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 12/29/2016 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).(b)(4).Report source- foreign.The event occurred in (b)(4).The product within this report is a combination product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 decrease of the blood pressure followed by a cardiac arrest as the prosthesis was cemented.The patient was recovered after cardiovascular reanimation.Upon waking, the patient presented with several cardiac arrests that gave rise to several reanimations during 2hours and 5 minutes.After consultation, decision to stop the reanimation was made.The patient 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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