Model Number N/A |
Device Problem
Improper Chemical Reaction (2952)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.
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Event Description
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It was reported that the cement could not be processed, because it solidified too quickly, within 6-7 minutes.No health consequences to patient were reported.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Product was not returned or pictures not provided.Visual device evaluation could not be performed.A retained sample of the batch has been tested in the laboratory under standardized conditions.No unusual behaviour during mixing, handling or setting.The reported behaviour of the cement cannot be reproduced.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.This device is used for treatment.Reported event is not related to medical condition.Review of medical record is not applicable.The root cause of the reported issue is attributed to a use error due to the non-respect of the ifu which explains potentially the reported issue.(mixing 45 sec instead of 30sec).A communication has been sent to the customer.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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