Model Number N/A |
Device Problem
Difficult or Delayed Positioning (1157)
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Patient Problem
No Code Available (3191)
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Event Date 02/02/2019 |
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)(4).Report source: (b)(6).
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Event Description
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It was reported that the ringloc on the cup was defective and prevented the liner from seating into the cup.The surgery was completed with another cup.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned shell showed one of two tabs of the locking ring were seized in the locking ring groove.Device history record (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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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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