REFOBACIN BONE CEMENT R 1X40-3

Description of Event or Problem

It was reported that during injection of bone cement for a tumor-related hip reconstruction, the patient experienced cardiovascular collapse consistent with a suspected bone cement reaction, requiring advanced resuscitation and extracorporeal membrane oxygenation (ECMO) support.During the procedure, after the surgical site and medullary cavity were irrigated, a medullary plug was placed, and bone cement was mixed and injected. During cement injection, the patient developed persistent hypotension and bradycardia, oxygen saturation could not be measured, and the patient was unresponsive to verbal stimuli. Resuscitation was initiated, including endotracheal intubation for assisted ventilation, external chest compressions, an intravenous bolus of epinephrine, and a continuous infusion of norepinephrine. The patient gradually regained a spontaneous heart rate, oxygen saturation trended toward normal, and blood pressure began to rise. The lead surgeon proceeded to rapidly implant a tumor¿modified hip prosthesis and concluded the surgery. Following suturing, resuscitation continued due to persistent hemodynamic instability, requiring ongoing chest compressions and high¿dose vasoactive support. After discussion with the family and consent, a cardiac surgeon initiated ECMO therapy.The patient was discharged in a comatose state with unstable vital signs.Attempts have been made and no further information has been provided.

Additional Manufacturer Narrative

(b)(4).D4 - This product is sold outside the US and therefore no GUDID information exists. This device is considered similar to 00880304990197.G2 - Foreign: Event occurred in China.G4 - The reported product is not sold in the US, the pre-market submission number for the similar product sold in the US is K171540.The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental MedWatch 3500A will be submitted.