Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Failure of Implant (1924)
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Event Date 07/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Revision hasn't occured yet.
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Event Description
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It was reported that the plate broke after 3 months of recuperation.The patient did not fall or did any thing that was not recommended.It was reported that the patient was diabetic and was recuperating well.The patient will be re-operated to fix the issue.There was no injury to the patient, body or health.Attempts have been made and there is no further information at this time.
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Manufacturer Narrative
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(b)(4).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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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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