Model Number N/A |
Device Problems
Positioning Failure (1158); Activation Problem (4042)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 01/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown cup.Unknown liner.Unknown head.Unknown stem.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.
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Event Description
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It was reported that during an initial hip arthroplasty, the screw passed through the cup and was left in the patient.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
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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 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 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.Device remains implanted in the patient.
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Search Alerts/Recalls
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