Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported by 411 that a patient underwent a hip arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision on an unknown day for an unknown reason.The sales representative was requesting information on apr liner removal.No additional information.
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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 (dhr) 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.
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Search Alerts/Recalls
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