Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Cyst(s) (1800)
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Event Date 01/29/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown spacer, pn unknown, ln unknown.Multiple mdr reports were filed for this event.Please see reports: 0001825034-2019-00374.Customer has indicated that the product will not 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 an unexpected seroma formation was found post revision of spacer and femoral neck.Subsequently, patient underwent a procedure to drain the seroma.Attempts have been made and additional information on the reported event is unavailable at this time.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. reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies 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.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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