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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 04/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).Report source: foreign: country: (b)(6).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01948, 0001822565-2020-01623.
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Event Description
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It was reported the patient underwent initial tha.Subsequently, the patient suffers from unknown post operative complications approximately 1 year later.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D4: udi#(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history records identified deviations or anomalies during manufacturing, however, the deviations or anomalies would not have attributed to the event.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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