Model Number N/A |
Device Problems
Difficult to Insert (1316); Difficult To Position (1467)
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Patient Problem
No Information (3190)
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Event Date 03/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(6).
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Event Description
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It was reported that a liner would not seat in the mating implant.Attempts have been made, and no further information has been provided.
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Manufacturer Narrative
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Reported event was confirmed by review of photographs and evaluation of device.Upon visual inspection indentation was on the outside radius of the liner.The locking ring was twisted and did not fully seat into the shell.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was likely due to misalignment of the liner during the liner insertion.Root cause was unable to be determined 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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