(b)(4).Multiple mdr's were submitted for this event.Please see reports: 3006946279 - 2017 - 00253.3006946279 - 2017 - 00254.3006946279 - 2017 - 00255.3006946279 - 2017 - 00256.(b)(4).Concomitant products: 3020830401, refobacin plus bone cement 40 , qty 4, lots: a642bj2508, a651cj1703, a644bj2507, a705ak0104 report source- foreign.The event occurred in (b)(6).The product within this report is a combination product.Reserve sample was evaluated under standardized conditions and no failure of the bone cement was found; the product functioned as intended.Investigation results concluded that the reported event was likely due to a known risk, known as implantation syndrome.This risk is addressed in the instructions for use (ifu) of this device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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It was reported that during a procedure, the patient experienced decrease in blood pressure as the prosthesis was cemented.The surgery was ended by closing the arthrotomy.The patient was transferred to the intensive care unit where a cardiac ultrasound showed evidence of a cement embolism.Despite the reanimation measures taken, the patient expired.No further information is available at this time.
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(b)(4).An investigation has been performed, consisting of a product analysis and a documentary review.The documentary review showed that products were manufactured according to the pre-defined specifications of biomet france.Product analysis on retained samples from the same batch showed no unusual behaviour during mixing, handling or setting.The most probable reason for death is the cement implantation syndrome.This risk is described in the ifu provided with the product.No non-conformity has been detected concerning the products.
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