Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Source: (b)(6).Concomitant medical products: unknown head.Multiple reports were submitted along with this report 0001825034-2021-01588.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.
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Event Description
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It was reported that the patient underwent an initial hip arthroplasty on an unknown date.Subsequently, the patient was revised due to unknown reasons.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 and corrected information.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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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