Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Fall (1848)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.
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Event Description
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It was reported the patient fell and suffered a humerus fracture.The patient is scheduled for a left distal body revision, but has not yet been revised.No further information is available 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.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 information available at the time of this reporting.
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Search Alerts/Recalls
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