Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Information (3190)
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Event Date 11/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Reporting source- (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that a trilogy shell could not be firmly fixed with the hybrid offset shell inserter.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental 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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