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 09/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).G2 ¿ foreign ¿ switzerland.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 the surgery the cement was difficult to mix, right from the start.The cement was placed on the tibia part without complications, however when it was applied to the femoral part it was almost impossible to get the cement out of the cement syringe.The cement was already hardening.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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This follow-up report is being submitted to relay additional information.Product was not returned, or pictures not provided.Visual device evaluation could not be performed.A retain sample has been tested in the laboratory under standardized conditions.No unusual behavior during mixing, handling or setting.The reported behavior 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.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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