Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Code Available (3191)
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Event Date 12/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 110010243 ¿ g7 shell ¿ 6547227.010000926 ¿ g7 e1 poly liner ¿ 6487288.Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for the investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00181, 0001825034-2020-00183.
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Event Description
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It was reported that during a hip procedure, two liners were not able to be assembled with a shell.The surgery was finished with back up product.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.A final response was requested and provided to the customer.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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Search Alerts/Recalls
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