Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problem
Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown m2a cup, unknown stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2018 -11395.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in patient.
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Event Description
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It was reported that the patient underwent an initial hip surgery on an unknown date.Subsequently, the patient is suffering from elevated metal ions and discomfort.No revision reported.Additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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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.Device not returned for evaluation.
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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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