Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a right knee surgery, the components were opened to be implanted.When the femoral component was opened, it was noted the box contained a left femoral knee component.This resulted in a 30 minute surgical delay.The device was not implanted.There was no consequences or impact to the patient.
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Manufacturer Narrative
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(b)(4).Foreign - italy.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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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: proposed component (annex g) code is mechanical (g04) - femur.Visual examination of the returned product identified found part#183126 was found in the package of part#183106.The device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to a manufacturing issue.Actions were initiated to further investigate this issue.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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