Recommendations for Handling Defective Surgical Implant

Have you just identified a defective surgical implant?

Has your first concern been for the health of any affected patient(s)?

Have you documented the clinical findings indicating the defect and all subsequent actions?

Have you preserved any evidence in a secure location with chain of custody?

Have you identified which patients may be affected?

• the government regulator (US Food and Drug Administration)?

• hospital administration?

• the implant manufacturer?

• the American Academy of Orthopaedic Surgeons?

• the patient(s) affected?

• your malpractice carrier?

• fully inform the affected patients about the problem?

• perform surveillance for all patients affected?

• identify and treat complications?

• replace the defective part if indicated?

• cover the expenses involved?