Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Fall (1848); Bone Fracture(s) (1870)
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Event Date 10/16/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).(b)(4).Concomitant medical product: persona partial cemented femoral, catalog #: 42558000501 lot #: 63453572; persona partial articular surface, catalog #: 42518200508 lot #: 63449771.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product remains implanted.
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Event Description
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It was reported that the patient had fallen and sustained a displaced fracture of the fibula.The fracture was treated with a hinged brace.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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The follow-up report is being submitted to relay additional information.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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Manufacturer Narrative
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Reported event was confirmed through clinical notes.Dhr was reviewed and no discrepancies relevant to the reported event 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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It was reported that the patient had fallen and sustained a displaced fracture of the fibula.The fracture was treated with a hinged brace and physio.Attempts have been made and no further information has been provided.
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Search Alerts/Recalls
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