The first concern must be the health of the affected patient(s).
Review and secure the relevant evidence:
(1) Document the clinical findings indicating the defect and all subsequent actions.
(2) Preserve the evidence in a secure location with chain of custody.
(3) Identify which patients may be affected.
Notifications:
(1) government regulator (US Food and Drug Administration)
(2) hospital administration
(3) manufacturer
(4) American Academy of Orthopaedic Surgeons
(5) patients affected
(6) malpractice carrier
Develop an action plan to:
(1) Fully inform the affected patients about the problem.
(2) Plan surveillance for all patients affected.
(3) Identify and treat any complication.
(4) Replace the defective part if indicated.
(5) Cover the expenses involved.
