Adverse reaction to metal debris in a case series of hip arthroplasty: A future scenario for the allocation of liability between manufacturer and medical personnel.

Abstract

Adverse reactions to metal debris are inflammatory-necrotic changes that can occur in individuals with joint prostheses, particularly hips. They are triggered by the release of metal debris at both the periprosthetic tissue level and systemically. This was internationally recognised by 2012: several recommendations followed. Patients were advised to undergo careful clinical, laboratory and radiological follow-up with the potential need for prosthetic revision surgery. Concurrently, the primary manufacturers issued safety notifications and began recalling some prosthetic devices from the market. Notwithstanding, prosthetic implants with metal components continue to be widely used due to their favourable risk-benefit profile. We examined the cases of three patients whose hip arthroplasty had metal-type implants. Following the development of adverse reactions to metal debris, they underwent early prosthetic revision and even surgery to remove the prosthesis and clean up metal debris. Consequently, the patients requested a medico-legal evaluation to obtain compensation for the damage suffered. The investigations conducted in these three cases resulted in different allocations of liability: one to the manufacturing company, one to the healthcare professionals who treated the patients, one shared by both. This illustrates that, even after the risk has been identified, it remains a pertinent issue and provides insight into potential future scenarios regarding professional liability cases of a similar nature.