Model Number N/A |
Device Problems
Chemical Problem (2893); Improper Chemical Reaction (2952)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign source: japan.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 during surgery, the bone cement hardened within 5 minutes after mixing.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 retain sample of batch y46dak2201 has been tested in the laboratory under standardized conditions (23°c; rel.Humid >=40 %).No unusual behavior during mixing, handling or setting.The reported behavior 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.A definitive root cause cannot be determined.No further actions have been initiated as a result of the reported event investigation.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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