Model Number N/A |
Device Problems
Device Ingredient or Reagent Problem (2910); Improper Chemical Reaction (2952)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: foreign: sweden.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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It was reported that the bone cement has long setting time, approximately 14-15 minutes after vacuum mixing.The cement has a longer sticky and dough phases and it feels very soft during application.No consequences or impact 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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Upon further assessment of the reported event, it was determined that medwatch report should not have been filed as there was no indication that the device caused or contributed to a serious injury.Given this information, this medwatch report will be voided.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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Upon further assessment of the reported event, it was determined that medwatch report should not have been filed as there was no indication that the device caused or contributed to a serious injury.Given this information, this medwatch report will be voided.
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Search Alerts/Recalls
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