Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).42532008302 - tibia cemented 5 degree stemmed right size h - 65132765.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 will be submitted.
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Event Description
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It was reported that the poly would not engage and lock into place.A second poly was opened and clicked right in.It was noted that the surgeon tried to insert the first poly without cleaning the tray out first.There was no consequences or impact to the patient.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified signs of use and showed flared damages.No compression damage was noted from the provided picture.The device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue was attributed to the user not following the instruction in the surgical technique.The surgical technique advises removing the debris in the joint space before implanting.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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