Model Number N/A |
Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Bradycardia (1751); Foreign Body Reaction (1868)
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Event Date 01/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source- foreign.The event occurred in (b)(6).The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that a moment after implantation of cement blood pressure dropped suddenly and bradycardia was observed.
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Manufacturer Narrative
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(b)(4).The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non-conformity has been detected which could be linked to the issue and the root cause could not be determined.This complaint is closed but could be reopened if the product is received later.Please note that bone cement implantation syndrome is a known risk with cement.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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Search Alerts/Recalls
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