Model Number N/A |
Device Problem
Failure to Align (2522)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).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.
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Event Description
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It was reported that g7 liner would not sit upon impaction into the matching sized g7 acetabular shell.Surgery was completed with a new implant.Attempts have been made and additional information on the reported event is unavailable.
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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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Udi- (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the liner identified poly string hanging from the locking feature.There were also other visible damages on the locking features as well as scallops.These damages were likely caused during an attempt to impact the liner with the shell and during removal.Dhr was reviewed and no discrepancies were found.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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