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 09/09/2023 |
Event Type
malfunction
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Event Description
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It was reported that the cement cured faster than usual, in four minutes.Delay 0-15min, no consequences or harm to the patient.Attempts have been made and all additional information received has been included in this report.
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Manufacturer Narrative
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(b)(4).G2- 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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The product was not returned or pictures were not provided.Visual device evaluation could not be performed.A retain sample of 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.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.This device is used for treatment.The reported event is not related to medical condition.Review of medical record is not applicable.A definitive root cause cannot be determined.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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