Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Cardiac Arrest (1762); Death (1802)
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Event Date 05/12/2017 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).Report source- foreign.The event occurred in (b)(4).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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Event Description
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It was reported that during a procedure, the patient experienced hemodynamic shock and hypotension when the cement was injected into the femur.The surgeon was able to complete the procedure.During post-operative monitoring, patient went in to cardiac arrest, could not be resuscitated, and expired.No further information has been made available at this time.
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Manufacturer Narrative
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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 (b)(4).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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Search Alerts/Recalls
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