[Causality analysis of a low-viscosity bone cement in orthopaedic surgery following serious adverse events]. / Analyse d'imputabilité d'un ciment basse viscosité en orthopédie suite à la survenue d'événements indésirables graves.

ABSTRACT

OBJECTIVES: Low-viscosity bone cement impregnated with gentamicin is frequently used to fix femoral prostheses. Three cardiac arrests occured successively during cementoplasty oh hip replacements, leading to the death of two patients. The objective of this study is to describe the actions undertaken to establish a potential link between the use of the bone cement and the occurrence of these serious adverse events (SAE). METHODS: A mortality and morbidity review was organised in order to study the causality of bone cement and to propose improvement actions, following 3 considered SAE associated to materiovigilance reporting. RESULTS: All three SAE occurred following the injection of the same reference of bone cement. The incriminated batches were rapidly placed in quarantine. Analysis by the manufacturer revealed no defects in production quality requirements but suggested the possibility of Bone Cement Implantation Syndrome (BCIS). A literary review on BCIS confirmed that this rare intraoperative complication was plausible in all three cases. Management of these SAE via a health care safety process enabled to provide a rapid answer concerning the causality of the cement and practice deviations of its use. CONCLUSIONS: Systemic analysis completed by the manufacturer's analysis provided corrective actions for professional practices. Implementation and efficacy of these actions will be monitored as part of the facility's programme for the improvement of quality and patient safety.