Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/10/2022 |
Event Type
Injury
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Event Description
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It was reported that there was a revision for an unknown reason.Attempts have been made and no additional information is available at this time.
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis; 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: 0001822565 - 2022 - 00384.
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis; 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: 0001822565 - 2022 - 00384.
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Event Description
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It was reported that there was a revision for an unknown reason.Attempts have been made and no additional information is available at this time.
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Event Description
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No additional information is 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.The following sections were updated: b4, b5, d6, g3, g6, h2, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.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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Search Alerts/Recalls
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