Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product remains implanted at this time.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 patient is being considered for a right hip revision with a pmi device after an unknown amount of time post implantation due to unknown reasons.No revision has been reported to date.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 information.Reported event is unable to be confirmed due to limited information provided by the customer.Dhr was unable to be reviewed as the lot number for the device is unknown.The root cause is unable to 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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Event Description
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No additional event information to report at this time.
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Search Alerts/Recalls
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