Model Number N/A |
Device Problem
Malposition of Device (2616)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Udi # (b)(4).Customer has indicated that the product will not 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 has been reported that patient had initial total reverse shoulder arthroplasty.Subsequently within one (1) month from initial surgery, patient was revised as glenosphere disassociation.It did not sit all the way down during initial surgery.No additional patient consequences were reported.
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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