Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
Foreign Body Reaction (1868); Failure of Implant (1924)
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Event Date 12/03/2010 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.
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Event Description
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It was reported a patient underwent a left acl repair.Subsequently, during the procedure, a screw fractured at the base.Partial screw remains within the patient¿s knee, while the fractured base was retrieved.The surgery was successfully completed and no additional complications have been reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of medical records provided a timeline of events and did not enhance the investigation.Device history record was reviewed and no discrepancies were found.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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