stem from a remote possibility that use of the product will cause serious health consequences.
  •         Class III: Products in this category are unlikely to cause serious health issues.

Case in point

A case study illustrates the recall conundrum. A 58-year-old woman had total knee replacement surgery. Five years later, she complained that the knee felt loose and she heard a “popping” sound. She was examined and underwent an arthroscopy, during which the surgeon replaced a plastic post, reporting that the post had not failed, but that some wear was apparent. A year later, the patient fell and blamed the incident on the replaced post. She asserted that the post was defective; that the doctor knew it and had kept that information quiet.

The outcome

The doctor denied the accusation, saying she had never received an alert or had otherwise been informed of a defect in the post. The patient filed a lawsuit, after which the manufacturer’s representative told the doctor that a defect in the post had indeed been found—however, the FDA did not consider it significant enough to warrant a recall.  

A patient has rights

An experienced attorney will tell you that medical devices do not always work as they should. That the FDA does not always flag a defective part for recall is an additional complication, and patients could suffer the consequences. If you believe your hip or knee replacement is in some way defective, it bears looking into. Your rights as a patient must be protected.

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