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 06/24/2022 |
Event Type
malfunction
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Event Description
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It was reported that the cement was setting up super fast.No known impact or consequences to the patient.Attempts have been made and no further information has been provided.
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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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No further event information available at the time of this report.
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Manufacturer Narrative
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The product was not returned or pictures not provided.Device evaluation could not be performed.A retain sample of batch ay26ci2901 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.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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Search Alerts/Recalls
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