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 01/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report 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 bone cement hardened faster than normal.It took about 5 minutes from the start of the mixing.Fifteen minute delay to replace the product.No health consequences to the patient.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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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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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 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.The reported event is not related to a medical condition.A review of the 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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Search Alerts/Recalls
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