Catalog Number 110034355 |
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 10/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that the cement began to set earlier than expected.The cement also did not generate the heat it normally does during the hardening process.This event is related to a malfunction that could potentially lead to serious injury.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).D10: medical product: part#42-5026-066-02 lot#65873156 itemname#psn fem cr cmt cocr std sz9 r part#42-5320-075-02 lot#66021872 itemname#psn tib stm 5 deg sz f r part#42-5570-001-14 lot#66191407 itemname#psn straight hyb st 14 x +30 m part#42-5221-008-10 lot#65993376 itemname#psn mc ve asf r 1 0mm 8-11 ef part#00-5970-000-67 lot#zb23ebico1 itemname#psi psn pref cr pin goe set part#110034355 lot#w18bab0603 itemname#refobacin bone cement r 1x40 us part#42-5402-000-35 lot#66030393 itemname#all poly pat ve 35 mm dia investigation of this incident is currently ongoing.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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No product was returned or pictures provided; visual evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.Reported event did occur in an operating room or as part of a medical procedure, but review of the medical records has not been performed, as the event is not related to the medical procedure.With the available information, a definitive root cause could not 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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