Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 10/15/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign.The event occurred in (b)(6).The patient was primarily implanted in 2002 and revised in 2012 on an unknown device, unknown appendage, and this device was revised on (b)(6) 2014.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 was reported the patient was revised to address a poly exchange.No further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: reported event was unable to be confirmed due to limited information received from the customer.Device history record 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 event information available at the time of this report.
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Search Alerts/Recalls
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