Model Number N/A |
Device Problem
Migration (4003)
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Patient Problems
Pain (1994); No Information (3190)
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Event Date 12/24/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Explant date: unknown day in (b)(6) 2019.Report source: (b)(6).Customer has not indicated whether or not the product will 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 was reported that a patient was revised due to subsidence.There is no additional information at this time.
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Manufacturer Narrative
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This report is being submitted to update the event date and explant date.Updated: b3, b4, b5, d7, g4, g7, h1, h2, and h10.
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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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This follow-up is being submitted to relay additional information.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot 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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